Outcome of first trimester medical termination of pregnancy: definitions and management

Abstract

Objective: Medical termination of pregnancy (MToP, or medical abortion) is a highly effective method with a reported efficacy of 95–98%. However, different criteria are currently used to define success, and there are different recommendations for the treatment of what is considered a failure of MToP. This work was undertaken to develop a consensus around a set of well-defined MToP outcomes, as recommended by the Core Outcomes in Women’s and Newborn Health initiative.

Methods: A literature search was made of national and international guidelines and of recommendations of expert groups for various outcomes of MToP and subsequent management. Based on a review of the findings, a group of European experts in MToP undertook a consensus process to agree on a set of core MToP outcomes.

Results: The following core MToP outcomes were defined: success, failure (ongoing pregnancy), need for additional treatment (medical or surgical) to complete MToP (missed abortion, incomplete abortion), complications and the woman’s request for additional treatment (medical or surgical). Recommendations for the management of unsuccessful outcomes were also formulated.

Conclusion: New definitions of MToP outcomes that are more focused on objective criteria and consequently less dependent on provider interpretation are proposed. This should allow better comparison of the efficacy of different regimens and improve the management of failed or incomplete abortion.

摘要

目的：药物终止妊娠（MToP或药物流产）是一种非常有效的方法, 报道的有效率为95-98%。然而目前用于定义药物终止妊娠成功的标准不同, 对于MToP治疗失败也有不同的建议。开展这项工作是为了按照妇女和新生儿健康倡议核心成果的建议, 就一系列明确定义MToP达成共识。

方法：查阅国内外关于MToP结局及后续管理的各种指南及专家小组的建议。在对调查结果进行查阅的基础上, 欧洲专家进行了MToP的一组进行了协商一致, 对MToP的一系列结局达成一致。

结果：MToP的核心结局被定义为：成功、失败（持续妊娠）、需要额外治疗（药物或手术）完成MToP（稽留流产、不全流产）, 并发症及妇女要求额外治疗（药物或手术）。对不成功的结果管理也提出了建议。

结论：提出了MToP结局的新定义, 更侧重与客观标准, 因此更少地依赖患者的解释。这样可以更好地比较不同方案的疗效, 并改善失败或不完全流产的管理。

Keywords:

• Incomplete abortion
• medical abortion outcome
• medical termination of pregnancy
• missed abortion
• ongoing pregnancy

Acknowledgements

The authors would like to thank J. Arthur for her help in medical writing.

Disclosure statement

All authors, except for Sharon Cameron, are members of the external scientific advisory board of Exelgyn. Sharon Cameron was a member until 2016 and ceased thereafter; she has no conflict of interest. Christian Fiala has served on an ad hoc basis as an invited lecturer for Exelgyn and Teva. Teresa Bombas is a member of the advisory board of MSD and HRA and a speaker in conferences/symposia organised by Bayer, MSD, HRA, Gedeon and Exelgyn. Mirella Parachini has served on an ad hoc basis as a consultant for Nordic Pharma. Aubert Agostini is a member of the board at MSD and has served as an investigator for a Nordic Pharma study. Roberto Lertxundi has financial relationships (member of advisory boards, lecturer and/or consultant) with Nordic Pharma, Exeltis, Bayer and Teva. Marek Lubusky has no conflict of interest. Laurence Saya is an employee of Altius Pharma, a consultancy and medical writing company, which received funding from Exelgyn for help with this work. Kristina Gemzell-Danielsson serves or has served on an ad hoc basis as an invited lecturer for Exelgyn, Linepharma and Gynuity, and as an investigator in clinical trials conducted by Concept Foundation/SunPharma.

Additional information

Funding

This work was supported by a grant from Exelgyn.