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

Abstract

Objective: To identify implementation challenges associated with conducting a randomized controlled trial (RCT) of group prenatal care (PNC) and report outcomes of the pilot.

Methods: A multi-site randomized pilot was conducted in Malawi and Tanzania between July 31, 2014, and June 30, 2015. Women aged at least 16 years with a pregnancy of 20-24 weeks were randomly assigned using sealed envelopes (1:1) to individual or group PNC. Structured interviews were conducted at baseline, in the third trimester and 6-8 weeks after delivery. The primary outcomes were attendance at four PNC visits and attendance at the 6-week postnatal visit.

Results: 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).

Conclusion: 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.

Keywords: CenteringPregnancy; Group healthcare models; Group prenatal care; Prenatal care; Quality of care; Respectful care; Sub-Saharan Africa.

Conflict of interest statement

Conflicts of interest

The authors have no conflicts of interest.

© 2017 International Federation of Gynecology and Obstetrics.

Figures

Figure 1

Flow of patients through the study. Abbreviation: PNC, prenatal care.

Figure 2

Proportion of women who attended at least four PNC visits. Error bars illustrate 95% CIs. Abbreviations: PNC, prenatal care; OR, odds ratio; CI, confidence interval.

Figure 3

Proportion of women who attended a 6-week postnatal visit. Error bars illustrate 95% CIs. Abbreviations: OR, odds ratio; CI, confidence interval; PNC, prenatal care.