The conduct and reporting of randomized controlled trials (RCTs) are enhanced by being compliant with the CONsolidated Standards of Reporting Trials (CONSORT) statement. The statement was meant to be general and was aimed at most RCTs without any particular focus on specific groups of patients. However, research in pregnancy presents important unique issues and challenges that are not addressed in the CONSORT statement. Thus, we suggest that there is a need to amend the statement to address RCTs enrolling pregnant or postpartum women. We propose CONSORT-OB (OBstetrics), with more than 30 modifications to the current statement. We hope the CONSORT group would consider our proposal, and we respectfully suggest that investigators incorporate these additional data into their reporting of RCTs involving pregnant or postpartum women.
Amendments are proposed to the CONsolidated Standards of Reporting Trials (CONSORT) statement aimed at enhancing the design and reporting of randomized clinical trials involving pregnant women.
Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, Virginia; and the Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, UT Health-University of Texas Medical School at Houston, Houston, and the Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas.
Corresponding author: Suneet P. Chauhan, MD, 845 Fairfax Avenue, Suite 544, Norfolk, VA 23507; e-mail: email@example.com.
The authors thank the members of the SMFM Health Policy Committee for critical review of manuscript and important inputs. The members of the committee are Joanne Armstrong, William Grobman, Andrew Helfgott, Dan O'Keeffe, Carolina Reyes, Kathryn Schubert, Cathy Spong, and Sindhu Srinivas.
Financial Disclosure The authors did not report any potential conflicts of interest.