Abortion in the First Trimester. Guideline of the DGGG (S2k-Level, AWMF Registry No. 015-094, December 2022) – Part 1 with Recommendations on Care Structures, Information and Advice on Decision-Making, Measures Before Abortion and Medical Abortion

Abstract

Purpose The aim was to develop evidence-based recommendations where possible. The guideline presents the medical principles and scientific evidence for indications, the counselling of affected women, performing terminations, the choice of method, and the care and monitoring of a terminated pregnancy up until week 12 + 0 of gestation p. c.

Methods In accordance with the requirements for S2k-guidelines, the contents of the guideline were drafted following a systematic search of the literature by a representative interdisciplinary group of experts. Guideline authors held several formal meetings under the auspices of the German Society for Gynaecology and Obstetrics (DGGG) during which the contents of the guideline were finalised and agreed upon.

Recommendations A total of 61 recommendations are provided, covering care structures, provision of information and counselling to support decision-making, the measures to be taken before terminating the pregnancy, and medical termination of the pregnancy.

Key words

guideline - abortion - medical termination of pregnancy - surgical termination of pregnancy - 1st trimester

I  Guideline Information

Guidelines programme of the DGGG, OEGGG and SGGG

For information on the guidelines programme, please refer to the end of the guideline.

Citation format

Abortion in the First Trimester. Guideline of the DGGG (S2k-Level, AWMF Registry No. 015-094, December 2022) – Part 1 with Recommendations on Care Structures, Information and Advice on Decision-Making, Measures Before Abortion and Medical Abortion. Geburtsh Frauenheilk 2023; 83: 1205–1220

Guideline documents

The complete long version of this guideline in German together with a list of the conflicts of interest of all of the authors is available on the homepage of the AWMF: http://www.awmf.org/leitlinien/detail/ll/015-094.html

Guideline authors

See [Tables 1] and [2].

Table 1 Lead and/or coordinating guideline authors.

Author	AWMF professional society
Prof. Dr. Matthias David	German Society for Gynaecology and Obstetrics [Deutsche Gesellschaft für Gynäkologie und Geburtshilfe] (DGGG)
Prof. Dr. Stephanie Wallwiener	German Society for Psychosomatics in Gynaecology and Obstetrics [Deutsche Gesellschaft für Psychosomatik in Frauenheilkunde und Geburtshilfe] (DGPFG)

Table 2 Participating guideline authors.

Author Mandate holder	DGGG working group (AG)/ AWMF/non-AWMF professional society/ organisation/association
Anne Achtenhagen	Federal Association donum vitae for the Promotion of the Protection of Human Life [Bundesverband donum vitae zur Förderung des Schutzes des menschlichen Lebens]
Prof. Dr. Christian Bamberg	German Society for Ultrasound in Medicine [Deutsche Gesellschaft für Ultraschall in der Medizin]
Dr. Cornelia Bormann	Gynaecological Endoscopy Working Group [Arbeitsgemeinschaft Gynäkologische Endoskopie]
Prof. Dr. Matthias David	German Society for Gynaecology and Obstetrics
Prof. Dr. Ursula Felderhoff-Müser	German Society for Pediatric and Adolescent Medicine [Deutsche Gesellschaft für Kinder- und Jugendmedizin]
Sylvia Groth	Working Group on Womenʼs Health in Medicine, Psychotherapy and Society [Arbeitskreis Frauengesundheit in Medizin, Psychotherapie und Gesellschaft]
Kristina Hänel	German Society for General and Family Medicine [Deutsche Gesellschaft für Allgemein- und Familienmedizin]
Dr. Klaus König	Federal Association of Gynaecologists [Berufsverband der Frauenärzte]
Prof. Dr. Matthias Korell	German Society for Gynaecological Endocrinology and Reproductive Medicine [Deutsche Gesellschaft für gynäkologische Endokrinologie und Fortpflanzungsmedizin]
Prof. Dr. Susanne Michl	Academy for Ethics in Medicine [Akademie für Ethik in der Medizin]
Prof. Dr. Silke Redler	German Society for Human Genetics [Deutsche Gesellschaft für Humangenetik]
Prof. Dr. Ekkehard Schleußner	German Society of Perinatal Medicine [Deutsche Gesellschaft für Perinatalmedizin]
Helga Seyler	Federal Association pro familia – German Society for Family Planning, Sexual Education and Sexual Counselling [Bundesverband pro familia – Deutsche Gesellschaft für Familienplanung, Sexualpädagogik und Sexualberatung]
Prof. Markus Wallwiener	Gynaecological Oncology Working Group [Arbeitsgemeinschaft Gynäkologische Onkologie]
Prof. Stephanie Wallwiener	German Society for Psychosomatics in Gynaecology and Obstetrics

The following professional societies/working groups/organisations/associations stated that they wished to contribute to the guideline text and participate in the consensus conference and nominated representatives to attend the conference ([Table 2]).

