Keywords guideline - miscarriage - ectopic pregnancy - pregnancy of unknown localization
I Guideline Information
Guidelines program of the DGGG, OEGGG and SGGG
More information on the program is available at the end of the guideline.
Citation format
Early Pregnancy Loss in the 1st Trimester. Guideline of the DGGG, OEGGG and SGGG (S2k-Level,
AWMF Registry No. 015/076; August 2024). Geburtsh Frauenheilk 2025; 85: 282–310
Guideline documents
The complete long version in German, a slide version of this guideline, and a list
of the conflicts of interest of all authors is available on the homepage of the AWMF:
http://www.awmf.org/leitlinien/detail/ll/015-074.html
Guideline authors
See [Tables 1 ] and [2 ].
Table 1 Lead and/or coordinating guideline authors.
Author
AWMF professional society
Prof. Dr. med. Matthias David
German Society for Gynecology and Obstetrics [Deutsche Gesellschaft für Gynäkologie und Geburtshilfe e. V. ] (DGGG)
Prof. Dr. med. Sven Becker
German Society for Gynecology and Obstetrics (DGGG)
Table 2 Involved professional societies, organizations, etc.
DGGG working group/AWMF/non-AWMF professional society/organization/association
Professional Association of Gynecologists [Berufsverband der Frauenärzte e. V. ] (BVF)
German Society for Gynecology and Obstetrics (DGGG)
Gynecological Endoscopy Working Group [Arbeitsgemeinschaft für Gynäkologische Endoskopie ] (AGE)
Gynecology and Obstetrics Working Group [Arbeitsgemeinschaft für Gynäkologie und Geburtshilfe ] (AGG)
Working Group on Ultrasound Diagnostics in Gynecology and Obstetrics [Arbeitsgemeinschaft für Ultraschalldiagnostik in Gynäkologie und Geburtshilfe ] (ARGUS)
German Society for Gynecological Endocrinology and Reproductive Medicine [Deutsche Gesellschaft für Gynäkologische Endokrinologie und Fortpflanzungsmedizin
e. V. ] (DGGEF)
German Society for Psychosomatic Gynecology and Obstetrics [Deutsche Gesellschaft für Psychosomatische Frauenheilkunde und Geburtshilfe e. V. ] (DGPFG)
German Society for Reproductive Medicine [Deutsche Gesellschaft für Reproduktionsmedizin e. V. ] (DGRM)
German Society for Ultrasound in Medicine [Deutsche Gesellschaft für Ultraschall in der Medizin e. V. ] (DEGUM)
German Society of Pathology [Deutsche Gesellschaft für Pathologie e. V. ] (DGP)
German Society for Clinical Chemistry and Laboratory Medicine [Deutsche Gesellschaft für Klinische Chemie und Laboratoriumsmedizin e. V. ] (DGKL)
German Society of Human Genetics [Gesellschaft für Humangenetik e. V. ] (GfH)
Austrian Society for Gynecology and Obstetrics [Österreichische Gesellschaft für Gynäkologie und Geburtshilfe ] (OEGGG)
Swiss Society for Gynecology and Obstetrics [Schweizerische Gesellschaft für Gynäkologie und Geburtshilfe ] (SGGG)
The following professional societies/working groups/organizations/associations nominated
representatives to assist in the compilation of the guideline ([Table 2 ]).
Involvement of target patient group
Organization: Online forum fehlgeburt.info
The structured consensus process was moderated by Dipl.-Biol. Simone Witzel (AWMF-certified
guidelines consultant/moderator).
II Guideline Application
Purpose and objectives
The guideline aims to improve and standardize diagnostic and therapeutic approaches
for different types of miscarriages, pregnancies of unclear localization, and ectopic
pregnancies in the 1st trimester of pregnancy.
The following content-related objectives of the guideline were defined:
Provide information on laboratory-based, ultrasonography and genetic diagnostics
Present and assess different therapeutic options in terms of success and complication
rates and the continued fertility of the patient
Include aspects of the grieving process and coming to terms with the loss after an
early loss of pregnancy
Targeted areas of care
Target user groups/target audience
This guideline is aimed at:
gynecologists and obstetricians
professional medical societies
working groups
organizations involved in the compilation of the guideline
patients
Adoption and period of validity
The validity of this guideline was confirmed by the executive boards/representatives
of the participating medical professional societies, working groups, organizations,
and associations as well as the boards of the DGGG and the DGGG Guidelines Commission
and of the SGGG and OEGGG in July 2024 and was thereby approved in its entirety. This
guideline is valid from 1 September 2024 through to 31 August 2029. Because of the
contents of this guideline, this period of validity is only an estimate.
III Method
Basic principles
The method used to prepare this guideline was determined by the class to which this
guideline was assigned. The AWMF Guidance Manual (version 1.0) has set out the respective
rules and requirements for different classes of guidelines. Guidelines are differentiated
into lowest (S1), intermediate (S2), and highest (S3) class. The lowest class is defined
as consisting of a set of recommendations for action compiled by a non-representative
group of experts. In 2004, the S2 class was divided into two subclasses: a systematic
evidence-based subclass (S2e) and a structural consensus-based subclass (S2k). The
highest S3 class combines both approaches.
This guideline was classifed as: S2k
Grading of recommendations
The grading of evidence based on the systematic search, selection, evaluation, and
synthesis of an evidence base which is then used to grade the recommendations of the
guideline is not envisaged for S2k guidelines. The individual statements and recommendations
are only differentiated by syntax, not by symbols ([Table 3 ]).
Table 3 Grading of recommendations (based on Lomotan et al., Qual Saf Health Care 2010).
