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BackgroundAlthough the postpartum period poses substantial risks and can result in significant maternal morbidity and mortality, postpartum care of the mother receives much less attention in transitional countries. ObjectiveWe describe the protocol for a randomized controlled trial to implement and evaluate a postpartum care delivery model titled Focused-PPC (Focused Postpartum Care). MethodsFocused-PPC is an integrated group postpartum care model that meets the clinical care, education, and support needs of mothers up to 1 year after birth. The Focused-PPC intervention is a parallel randomized controlled trial with a total of 192 postpartum women at 4 health centers in Tamale, Ghana. Participants will be randomized into 1 of 2 trial arms at a 1:1 allocation ratio: (1) the control arm, which receives the standard postnatal care currently delivered in health facilities, or (2) the intervention arm, which receives the Focused-PPC model of care. Women enrolled in the intervention arm will receive postpartum clinical assessments and education for the first 6 weeks and will continue to receive education, measures of vital signs, and peer support for 12 months post partum during child welfare visits. Led by trained midwives, each postpartum group in the intervention arm will meet at 1-2 weeks, 6 weeks, and monthly thereafter for up to 1 year post partum, following the Ghana Health Service postnatal care schedule. ResultsThe Focused-PPC guide, data collection tools, and audiovisual education materials were successfully developed and translated into the local language. We have enrolled and conducted baseline surveys for 192 women (sample size met) in the Focused-PPC trial who have been randomized into intervention and control arms. We have established a total of 12 Focused-PPC groups in the intervention arm, 3 groups from each site, all of which have sessions underway. ConclusionsFocused-PPC has the potential to change the postpartum care delivery model in Ghana and other countries in sub-Saharan Africa and beyond. Trial RegistrationClinicalTrials.gov NCT05280951; https://clinicaltrials.gov/study/NCT05280951 International Registered Report Identifier (IRRID)DERR1-10.2196/47519 |
