The WHO antenatal care randomised controlled trial: rationale and study design

Area of Science:

• Global Health
• Obstetrics and Gynecology
• Public Health Interventions

Background:

• Antenatal care (ANC) is crucial for maternal and newborn well-being.
• Developing countries face challenges in implementing effective ANC programs.
• A new, evidence-based ANC program was developed to address these challenges.

Purpose of the Study:

• To evaluate the effectiveness of a new, structured antenatal care (ANC) program.
• To compare maternal and fetal outcomes between the new ANC program and traditional care.
• To assess the cost-effectiveness and satisfaction with the new ANC program.

Main Methods:

• Multicentre randomized controlled trial (cluster randomization) in Argentina, Cuba, Saudi Arabia, and Thailand.
• Involved approximately 24,000 pregnant women over 18 months.
• Primary outcomes: maternal morbidity index and low birthweight; secondary outcomes: other maternal/perinatal indicators, cost-effectiveness, and satisfaction.

Main Results:

• The abstract does not contain specific results, but sets up the trial's methodology and intended outcomes.
• The trial is designed to detect a 10% rate of adverse maternal and fetal outcomes in the control group.
• Aims to provide data on the efficacy of the new ANC program.

Conclusions:

• Randomized controlled trials are feasible and essential for evaluating health-care programs in developing countries.
• Rigorous evaluation should precede the implementation of new health interventions.
• The study provides a framework for assessing the impact of structured ANC on maternal and newborn health.