Description of binding character
Expression
Strong recommendation with highly binding character
must/must not
Regular recommendation with moderately binding character
should/should not
Open recommendation with limited binding character
may/may not
Statements
Expositions or explanations of specific facts, circumstances, or problems without
any direct recommendations for action included in this guideline are referred to as
“statements.” It is not possible to provide any information about the level of evidence for these statements.
Achieving consensus and level of consensus
At structured NIH-type consensus conferences (S2k/S3 level), authorized participants
attending the session vote on draft statements and recommendations. The process is
as follows. A recommendation is presented, its contents are discussed, proposed changes
are put forward, and all proposed changes are voted on. If a consensus (> 75% of votes)
is not achieved, there is another round of discussions, followed by a repeat vote.
Finally, the level of consensus is determined, based on the number of participants
([Table 4 ]).
Table 4 Level of consensus based on extent of agreement.
Symbol
Level of consensus
Extent of agreement in percent
+++
Strong consensus
> 95% of participants agree
++
Consensus
> 75 to 95% of participants agree
+
Majority agreement
> 50 to 75% of participants agree
–
No consensus
< 51% of participants agree
Expert consensus
As the term already indicates, this refers to consensus decisions relating specifically
to recommendations/statements issued without a prior systematic search of the literature
(S2k) or where evidence is lacking (S2e/S3). The term “expert consensus” (EC) used
here is synonymous with terms used in other guidelines such as “good clinical practice”
(GCP) or “clinical consensus point” (CCP). The strength of the recommendation is graded
as previously described in the chapter Grading of recommendations but without the use of symbols; it is only expressed semantically (“must”/“must not”
or “should”/“should not” or “may”/“may not”).
IV Guideline
Preamble
When caring for and treating patients who have suffered an early loss of pregnancy
(miscarriage, ectopic pregnancy), medical and nursing staff are expected to show a
sensitive and empathetic approach to the individual patientʼs psychological situation
in the same way they would be expected to deal with other clinical disorders. Patients
in the same clinical situation may have different ideas about the right approach for
themselves. However, an empathetic response to the patientʼs wishes assumes that the
situation is not life-threatening as this would need to be expressly pointed out to
the affected woman. Treatment recommendations must always be guided by medical requirements.
But it is important to bear in mind that the patient will have to cope with the experience
of loss for a long time to come.
Affected women have the right to be supported by a midwife before, during and after
a miscarriage.
Definition of disorders of early pregnancy
An early loss of pregnancy is defined as a non-viable pregnancy with an empty gestational
sac or a gestational sac with an embryo or fetus without cardiac activity in the first
12 weeks of pregnancy post conception, localized inside or outside the uterus (modified
from [1 ]).
The aim of this guideline is to improve the care provided to affected women who suffer
an early loss of pregnancy.
The guideline reviews practice-based diagnostic approaches and current treatment options
for early loss of pregnancy.
Early loss of an intrauterine or ectopic pregnancy is quite common and probably occurs
in at least 10 to 15% of all clinically detected pregnancies, which amounts to about
23 million miscarriages annually [1 ], [2 ], [3 ]. Around 80% of all pregnancy losses occur in the first trimester of pregnancy [1 ]. This is a significant burden on resources in the healthcare sector. In Great Britain,
for example, it is associated with more than 50 000 hospital admissions every year
[2 ].
Most affected women are not aware of how common early loss of pregnancy is. While
an early loss of pregnancy represents a routine situation for doctors, the unfavorable
pregnancy outcome is usually unexpected for the patient and can be psychologically
very stressful. After treatment for miscarriage or ectopic pregnancy, the patient
may experience symptoms of depression, anxiety, and post-traumatic stress disorder
[4 ]. It is therefore important that the psychological impact of an early loss of pregnancy
on the affected woman receives sufficient attention during her medical care. From
a medical perspective, the focus must be initially on confirming the diagnosis and
averting danger to the patient and managing the (“somatic”) emergency situation.
If the clinical situation permits, gynecologists must explain and offer the whole
range of options available to treat miscarriage or suspected ectopic pregnancy to
patients which, in addition to expectant management, also includes drug treatment
and surgery.
If women exhibit no emergency symptoms or medical complications which require urgent
surgical intervention, planned treatment may accommodate the patientʼs preferences
after she has been informed in detail about the risks and advantages of each option
[1 ]. The aim is to develop an individual treatment path based on shared decision-making.
Confirmation of the diagnosis is essential before starting treatment as it is important
to differentiate an intact pregnancy from a miscarriage, an ectopic pregnancy, trophoblastic
disease or molar pregnancy, or a pregnancy of unclear localization.
All recommendations and statements of the guideline are presented below.
Pregnancy of unclear localization
Consensus-based recommendation 2.E1
Expert consensus
Level of consensus +++
The diagnostic workup and definition of a pregnancy of unclear localization must include
the patientʼs gynecological history (especially her prior cycle history), a clinical
examination, transvaginal ultrasound, and quantitative determination of β-hCG.
Consensus-based recommendation 2.E2
Expert consensus
Level of consensus +++
Combining a single β-hCG value with sonographic imaging showing an empty uterine cavity
must not immediately lead to the diagnostic assumption of an ectopic pregnancy.
Consensus-based recommendation 2.E3
Expert consensus
Level of consensus ++
If a pregnancy of unclear localization is suspected, the changes in β-hCG levels should
be determined after 48 hours and transvaginal ultrasound examinations should be carried
out.
Consensus-based recommendation 2.E4
Expert consensus
Level of consensus ++
Invasive diagnostic or therapeutic procedures should only be used if the patient has
otherwise unexplained pain symptoms or persistent pregnancy of unclear localization.