The guideline was moderated by Dr. Monika Nothacker (AWMF-certified guidelines adviser/moderator).

Abbreviations

AWMF: Association of the Scientific Medical Societies in Germany [Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften]

β-hCG: beta-human chorionic gonadotropin

NIH: National Institutes of Health

NSAID: non-steroidal anti-inflammatory drug

NIPT-RhD: non-invasive prenatal testing for foetal rhesus D status

p. c.: post conception

SchKG: Law on the Prevention and Management of Pregnancy Conflicts

StGB: (German) Criminal Code [Strafgesetzbuch]

WHO: World Health Organisation

II  Guideline Application

Purpose and objectives

The aim of this guideline is to present the medical principles and scientific evidence for methods, indications, counselling of affected women, performing terminations, choice of method, and the care and monitoring of a termination of pregnancy up until week 12 + 0 of gestation p. c.

Targeted areas of care

• Inpatient care sector, and

• outpatient care sector

Target user groups/target audience

This guideline is aimed at the following groups of people:

• Gynaecologists in private practice

• Hospital-based gynaecologists

• Other physicians involved in abortion counselling and carrying out terminations of pregnancy

• Staff in counselling centres in accordance with § 218/219 StGB

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, organisations, and associations and the board of the DGGG and the DGGG Guidelines Commission as well as by the boards of the SGGG and OEGGG in November 2022 and was thereby approved in its entirety.

This guideline is valid from 26 January 2023 through to 25 January 2026. Because of the contents of this guideline, this period of validity is only an estimate. The publication of new information or changes to care needs may require the guideline to be updated earlier (see next chapter).

III  Methodology

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 the two approaches.

This guideline was classified 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 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-based conferences (S2k/S3 level), authorised participants attending the session vote on draft statements and recommendations. The process is basically 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 extent 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 – 95% of participants agree
+	Majority agreement	> 50 – 75% of participants agree
–	No consensus	< 51% of participants agree

Expert consensus

As the term indicates, this refers to consensus decisions taken 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

Introduction

In principle, pregnancies can be terminated using medication or surgery. Which method is best in each individual case should be decided in an open-ended and unbiased discussion with the pregnant woman.

This guideline was compiled in accordance with the regulations of the AWMF (Association of the Scientific Medical Societies in Germany). In accordance with the requirements for S2k-guidelines, the contents of this guideline, based on a systematic search of the literature, were formally agreed upon by a representative interdisciplinary group of experts.

Details on the methodological approach are available in the guidelines report.

This guideline is mainly aimed at physicians who perform abortions and the professionals involved in the care and counselling of women who wish to have an abortion.

It also aims to support women seeking advice, persons working in counselling centres as defined in § 218/219 StGB and patients and their families.

The following recommendations address care structures, provision of information and counselling to support decision-making, the measures required before terminating the pregnancy, and termination of the pregnancy using medication.

Care structures

Consensus-based recommendation 2.E1
Expert consensus	Level of consensus ++
If the woman has taken the decision to abort the pregnancy, the pregnancy should be terminated as soon as possible, as termination in the early weeks of pregnancy is associated with the lowest complication rates.

Consensus-based recommendation 2.E2
Expert consensus	Level of consensus ++
Physicians and the staff in counselling centres should be familiar with all methods and approaches (surgical, medication, telemedicine, home administration, different analgesia options) and should support the pregnant womanʼs freedom of choice to access her method of choice promptly and at a location close to her place of residence.

Consensus-based recommendation 2.E3
Expert consensus	Level of consensus +++
Administrative processes should be transparent as this will make it easy for affected women to orient themselves and cope with the situation.

Consensus-based recommendation 2.E4
Expert consensus	Level of consensus ++
Pregnant women must be provided with comprehensible, evidence-based and non-directive information and decision-making aids which were developed for this specific target group and are available in different media formats.

Consensus-based recommendation 2.E5
Expert consensus	Level of consensus ++
All procedures and methods including any required medications should be available to ensure equal access.

