Article Text

Protocol
Effectiveness of metformin to pregnant women with PCOS to reduce spontaneous abortion and gestational diabetes mellitus: a protocol for an overview of reviews
  1. Darmaris Souza Nassif1,
  2. Bianca Lúcia Januário2,
  3. Bianca Antunes Sousa2,
  4. Lehana Thabane3,4,
  5. Joelcio Francisco Abbade1,5
  1. 1Botucau Medical School - Department of Obstetrics and Gynecology, São Paulo State University - UNESP, Botucatu, São Paulo, Brazil
  2. 2Botucau Medical School, UNESP, Sao Paulo, Brazil
  3. 3Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
  4. 4Biostatistics Unit, St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada
  5. 5Maternal Fetal Medicine Department, Hospital das Clínicas da Faculdade de Medicina de Botucatu, Botucatu, São Paulo, Brazil
  1. Correspondence to Dr Joelcio Francisco Abbade; joelcio.f.abbade{at}unesp.br

Abstract

Introduction Polycystic ovary syndrome (PCOS) is a globally prevalent endocrinological disorder and has been associated with poor pregnancy outcomes, including a higher rate of gestational diabetes and miscarriage. Metformin is among the drugs investigated to improve the prognosis of pregnant women with PCOS.

Objective To conduct an overview of systematic reviews examining the effects of metformin versus placebo or no intervention throughout pregnancy among pregnant women with a preconception PCOS diagnosis to reduce the incidence of miscarriage and gestational diabetes.

Methods and analysis We will perform an overview of systematic reviews by searching Embase, PubMed, Virtual Health Library, Cochrane Central Register of Controlled Trials, Trip Database, Scopus, Web of Science and Cumulative Index to Nursing and Allied Health Literature from inception to 17 August 2023. Language, publication status and year indexed or published filters will not be applied. Two reviewers will independently screen and select papers, assess their quality, evaluate their risk of bias and collect the data. The included reviews will be summarised narratively. The quality and risk of bias of the systematic review and meta-analysis studies included will be assessed using AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews, Second Version) and ROBIS (Risk of Bias in Systematic Reviews), respectively.

Ethics and dissemination This overview of reviews will analyse data from systematic reviews on the use of metformin for prepregnancy diagnosis of PCOS to reduce adverse outcomes. As there will be no primary data collection, a formal ethical analysis is unnecessary. The study outcomes will be submitted to a peer-reviewed journal and presented at conferences.

PROSPERO registration number CRD42023441488.

  • Maternal medicine
  • Reproductive medicine
  • Diabetes in pregnancy
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Twitter @AbbadeJ

  • Contributors DSN, BLJ, BAS and JFA were involved in the conception of the study question. DSN, BLJ, BAS and JFA designed the study methods, inclusion and exclusion criteria, and analysis plans. BLJ and DSN are leading the design of the database search strategies. DSN, BLJ, BAS and JFA wrote the first draft of the manuscript. LT reviewed the methods and the manuscript. All authors contributed to the paper, agreed with its contents and consented to the publication of the article.

  • Funding Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES) granted JFA with a scholarship (CAPES - Print - Finance Process 88887.839580/2023-00).

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.