Consensus-based statement 2.S1
Expert consensus
Level of consensus +++
Use of the M6/M6NP (and M4) models to triage pregnant women with a pregnancy of unclear
localization can be useful to support clinical decision-making.
Miscarriage/spontaneous abortion
Consensus-based recommendation 3.E5
Expert consensus
Level of consensus +++
If a disorder of early pregnancy is suspected, the changes in β-hCG concentrations
over time should be monitored. If there is bleeding, blood group determination including
Rhesus factor determination should be carried out.
Consensus-based statement 3.S2
Expert consensus
Level of consensus +++
A speculum examination may be carried out to confirm whether genital bleeding is uterine
bleeding. Palpation during gynecological examination is done mainly to diagnose the
cause of acute pain with suspected ectopic pregnancy or, if the cervix is dilated,
to diagnose imminent miscarriage. Tenderness of one of the adnexa on palpation may
serve to quickly identify an acute situation in a case with ectopic pregnancy.
Consensus-based recommendation 3.E6
Expert consensus
Level of consensus +++
Transvaginal sonography should be the preferred diagnostic approach for symptomatic
women to localize the pregnancy and assess the current situation in the event of a
miscarriage.
Consensus-based recommendation 3.E7
Expert consensus
Level of consensus +++
Unless there is a defined emergency situation, the patient should be informed about
the alternatives “expectant approach” and “interventional approach”.
Treatment options
1. Expectant approach
Consensus-based recommendation 3.E8
Expert consensus
Level of consensus +++
The patient must be informed about the risks associated with each type of approach
(expectant/drug-based/surgical).
Consensus-based recommendation 3.E9
Expert consensus
Level of consensus +++
If an expectant approach is chosen, the information provided to the patient about
the risk of requiring surgical intervention or a drug-based approach should be recorded.
Consensus-based recommendation 3.E10
Expert consensus
Level of consensus +++
Patients with spontaneous abortion should also be offered an expectant approach once
any contraindications have been excluded.
Consensus-based recommendation 3.E11
Expert consensus
Level of consensus +++
Women suffering a miscarriage who opt for an expectant approach must be informed about
what they can expect during the entire process of the miscarriage including pain,
and they must receive treatment suggestions for pain relief.
Consensus-based recommendation 3.E12
Expert consensus
Level of consensus +++
Non-steroidal anti-inflammatory drugs such as ibuprofen or metamizole should be recommended
as pain relief to women who opt for an expectant approach when suffering a miscarriage
in the first trimester of pregnancy.
Consensus-based recommendation 3.E13
Expert consensus
Level of consensus +++
If the patient has opted for an expectant approach, she must be informed that it can
take longer until the miscarriage is complete and that it may be accompanied by increased
blood loss and severe pain.
Consensus-based recommendation 3.E14
Expert consensus
Level of consensus +++
The patient must be informed about the necessity of surgical or drug-based follow-up
treatment in the event that the miscarriage is incomplete.
Consensus-based recommendation 3.E15
Expert consensus
Level of consensus +++
If an expectant approach was chosen, progress should be monitored by transvaginal
ultrasound examination within 7 to 14 days.
Consensus-based statement 3.S3
Expert consensus
Level of consensus +++
An additional transvaginal ultrasound examination may be carried out in the event
of persistent menstrual-type bleeding, pain, or signs of infection during the miscarriage.
Depending on the findings, a change in approach (drug-based, surgical) may be discussed
with the patient.
Consensus-based recommendation 3.E16
Expert consensus
Level of consensus +++
In the event of a missed abortion, if bleeding has still not occurred, the patient
should be offered another examination after 14 days at the latest as an alternative
to changing the approach initially agreed upon.
Consensus-based recommendation 3.E17
Expert consensus
Level of consensus +
After a spontaneous abortion, Rh D-negative pregnant women must only receive anti-D
prophylaxis if the gestational age is > 9 + 0 weeks of gestation.
Consensus-based recommendation 3.E18
Expert consensus
Level of consensus +++
Women must be informed about the variable course of bleeding and pain, the potential
use of non-steroidal anti-inflammatory drugs for pain relief, and the possibility
of another conception as well as necessary contraceptive measures, if required.
Consensus-based recommendation 3.E19
Expert consensus
Level of consensus +++
Women must not be advised to avoid tampons, menstruation cups, sexual intercourse,
physical exertion or similar as the evidence for this is lacking.
Consensus-based recommendation 3.E20
Expert consensus
Level of consensus +++
The patient must be informed about typical symptoms such as noticeably long and severe
persistent or foul-smelling bleeding and/or fever over 38 °C, which are indications
for remaining residual tissue or infection.
2. Medication-based approach
Consensus-based recommendation 3.E21
Expert consensus
Level of consensus +++
Induction of miscarriage using medication should be carried out as an ambulatory procedure.
Consensus-based recommendation 3.E22
Expert consensus
Level of consensus +++
After receiving detailed information about the different types of approach, the patient
must be able to make an informed decision about the preferred therapeutic approach.
Consensus-based recommendation 3.E23
Expert consensus
Level of consensus +++
The patient should be given information about the findings and treatment to take home
with her and should be provided with an emergency telephone number.
Consensus-based recommendation 3.E24
Expert consensus
Level of consensus +++
The patient must be informed and educated about symptoms which occur during treatment
and the signs of possible complications which require urgent treatment.
Consensus-based statement 3.S4
Expert consensus
Level of consensus +++
In cases with confirmed miscarriage (< 12th GW), the medication of choice to induce
abortion should be a combination von 200 mg mifepristone taken orally followed by
600 – 800 µg misoprostol administered vaginally after 24 h.
