A suggested approach for implementing CONSORT guidelines specific to obstetric research.

Area of Science:

• Obstetrics and Gynecology
• Clinical Trial Methodology
• Evidence-Based Medicine

Background:

• The CONsolidated Standards of Reporting Trials (CONSORT) statement improves randomized controlled trial (RCT) reporting.
• The current CONSORT statement is general and does not address specific challenges in pregnancy research.
• Unique ethical and methodological issues arise in RCTs involving pregnant or postpartum women.

Purpose of the Study:

• To propose amendments to the CONSORT statement for RCTs involving pregnant or postpartum women.
• To introduce CONSORT-OB (OBstetrics), a modified reporting guideline.
• To enhance the quality and completeness of RCT reporting in obstetric research.

Main Methods:

• Review of the existing CONSORT statement.
• Identification of unique issues in pregnancy research not covered by CONSORT.
• Development of over 30 modifications for the CONSORT statement, tailored for obstetric RCTs.

Main Results:

• A proposed checklist, CONSORT-OB, with specific modifications for obstetric RCTs.
• The proposed modifications address unique considerations for pregnant and postpartum populations.
• The revisions aim to improve the reporting of RCTs in this specific demographic.

Conclusions:

• The CONSORT statement requires amendment to adequately address RCTs in pregnant or postpartum women.
• CONSORT-OB offers a tailored framework for reporting obstetric RCTs.
• Investigators are encouraged to adopt these enhanced reporting standards for improved research quality.