Consensus-based recommendation 2.E6
Expert consensus	Level of consensus ++
To facilitate acceptability, both physicians and the staff in counselling centres should respect the womanʼs autonomous decision and her dignity, protect her privacy, ensure confidentiality and reduce stigma, set their personal convictions aside, and not delay access.

Consensus-based recommendation 2.E7
Expert consensus	Level of consensus ++
Conveying practical and explanatory knowledge (medical, systematic, ethical, legal, historical, communicative, and socio-cultural) about terminating a pregnancy should be incorporated into and implemented as part of the core medical training curriculum.

Consensus-based recommendation 2.E8
Expert consensus	Level of consensus +++
Existing quality assurance instruments should be used to ensure that quality of care is transparent.

Information and counselling to aid decision-making

Consensus-based recommendation 3.E9
Expert consensus	Level of consensus +++
Women who are considering whether to have an abortion must be offered evidence-based information and support early on which will enable them to make an informed, self-determined decision.

Consensus-based recommendation 3.E10
Expert consensus	Level of consensus +++
Pregnant women must receive all legal information which applies to them.

Consensus-based recommendation 3.E11
Expert consensus	Level of consensus ++
Delays during the process of obtaining an abortion which are caused by the right enshrined in § 12 SchKG to refuse to participate in an abortion should be avoided. In such an event, the pregnant woman should be referred on without delay.

Consensus-based recommendation 3.E12
Expert consensus	Level of consensus +++
All communications with the pregnant woman should be characterised by a respectful treatment of her needs and resources, ensure her confidentiality, allow for sufficient time and show an unprejudiced, non-judgemental attitude on the part of the professionals with regard to the affected womanʼs decision.

Consensus-based recommendation 3.E13
Expert consensus	Level of consensus +++
Information about processes, timeframes and the agencies involved – the different providers, counselling services and offers of support – must be provided as quickly as possible and in such a way that the woman is able to find her way around the healthcare system, use the healthcare options available to her and take the steps required to either terminate or continue with the pregnancy.

Consensus-based recommendation 3.E14
Expert consensus	Level of consensus ++
Professionals should know about existing multimodal sources of information and be able to provide them tailored to the pregnant womanʼs specific needs.

Consensus-based recommendation 3.E15
Expert consensus	Level of consensus ++
Comprehensible, evidence-based information in different formats and counselling must boost the knowledge and health competence of pregnant women in such a way that they are well informed when they make the decision for or against terminating the pregnancy.

Consensus-based recommendation 3.E16
Expert consensus	Level of consensus +++
Women should be encouraged to seek support if required, both private and professional.

Consensus-based recommendation 3.E17
Expert consensus	Level of consensus +++
Information on the methods, procedures, pain and bleeding, behaviour after termination of pregnancy, sexuality and contraception, and actions in an emergency and in the event of complications must be provided.

Consensus-based recommendation 3.E18
Expert consensus	Level of consensus +++
Patients with special requirements and needs must be cared for sensitively and professionally in cooperation with other specialist medical fields where necessary.

Measures prior to the abortion

Consensus-based recommendation 4.E19
Expert consensus	Level of consensus ++
Before an abortion is carried out, the pregnancy must be confirmed by a doctor.

Consensus-based recommendation 4.E20
Expert consensus	Level of consensus ++
Ultrasound examination to determine the week of gestation must be carried out, particularly if the patientʼs menstrual cycle is irregular, the first day of the last menstruation is not certain or the palpated size of the uterus does not correspond to the calculated week of gestation.

Consensus-based recommendation 4.E21
Expert consensus	Level of consensus ++
Abnormalities found on ultrasound images and/or during genetic screening examinations may strongly unsettle pregnant women. Affected pregnant women must be informed about the possibility of false-positive screening results when they are informed about screening or ultrasound findings, and the women must be offered appropriate diagnostic investigations by specialists for prenatal diagnosis.

Consensus-based recommendation 4.E22
Expert consensus	Level of consensus +++
The pregnancy must be confirmed by at least one positive urine β-hCG test. The quantitative determination of β-hCG levels is unsuitable for determining the gestational age of the pregnancy and should therefore not be carried out with this aim in mind.

Consensus-based recommendation 4.E23
Expert consensus	Level of consensus +++
Rhesus-negative women who terminate a pregnancy before week 9 + 0 of gestation should receive anti-D prophylaxis.