Consensus-based recommendation 3.E25
Expert consensus
Level of consensus ++
If the first dose does not result in any discharge of tissue or only in insufficient
discharge, a second dose of misoprostol should be taken at the earliest three hours
after administration of the first dose.
Consensus-based statement 3.S5
Expert consensus
Level of consensus ++
Misoprostol may also be administered to women with previous caesarean section or any
other transmural uterine scars.
Consensus-based recommendation 3.E26
Expert consensus
Level of consensus ++
Patients suffering a miscarriage must receive information about the three treatment
options “medication to induce abortion”, “expectant management”, and “surgical procedure”
and the information provided to the patient must be recorded.
Consensus-based recommendation 3.E27
Expert consensus
Level of consensus +++
With medication-based management, the patient must be informed about side effects
and risks and about the off-label-use status of misoprostol. All information provided
to the patient in this context must be recorded.
Consensus-based recommendation 3.E28
Expert consensus
Level of consensus +++
Antibiotic prophylaxis must not be administered if medication is used to induce abortion.
Consensus-based recommendation 3.E29
Expert consensus
Level of consensus +++
All contraindications must be considered and weighed up before the administration
of medication to induce abortion.
Consensus-based recommendation 3.E30
Expert consensus
Level of consensus +++
Non-steroidal anti-inflammatory drugs, especially ibuprofen and oral metamizole, should
be used to achieve adequate pain management.
Consensus-based recommendation 3.E31
Expert consensus
Level of consensus +++
An anti-emetic such as dimenhydrinate, metoclopramide, or ondansetron should be offered
because of possible nausea and vomiting associated with the use of misoprostol.
Consensus-based statement 3.S6
Expert consensus
Level of consensus +++
If residual intrauterine tissue is suspected without relevant bleeding, management
may consist of an expectant or medication-based approach, or vacuum aspiration may
be used.
Consensus-based recommendation 3.E32
Expert consensus
Level of consensus +++
Surgical removal of retained products of conception must be carried out if persistent
excessive menstruation-type vaginal or uterine bleeding occurs during medication-based
induction of abortion and sonography shows residual tissue.
Consensus-based recommendation 3.E33
Expert consensus
Level of consensus +++
Any suspicion of ectopic or heterotopic pregnancy must be investigated using additional
diagnostic measures.
Consensus-based recommendation 3.E34
Expert consensus
Level of consensus +++
Antibiotic therapy must be initiated immediately if there are any signs of infection.
Consensus-based recommendation 3.E35
Expert consensus
Level of consensus ++
All women who opt for medication-based induction of abortion must be advised to have
a follow-up examination to confirm complete termination of the pregnancy. The follow-up
examination must consist of transvaginal ultrasound carried out 7 to 14 days after
taking the first dose of medication.
Consensus-based statement 3.S7
Expert consensus
Level of consensus ++
As part of follow-up care after medication-induced abortion, the patient may be offered
contraception counseling, advice about the effect of the miscarriage on the patientʼs
future fertility, and information about options which can support the patient to cope
with the psychological effect of the pregnancy loss.
Consensus-based recommendation 3.E36
Expert consensus
Level of consensus ++
Womem who are Rh D-negative should receive an anti-Rh (D)-immunoglobulin dose within
72 hours after the first application of misoprostol during medication-induced abortion
of a pregnancy of > 9 + 0 weeks of gestation (comfirmed gestational age).
3. Surgical approach
Consensus-based recommendation 3.E37
Expert consensus
Level of consensus +++
With surgical management, the patient must be informed about the risks compared to
expectant and medication-based management, and the information provided must be documented.
Consensus-based recommendation 3.E38
Expert consensus
Level of consensus +++
The decision whether to carry out medication-based cervical ripening using a prostaglandin
preparation or mechanical dilators should be taken on a case-by-case basis.
Consensus-based recommendation 3.E39
Expert consensus
Level of consensus +++
If misoprostol is administered to soften the cervix, the patient must be informed
about its off-label use and the information provided to the patient must be documented.
Consensus-based statement 3.S8
Expert consensus
Level of consensus +++
Mifepristone/misoprostol may be considered for cervical priming in women who are status
post caesarean section.
Consensus-based recommendation 3.E40
Expert consensus
Level of consensus +++
No antibiotic prophylaxis must be administered for abortion curettage.
Consensus-based recommendation 3.E41
Expert consensus
Level of consensus +++
Abortion curettage should be carried out as suction curettage/vacuum aspiration.
Consensus-based recommendation 3.E42
Expert consensus
Level of consensus +++
A control ultrasound examination may be carried out intraoperatively. If complications
are suspected, a control ultrasound examination must be carried out.
Consensus-based recommendation 3.E43
Expert consensus
Level of consensus +++
The short duration of the procedure should be considered when choosing the anesthetic
procedure.
Consensus-based recommendation 3.E44
Expert consensus
Level of consensus +++
Abortion curettage should be carried out as an ambulatory procedure. A stay in hospital
may be required if there are medical, social, or logistical indications.
Consensus-based statement 3.S9
Expert consensus
Level of consensus +++
A low-dose combination of ibuprofen and paracetamol is very effective in patients.
It has few side effects and may be considered as an alternative to monotherapy (in
higher doses).
Consensus-based statement 3.S10
Expert consensus
Level of consensus +++
If the patient is experiencing moderate-to-severe pain, weak opioids such as tramadol
(50 – 100 mg) maximum dose (400 – 600 mg/day) or tilidine (50 – 100 mg) maximum dose
(400 – 600 mg/day) taken orally in combination with non-opioid analgesics may be administered
(only to patients with no contraindications) to limit the use of opioids.
