Implementation challenges and outcomes of a randomized controlled pilot study of a group prenatal care model in Malawi and Tanzania.

Abstract

To identify implementation challenges associated with conducting a randomized controlled trial (RCT) of group prenatal care (PNC) and report outcomes of the pilot. A multi-site randomized pilot was conducted in Malawi and Tanzania between July 31, 2014, and June 30, 2015. Women aged at least 16years with a pregnancy of 20-24weeks were randomly assigned using sealed envelopes (1:1) to individual or group PNC. Structured interviews were conducted at baseline, in the third trimester and 6-8weeks after delivery. The primary outcomes were attendance at four PNC visits and attendance at the 6-week postnatal visit. The pilot showed that an RCT with individual randomization can be conducted in these two low-resource settings. Significantly more women in group PNC than in individual PNC completed at least four PNC visits (96/102 [94.1%] vs 53/91 [58.2%]) and attended the postnatal visit (76/102 [74.5%] vs 45/90 [50.0%]; both P<0.001). Group PNC was feasible and associated with an increase in healthcare utilization and improved outcomes in Malawi and Tanzania. Lessons learned should be considered when designing large RCTs to determine efficacy. ClinicalTrials.gov: NCT02999334.