Consensus-based recommendation 4.E24
Expert consensus	Level of consensus ++
After termination of a singleton pregnancy, rhesus D-negative women with anti-D antibodies and women for whom the non-invasive prenatal test to determine foetal rhesus factor (NIPT-RhD) in maternal blood showed a negative rhesus factor from week 11 + 0 of gestation must not be injected with anti-D immunoglobulins.

Consensus-based recommendation 4.E25
Expert consensus	Level of consensus ++
Assessment of laboratory results, e.g., haemoglobin levels, should be informed by the patientʼs medical history.

Consensus-based recommendation 4.E26
Expert consensus	Level of consensus +++
Before administering the medication for a medical termination of pregnancy, women may be screened for infection with chlamydia.

Consensus-based recommendation 4.E27
Expert consensus	Level of consensus ++
Previous illnesses and especially psychosocial circumstances should be taken into account when informing the patient about her individual risk and describing the methods used, as this will allow the pregnant woman to make an informed decision.

Consensus-based recommendation 4.E28
Expert consensus	Level of consensus +++
Women must be informed that abortion is a safe medical procedure and serious complications are rare.

Consensus-based recommendation 4.E29
Expert consensus	Level of consensus +++
Women must be informed that in the event of serious complications such as severe blood loss or injury to the uterus or cervix, it may be necessary for the woman to be admitted as an inpatient and she may require a blood transfusion, laparoscopy or laparotomy.

Consensus-based recommendation 4.E30
Expert consensus	Level of consensus +++
Women must be informed that, in rare cases, the pregnancy may persist or remnants of pregnancy tissue may remain, making it necessary to carry out a second procedure.

Consensus-based recommendation 4.E31
Expert consensus	Level of consensus +++
Women must be informed that a medical examination and, if necessary, further medical treatment will be necessary if they develop a fever or symptoms of disease.

Consensus-based recommendation 4.E32
Expert consensus	Level of consensus ++
Women must be informed that the risks of fertility disorders, preterm birth and miscarriage, ectopic pregnancy, and placenta praevia are probably not higher following termination of pregnancy in the first trimester.

Consensus-based recommendation 4.E33
Expert consensus	Level of consensus +++
Patients should be encouraged to arrive at their informed decision by drawing on their own values, preferences, and personal circumstances and considering what is important to them.

Consensus-based recommendation 4.E34
Expert consensus	Level of consensus +++
Physicians should present the possible benefits and possible risks and consequences of each method (communication of risks) used to terminate the pregnancy to the woman, including how they relate to the womanʼs personal circumstances, and should describe them comprehensibly and evidence-based.

Medical abortion

Consensus-based recommendation 5.E35
Expert consensus	Level of consensus ++
Whereas mifepristone can be taken without supervision, patients must be given the choice whether they wish to take the prostaglandin in an institution such as a hospital or doctorʼs surgery or at home.

Consensus-based recommendation 5.E36
Expert consensus	Level of consensus ++
A medical abortion may be additionally supported by telemedicine.

Consensus-based recommendation 5.E37
Expert consensus	Level of consensus ++
Patients must be able to make an informed decision after receiving detailed information about the different approaches.

Consensus-based recommendation 5.E38
Expert consensus	Level of consensus ++
The patient must be provided with written documentation of the findings and treatment as well as an emergency telephone number.

Consensus-based recommendation 5.E39
Expert consensus	Level of consensus ++
A medical abortion may also be performed in minors.

Consensus-based recommendation 5.E40
Expert consensus	Level of consensus ++
With medical abortions, restrictions on the use and the specific health risks associated with taking the medication should be observed.

Consensus-based recommendation 5.E41
Expert consensus	Level of consensus ++
Antibiotic prophylaxis should not be routinely carried out with medical abortion.

Consensus-based recommendation 5.E42
Expert consensus	Level of consensus ++
In principle, doxycycline, metronidazole, and β-lactam antibiotics such as cephalosporins are suitable for antibiotic prophylaxis to reduce the risk of infection after a medical abortion; these active agents should therefore be used in cases with a high risk of infection.

Consensus-based recommendation 5.E43
Expert consensus	Level of consensus +++
A cervical smear should be taken for further examination in women with a relevant risk of or suspected sexually transmissible infection before carrying out the medical abortion.

Consensus-based recommendation 5.E44
Expert consensus	Level of consensus ++
A combination of 200 mg mifepristone and 800 µg misoprostol administered buccally, sublingually, or vaginally 24 to 48 hours later should be administered up until the week 9 + 0 of gestation to obtain a medical abortion.