Consensus-based recommendation 3.E45
Expert consensus
Level of consensus ++
Anti-D-immunoglobulin prophylaxis should be offered to all Rh D-negative women who
have undergone abortion curettage, irrespective of the gestational age of the pregnancy.
Consensus-based recommendation 3.E46
Expert consensus
Level of consensus +++
If the patient experiences severe postoperative bleeding, residual placental tissue
must always be excluded as the cause.
Consensus-based statement 3.S11
Expert consensus
Level of consensus +++
If uterine perforation is suspected, laparoscopy may be carried out and surgical remediation
if required.
Consensus-based recommendation 3.E47
Expert consensus
Level of consensus +++
Cervical injuries should be treated surgically.
Consensus-based recommendation 3.E48
Expert consensus
Level of consensus +++
If the miscarriage is a septic abortion, curettage must be carried out under antibiotic
coverage.
Consensus-based recommendation 3.E49
Expert consensus
Level of consensus +++
If a pathological examination is requested, each embryo/fetus and all embryonic or
fetal parts must be at least subjected to an external examination. Decidual tissue,
chorionic villi, and embryonic tissue must be identified during macroscopic assessment
of the abraded or expelled tissue. The assessment of the embryo must also record,
if possible, the height, weight, crown-rump and foot length as well as any anomalies
or malformations.
Consensus-based recommendation 3.E50
Expert consensus
Level of consensus +++
All aborted tissue should be subjected to histopathological examination.
Consensus-based recommendation 3.E51
Expert consensus
Level of consensus +++
The pathomorphological assessment of aborted tissue must include a statement on whether
the pregnancy was an intrauterine or extrauterine pregnancy. The implantation site
must be searched for if only individual chorionic villi can be detected. If no chorionic
villi, implantation zone or trophoblast cells can be identified, all the submitted
aborted fetal tissue must be embedded and examined microscopically.
Consensus-based recommendation 3.E52
Expert consensus
Level of consensus +++
The diagnostic assessment of the aborted fetal tissue must evaluate the pathophysiological
changes and extent of any regressive postmortem changes to chorionic villi tissue
based on the gestational age calculated and diagnosed on imaging.
Consensus-based recommendation 3.E53
Expert consensus
Level of consensus +++
Sequential β-HCG measurements must be carried out if the histological examination
confirms the presence of a trophoblastic tumor.
Consensus-based recommendation 3.E54
Expert consensus
Level of consensus +++
Immunohistochemical p57 staining must be carried out to clearly differentiate between
a partial molar pregnancy and a hydatidiform mole.
Consensus-based recommendation 3.E55
Expert consensus
Level of consensus +++
Immunohistochemical CD163 or CD68 staining must be carried out if chronic histiocytic
intervillositis (CHI) is suspected.
Consensus-based recommendation 3.E56
Expert consensus
Level of consensus +++
Aborted fetal tissue should be given a dignified burial in accordance with the specific
regulations in the respective German federal state, and the parents should be informed
about the burial in an appropriate manner.
Consensus-based recommendation 3.E57
Expert consensus
Level of consensus +++
Women must be informed about the variable course of bleeding and pain, the use of
non-steroidal anti-inflammatory medications for pain relief, and the possibility of
conception.
Consensus-based recommendation 3.E58
Expert consensus
Level of consensus +++
The patient must not be advised to avoid the use of tampons, menstruation cups, sexual
intercourse, and physical exertion as the evidence for this is lacking.
Consensus-based recommendation 3.E59
Expert consensus
Level of consensus ++
The patient must be informed about possible symptoms that are indications of residual
retained products of conception or of infection.
Special situations
1. Incipient abortion
Consensus-based recommendation 4.E60
Expert consensus
Level of consensus +++
Bed rest must not be recommended for symptoms of incipient abortion.
Consensus-based recommendation 4.E61
Expert consensus
Level of consensus +
No progesterone preparations should be administered for symptoms of incipient miscarriage
in the first trimester of pregnancy.
Consensus-based recommendation 4.E62
Expert consensus
Level of consensus +
Anti-D immunglobulin should not be administered for incipient miscarriage in the first
trimester.
2. Approach for primary incomplete spontaneous abortion
Consensus-based recommendation 4.E63
Expert consensus
Level of consensus +++
Transvaginal sonography should be carried out if incomplete abortion is suspected.
Doppler sonography may provide additional valuable information.
Consensus-based recommendation 4.E64
Expert consensus
Level of consensus +++
When incomplete abortion is suspected, all therapeutic options (expectant, medication,
surgical) should be discussed with the patient in terms to the respective success
rates and risks.
Consensus-based statement 4.S12
Expert consensus
Level of consensus +++
The approach for incomplete abortion can be expectant (up to 8 weeks) or consist of
medication-based or surgical treatment.
3. Approach for septic abortion
Consensus-based recommendation 4.E65
Expert consensus
Level of consensus +++
If septic abortion is suspected, the necessary laboratory tests must be arranged on
an emergency basis.
Consensus-based recommendation 4.E66
Expert consensus
Level of consensus +++
Treatment with broad-spectrum antibiotics must be initiated immediately for septic
abortion.
Consensus-based recommendation 4.E67
Expert consensus
Level of consensus +++
If the patient is going through septic abortion with residual intrauterine tissue
remnants, these residual products of conception must be removed surgically after the
start of antibiotic therapy.
