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What we have learned about conducting randomized controlled trials in the NICHD MFMU network
Elizabeth A Thom1, Dwight J Rouse,
1The George Washington University, Washington, DC, USA.
Seminars in Perinatology
|August 2, 2003
Summary
The NICHD Maternal Fetal Medicine Units Network improved perinatal care through 16 randomized trials. They addressed challenges like recruitment and feasibility to enhance pregnancy and infant outcomes.
Area of Science:
- Perinatal Medicine
- Clinical Trials
- Maternal-Fetal Health
Background:
- Established in 1986, the NICHD Maternal Fetal Medicine Units Network conducts randomized trials and observational studies.
- The Network aims to enhance adverse pregnancy and infant outcomes.
- Between 1986 and 2002, 16 randomized trials were initiated.
Purpose of the Study:
- To describe five key randomized trials conducted by the Network.
- To highlight and address challenges encountered during trial implementation.
- To detail methodological and organizational adaptations made by the Network.
Main Methods:
- Focus on five specific randomized trials within the Network.
- Analysis of critical issues: feasibility, sample size, randomization in high-risk pregnancies, clinical practice changes, investigator interest, and recruitment.
- Description of organizational and methodological modifications implemented by the Network.
Main Results:
- The Network successfully initiated 16 randomized trials from 1986 to 2002.
- Difficulties in trial conduct were identified and addressed.
- Adaptations in organization and methodology were developed and applied to ongoing and future trials.
Conclusions:
- The Network demonstrated adaptability in overcoming challenges in perinatal clinical trials.
- Methodological and organizational changes enhanced the Network's capacity to conduct impactful research.
- These adaptations contribute to improving pregnancy and infant outcomes through rigorous research.