Consensus-based recommendation 5.E45
Expert consensus	Level of consensus ++
Alternatively, 600 mg mifepristone and 400 µg misoprostol may be administered buccally, sublingually, or vaginally 24 to 48 hours later up until week 7 + 0 of gestation or 800 µg misoprostol vaginally in weeks 7 + 1 to 9 + 0 of gestation.

Consensus-based recommendation 5.E46
Expert consensus	Level of consensus ++
Before a medical abortion, women must be informed that, from week 7 + 1 of gestation, the use of misoprostol in combination with mifepristone is an off-label use.

Consensus-based recommendation 5.E47
Expert consensus	Level of consensus +++
A second dose of 400 µg misoprostol may be administered if bleeding has not commenced three hours after taking misoprostol.

Consensus-based recommendation 5.E48
Expert consensus	Level of consensus +++
Taking an NSAID such as ibuprofen and an antiemetic immediately after taking misoprostol should be recommended to control symptoms better.

Consensus-based recommendation 5.E49
Expert consensus	Level of consensus +++
Pain must be adequately managed. Non-steroidal antiphlogistic agents are suitable for pain management. Oral metamizole may be prescribed. Paracetamol should not be used because of its limited efficacy.

Consensus-based recommendation 5.E50
Expert consensus	Level of consensus +++
According to the WHO analgesic ladder for adequate pain relief, affected women may be provided with a weak opioid such as tramadol.

Consensus-based recommendation 5.E51
Expert consensus	Level of consensus +++
An antiemetic such as dimenhydrinate, metoclopramide or ondansetron should be offered because nausea and vomiting are common after taking misoprostol.

Consensus-based recommendation 5.E52
Expert consensus	Level of consensus +++
Vacuum aspiration must be carried out immediately if severe vaginal or uterine bleeding occurs during a medical abortion.

Consensus-based recommendation 5.E53
Expert consensus	Level of consensus +++
Antibiotic therapy must be started immediately if there are any signs of infection.

Consensus-based recommendation 5.E54
Expert consensus	Level of consensus +++
Intrauterine tissue remnants may be treated with expectant management, administration of a prostaglandin, or vacuum aspiration.

Consensus-based recommendation 5.E55
Expert consensus	Level of consensus +++
If the pregnancy persists, the patient must be informed about the therapeutic options “administering prostaglandins” and “vacuum aspiration” and must be offered a choice of these methods to terminate the pregnancy.

Consensus-based recommendation 5.E56
Expert consensus	Level of consensus +++
Any suspicion of an ectopic pregnancy must be investigated using additional diagnostic measures.

Consensus-based recommendation 5.E57
Expert consensus	Level of consensus +++
After a medical abortion, the woman must be examined properly to ascertain whether the pregnancy has been terminated.

Consensus-based recommendation 5.E58
Expert consensus	Level of consensus ++
Women must be able to choose between different follow-up examination options after they have been informed about the respective benefits and disadvantages.

Consensus-based recommendation 5.E59
Expert consensus	Level of consensus ++
Ultrasound control examination may be offered to women around 2 weeks after commencement of bleeding. However, endometrial thickness alone should not be a criterion to carry out a further intervention if the woman has no symptoms.

Consensus-based recommendation 5.E60
Expert consensus	Level of consensus ++
If the medical follow-up examination is carried out by telemedicine, the termination of the pregnancy must be ascertained by the affected woman carrying out a pregnancy test about 2 weeks after commencement of bleeding. The pregnancy test must have a sensitivity of 1000 IU/l. If subjective symptoms of pregnancy persist or the 1000 IU/l test is positive, the woman should be investigated either by ultrasound examination or by serial determination of β-hCG levels.

Consensus-based recommendation 5.E61
Expert consensus	Level of consensus ++
Serial measurement of serum hCG levels at the time of taking mifepristone and one week later may be carried out to definitively exclude the possibility of a persistent intrauterine or ectopic pregnancy.

A detailed list of references is available in the long German-language version of the guideline.

Conflict of Interest/Interessenkonflikt

The conflicts of interest of all the authors are listed in the long German-language version of the guideline./Die Interessenkonflikte der Autorinnen und Autoren sind in der Langfassung der Leitlinie aufgelistet.

Publikationsverlauf

Eingereicht: 11. April 2023

Angenommen: 14. April 2023

Artikel online veröffentlicht:
05. Oktober 2023