4. Approach for heterotopic pregnancy
Consensus-based recommendation 4.E68
Expert consensus
Level of consensus +++
When an intrauterine pregnancy has been confirmed by sonography, the adnexal regions
must always be evaluated to exclude heterotopic pregnancy.
Consensus-based recommendation 4.E69
Expert consensus
Level of consensus +++
When choosing the appropriate treatment for a heterotopic pregnancy, the clinical
situation and the vital intrauterine pregnancy must be considered.
5. Subsequent pregnancy after a miscarriage in the first trimester
Consensus-based statement 5.S13
Expert consensus
Level of consensus ++
After a miscarriage in the first trimester of pregnancy, the affected woman may be
informed that she can become pregnant again without delay if there are no specific
individual reasons not to do so. Reasons to postpone pregnancy can be: a diagnostic
workup is necessary before becoming pregnant again, the affected woman is not yet
ready psychologically, or the woman is still coping with the physical consequences
of surgery.
Ectopic pregnancy
Consensus-based recommendation 6.E70
Expert consensus
Level of consensus +++
In principle, every sexually active women of child-bearing age should have a pregnancy
test if abdominal pain occurs.
Consensus-based recommendation 6.E71
Expert consensus
Level of consensus +++
The patientʼs medical history and physical examination should always also consider
the symptoms of persistent vaginal bleeding after previous secondary amenorrhea, pelvic
and/or abdominal pain, and gastrointestinal complaints, especially diarrhea.
Consensus-based recommendation 6.E72
Expert consensus
Level of consensus +++
A diagnosis of ectopic pregnancy should not be based on the clinical examination and
history alone, as the sensitivity of these factors is very limited.
Consensus-based recommendation 6.E73
Expert consensus
Level of consensus +++
In cases with symptomatic pregnancy of unclear localization, suspected ectopic pregnancy
or miscarriage, quantitative serum/plasma hCG levels must be measured using an approved
laboratory test.
Consensus-based recommendation 6.E74
Expert consensus
Level of consensus +++
Serum/plasma hCG concentrations must be determined during the examination.
Consensus-based recommendation 6.E75
Expert consensus
Level of consensus +++
The diagnosis of an ectopic pregnancy must include determination of serum β-hCG levels.
Consensus-based recommendation 6.E76
Expert consensus
Level of consensus +++
If the clinical situtation is unclear or management consists of an expectant approach,
the β-hCG level must be checked after 48 h.
Consensus-based recommendation 6.E77
Expert consensus
Level of consensus +++
To diagnose symptomatic women, the method of choice to localize the pregnancy must
be transvaginal sonography.
Consensus-based recommendation 6.E78
Expert consensus
Level of consensus +++
The aim of the diagnostic workup must be to identify and localize an ectopic pregnancy
with sonography before potentially carrying out a surgical intervention.
Consensus-based recommendation 6.E79
Expert consensus
Level of consensus +++
The diagnostic and therapeutic method of choice for suspected acute or life-threatening
bleeding ectopic pregnancy is emergency laparoscopy. The procedure must be carried
out urgently without waiting for further diagnostic tests when managing a patient
with a positive pregnancy test and presents with the clinical triad “unclear lower
abdominal pain – hemodynamically problematic situation – low hemoglobin level.”
Treatment Options
1. Expectant approach
Consensus-based recommendation 6.E80
Expert consensus
Level of consensus +++
The patient must be informed about the possibility that the ectopic pregnancy may
resolve itself and about the risks associated with expectant management, but it is
not possible to provide her with precise information about the success rate and how
long the resorption process will take.
Consensus-based recommendation 6.E81
Expert consensus
Level of consensus +++
It must be pointed out to the patient that although expectant management of a suspected
tubal pregnancy may avoid methotrexate-related and anesthesia- and surgery-related
risks, failure of expectant management may be associated with higher morbidity.
Consensus-based recommendation 6.E82
Expert consensus
Level of consensus +++
The patient must be informed that the effects of expectant management of ectopic pregnancy
on future fertility will probably be similar to those occurring after treatment with
methotrexate. But the data on this is not reliable.
Consensus-based statement 6.S14
Expert consensus
Level of consensus +++
Expectant management may be recommended to a hemodynamically stable and pain-free
patient with sonographic indications of a non-vital tubal pregnancy with a maximum
diameter of 35 mm, no signs of hemoperitoneum, and a maximum β-hCG concentration of
1000 IU/l.
Consensus-based recommendation 6.E83
Expert consensus
Level of consensus ++
If a patient with suspected tubal pregnancy opts for expectant management after she
has been informed about all the risks, the requirements for her further care (compliance,
carrying out close ambulantory monitoring) must be met.
Consensus-based recommendation 6.E84
Expert consensus
Level of consensus ++
During expectant management of a suspected ectopic pregnancy, control serum β-hCG
measurements should be carried out on days 2, 4 and 7 after the initial diagnosis.
Consensus-based recommendation 6.E85
Expert consensus
Level of consensus +++
If the β-hCG levels on days 2, 4 and 7 have decreased by 15% or more each time compared
to the previous level, the laboratory tests must be repeated every 7 days until the
β-hCG level is no longer detectable in serum.
Consensus-based recommendation 6.E86
Expert consensus
Level of consensus +++
If the β-hCG level does not decrease by 15%, does not change, or increases compared
to previously measured concentrations, the patientʼs condition must be critically
reviewed clinically and sonographically, and the decision for expectant management
must be revisited.
