Characteristics of participants in peripartum interventional research

Abstract

Objective: To identify characteristics of pregnant women potentially influencing the decision to participate in peripartum interventional research.

Methods: Women screened as eligible to participate in two prospective interventional trials conducted in the labor and delivery unit at a single center were included. Characteristics of eligible women were compared based on their decision whether to participate or not. The best predictors of research participation were identified using multivariable logistic regression analyses.

Results: Of the 605 subjects who screened as eligible to participate, 363 (60%) agreed to participate and 242 (40%) declined. Women using a private obstetric provider or who had prior obstetrical complications were less likely to participate [aOR 0.6 (95% CI: 0.4–0.8)] and [aOR 0.6 (95% CI: 0.4–0.9)], respectively. A history of a mental health condition and a higher body mass index (BMI) were marginally more likely to participate [aOR 1.5 (95% CI: 1.0–2.3)] and [aOR 1.03 (95% CI: 1.0–1.1)], respectively. Overall logistic regression model R² was 0.23.

Conclusions: There are differences between eligible subjects who decide to participate or not participate in prospective peripartum interventional research. There is a need to better understand non-participation in order to improve recruitment of representative populations that allow more generalizable research results.

• Informed consent
• perinatal research
• pregnancy
• randomized controlled trial
• research participation

Acknowledgements

We are grateful to Katie Karabasz (research associate) and Jacqueline Grove (medical editor) at LVHN for their assistance with article preparation and editorial comments. We also thank Felisa Saldutti (research scholar) for assistance with data collection.

Declaration of interest

The authors report no conflicts of interest for this research study. No financial support was provided for the conduct of the research reported in this study. However, one of the included studies A randomized controlled trial evaluating safety and efficacy of sodium hyaluronate and carboxymethylcellulose at cesarean delivery received funding from: (1) Investigator-Sponsored Trial Grant, Genzyme Corporation; (2) Winthrop University Hospital PhRMA Foundation Post Doctoral Fellowship in Clinical Outcomes Research Grant; (3) Winthrop University Hospital GCRC Grant #MO1RR10710. This study was presented as a poster at 61st Annual Clinical Meeting, American College of Obstetricians and Gynecologists; 2013 May 7; New Orleans, LA.