Enhancing the Implementation of a high-quality randomized trial in pregnancy

Area of Science:

• Obstetrics and Gynecology
• Clinical Trials Methodology
• Nutritional Science

Background:

• Pregnancy-related health issues necessitate clinical trials, but conducting them in pregnant populations is challenging.
• Hypovitaminosis D is prevalent in pregnant women, particularly in the Middle East and North Africa (MENA) region.
• Vitamin D supplementation is a potential therapeutic strategy, but its efficacy in pregnancy requires robust clinical trial data.

Purpose of the Study:

• To describe the experience of conducting a randomized controlled trial (RCT) on vitamin D supplementation in pregnant women in Lebanon.
• To outline challenges encountered during trial implementation and strategies employed to overcome them.
• To detail methods used to ensure the internal and external validity of the trial.

Main Methods:

• A double-blind randomized controlled trial (RCT) involving pregnant women from two centers in Lebanon.
• Descriptive data analysis of trial implementation, including recruitment, adherence, and dropout rates.
• Strategies to enhance external validity (e.g., diverse recruitment) and internal validity (e.g., randomization, standardized assessments, risk-of-bias evaluation).

Main Results:

• Sixty percent of screened pregnant women enrolled, with high adherence (>90%) to the intervention.
• Major challenges included recruitment difficulties (35% declined) and differential dropout rates between centers (12% vs. 7%).
• Barriers also included low acceptability of neonatal bone mass scans and variability in fetal measurements.

Conclusions:

• Clinical trials in pregnancy demand culturally sensitive recruitment, strong physician engagement, and robust participant relationships.
• Participant-centered approaches are crucial for improving adherence, minimizing bias, and strengthening both internal and external validity.
• Effective strategies are essential for successful RCTs in pregnant populations, particularly concerning vitamin D supplementation.