Consensus-based recommendation 6.E87
Expert consensus
Level of consensus +++
Surgery is indicated after a previous decision for expectant management if one or
more of the following criteria are met:
Patient has clinical symptoms;
Signs of tubal rupture and/or intraperitoneal bleeding,
Hemoperitoneum (Hb concentration < 10 g/dl);
Diameter has increased (size progression) to more than 35 mm and/or fetal heartbeat
is detectable during transvaginal ultrasound examination;
β-hCG level has risen to more than 1000 IU/l;
Patient is not sufficiently compliant;
Patient cannot obtain care close to home and there is a lack of willingness on the
part of the patient to comply with required monitoring of her progress including regular
repeat visits for clinical and sonographic examination and blood tests.
Consensus-based recommendation 6.E88
Expert consensus
Level of consensus +++
Because of the risk of Rh D alloimmunization during expectant management in non-sensitized
Rh D-negative women with suspected ectopic pregnancy, these patients should be offered
anti-D prophylaxis.
2. Medication-based therapy
Consensus-based recommendation 6.E89
Expert consensus
Level of consensus +++
All contraindications must be excluded before starting a patient on methotrexate therapy
for ectopic pregnancy.
Consensus-based recommendation 6.E90
Expert consensus
Level of consensus +++
During methotrexate therapy for suspected ectopic pregnancy, the serum β-hCG concentration
must be checked at regular intervals until β-hCG can no longer be detected.
Consensus-based recommendation 6.E91
Expert consensus
Level of consensus +++
Patients must be informed in detail about the nature of the off-label use of methotrexate
therapy and the information must be documented in writing.
Consensus-based recommendation 6.E92
Expert consensus
Level of consensus +++
The patient should be informed about the suspected diagnosis, the possible consequences
of methotrexate therapy, and the different treatment options available. If possible,
the treatment path should be decided on using a joint decision-making process.
Consensus-based recommendation 6.E93
Expert consensus
Level of consensus +++
If there are no contraindications, medication-based treatment of an ectopic pregnancy
should consist of a single intramuscular injection of methotrexate administered at
a dose of 1 mg/kg body weight or 50 mg/m2 body surface.
Consensus-based recommendation 6.E94
Expert consensus
Level of consensus +++
Specific laboratory tests (complete blood count with differential blood count, liver
enzymes (ALT [GPT], AST [SGOT], ALP), GGT, bilirubin, serum albumin, hepatitis serology,
renal retention parameters) should be carried out before every administration of methotrexate.
Consensus-based recommendation 6.E95
Expert consensus
Level of consensus ++
Women should be advised to use a reliable contraceptive method for six months after
completing methotrexate therapy.
Consensus-based recommendation 6.E96
Expert consensus
Level of consensus ++
Medication-based treatment for ectopic pregnancy should be carried out on an outpatient
basis.
Consensus-based recommendation 6.E97
Expert consensus
Level of consensus +++
Surgery must be carried out if an ectopic pregnancy is suspected and methotrexate
therapy is absolutely contraindicated.
Consensus-based recommendation 6.E98
Expert consensus
Level of consensus +++
Surgery must be carried out if an ectopic pregnancy is suspected and medication-based
treatment has failed.
Consensus-based recommendation 6.E99
Expert consensus
Level of consensus +++
All Rhesus-negative women receiving medication to treat an extrauterine pregnancy
should be given anti-D prophylaxis.
3. Surgical approach
Consensus-based statement 7.S15
Expert consensus
Level of consensus +++
A laparoscopic approach is the method of choice if the decision is taken to carry
out surgery based on a (suspected) diagnosis of tubal pregnancy.
Consensus-based recommendation 7.E100
Expert consensus
Level of consensus +++
Even if tubal pregnancy is suspected and the patient is hemodynamically unstable,
the next diagnostic and therapeutic step must consist of exploratory laparoscopy.
Consensus-based recommendation 7.E101
Expert consensus
Level of consensus +++
The decision whether to carry out salpingectomy or to preserve the fallopian tube
must depend on the clinical situation, the patientʼs medical history, and the patientʼs
wishes.
Consensus-based statement 7.S16
Expert consensus
Level of consensus +++
Vacuum extraction/curettage may be carried out at the same time if an ectopic pregnancy
is suspected, the intraabdominal laparoscopic findings to confirm the pregnancy are
unclear, and the increase in serum β-hCG levels was insufficient.
Consensus-based recommendation 7.E102
Expert consensus
Level of consensus +++
Postoperative monitoring of β-hCG concentrations must be carried out if surgery was
a tube-sparing procedure.
Consensus-based recommendation 7.E103
Expert consensus
Level of consensus +++
RhD-negative women who undergo surgery for tubal pregnancy should be given anti-D
prophylaxis.
Consensus-based recommendation 7.E104
Expert consensus
Level of consensus +++
No antibiotic prophylaxis must be administered during laparoscopic therapy of a tubal
pregnancy.
Approach for rare forms of ectopic pregnancy
1. Cervical pregnancy
Consensus-based recommendation 7.E105
Expert consensus
Level of consensus +++
A cervical pregnancy must be confirmed as early as possible.
Consensus-based recommendation 7.E106
Expert consensus
Level of consensus +++
Transvaginal sonography must be carried out as the first-choice diagnostic procedure
if there is a clinical suspicion of cervical pregnancy.
Consensus-based recommendation 7.E107
Expert consensus
Level of consensus +++
The preferred option to treat cervical pregnancy diagnosed in its early stages should
be intramuscular administration of methotrexate.
2. Caesarean scar pregnancy
Consensus-based recommendation 7.E108
Expert consensus
Level of consensus +++
Transvaginal sonography must be carried out in early pregnancy to locate the site
of pregnancy in women who have previously had a caesarean section.
Consensus-based recommendation 7.E109
Expert consensus
Level of consensus +++
When making the diagnosis, a caesarean scar pregnancy should be treated as early as
possible (ideally before 8 + 0 GW) as treatment success rates decrease and complication
rates increase with advancing gestational age.
Consensus-based recommendation 7.E110
Expert consensus
Level of consensus +++
Treatment of a caesarean scar pregnancy should not only consist of administering systemic
methotrexate.
3. Cornual ectopic pregnancy
Consensus-based statement 7.S17
Expert consensus
Level of consensus +++
3D ultrasound examination may be useful to show the general uterine anatomy and the
location of the ectopic pregnancy, in particular.
Consensus-based recommendation 7.E111
Expert consensus
Level of consensus +++
If implantation occurs in a rudimentary uterine horn, the treatment of choice should
consist of the surgical removal of the complete rudimentary uterine horn and the proximal
uterine tube.
Consensus-based recommendation 7.E112
Expert consensus
Level of consensus +++
An expectant approach to treat interstitial pregnancy should only be discussed if
the pregnancy is not viable and the β-hCG levels are decreasing and only after the
patient has been explicitly informed about the risks.
Consensus-based recommendation 7.E113
Expert consensus
Level of consensus +++
Treatment for an interstitial pregnancy should consist of surgical intervention as
it is the most effective therapeutic approach. A medication-based approach using methotrexate
(systemic/local) may be considered for carefully selected patients.
4. Ovarian pregnancy
Consensus-based recommendation 7.E114
Expert consensus
Level of consensus ++
If ovarian pregnancy is suspected, laparoscopy must be the first-choice method to
confirm the suspected diagnosis and carry out definitive therapy.
Consensus-based recommendation 7.E115
Expert consensus
Level of consensus +++
If ovarian pregnancy is suspected, surgical intervention should be carried out at
an early stage because of the high risk of hemorrhage.
Consensus-based recommendation 7.E116
Expert consensus
Level of consensus +++
When carrying out surgery for an ovarian pregnancy, the aim should be to preserve
the ovary (cyst enucleation or wedge resection).
Consensus-based recommendation 7.E117
Expert consensus
Level of consensus ++
If ovarian pregnancy is suspected, methotrexate may be considered as an alternative
first-line treatment and should be considered as an alternative second-line approach.
5. Abdominal pregnancy
Consensus-based statement 7.S18
Expert consensus
Level of consensus +++
An early abdominal pregnancy may be treated using laparoscopy.
Consensus-based recommendation 7.E118
Expert consensus
Level of consensus +++
An advanced abdominal pregnancy should be treated using laparotomy, preferably using
longitudinal laparotomy.
Consensus-based recommendation 7.E119
Expert consensus
Level of consensus +++
With an abdominal pregnancy, complete extraction of the placenta after individual
assessment of the maternal morbidity risk must only be carried out if it can be carried
out easily and the risk of hemorrhage is low.
Psychological aspects in early loss of pregnancy
Consensus-based recommendation 8.E120
Expert consensus
Level of consensus +++
Women should be directly addressed to see how they are coping psychologically with
their pregnancy loss and should be actively offered support.
Consensus-based recommendation 8.E121
Expert consensus
Level of consensus +++
To provide positive support during the grieving process, the patient should be advised
with empathy. The advice should be adapted to the specific situation and should be
unbiased so that the patient is able to make a decision afterwards about her further
treatment together with the doctors treating her.
Consensus-based recommendation 8.E122
Expert consensus
Level of consensus +++
The information, education, support, and medical care provided to vulnerable patients
requires particular sensitivity and professionality. The patient should be informed
about the available non-medical support, if necessary, in cooperation with professionals
working in other specialized medical areas.
Consensus-based recommendation 8.E123
Expert consensus
Level of consensus +++
Women with an early loss of pregnancy and, if necessary, their partner should be advised
that as with other serious life events, they may experience a wide range of grief
responses and feelings of loss and guilt, which are not initially a sign of a mental
disorder.
Consensus-based recommendation 8.E124
Expert consensus
Level of consensus +++
The medical staff involved in the care and treatment of women with early loss of pregnancy
should respond supportively and empathetically to the emotional reactions of women
who have experienced an early loss of pregnancy.
Consensus-based recommendation 8.E125
Expert consensus
Level of consensus +++
After an early loss of pregnancy, women and, if necessary, their partner should be
encouraged to seek support from suitable persons in their social community.
Consensus-based recommendation 8.E126
Expert consensus
Level of consensus +++
After an early loss of pregnancy, women with the above-mentioned risk factors or clearly
suffering from psychological stress should be provided with information about follow-up
care services and psychological counseling.
Consensus-based recommendation 8.E127
Expert consensus
Level of consensus +++
After an early pregnancy loss, women with known psychological problems should be asked
whether they wish to have psychotherapeutic or psychiatric support and whether they
will be able to address possible problems related to the pregnancy loss in therapy.
If necessary, they should be informed about specific (additional) support services.
Consensus-based statement 8.S19
Expert consensus
Level of consensus +++
From about six weeks after the early loss of pregnancy, the physician may assess the
patient for depressive symptoms, e.g., using the two-question Patient Health Questionnaire
(PHQ-2).
Consensus-based recommendation 8.E128
Expert consensus
Level of consensus +++
Women who report relevant psychological symptoms more than two months after the pregnancy
loss should be advised to have a psychiatric assessment and treatment, if necessary.
Consensus-based recommendation 8.E129
Expert consensus
Level of consensus +++
Following an early pregnancy loss, both partners should be asked about their mental
stress to reduce the possible negative impact on their partnership and sexuality.
The detailed list of references is available in the German-language long version of
the guideline.
