Background/aims: Recent evidence suggests that there are numerous benefits to scheduling postpartum visits as early as 3 weeks post-delivery. However, findings are not conclusive due to methodological limitations. This report discusses the unique aspects of a randomized controlled trial's (RCT) design, intervention, and strategies to maintain participant retention.
Methods: This study was a four-year, prospective, open-label RCT conducted at the Virginia Commonwealth University Medical Center. Women who recently delivered a healthy, full-term baby vaginally, were randomized to receive a 3-4 or 6-8 weeks postpartum appointment and were followed for 18 months.
Results: A total of 364 women participated in this study. A large proportion of women were retained in the study as demonstrated by the high completion rates at the 18-month follow-up interview (Total sample: 87.6%; 3-4 weeks group: 88.0%; 6-8 weeks group: 87.3%). Similarly, high adherence to the protocol-directed postpartum visit schedule was reported in the overall study sample (79.7%), as well as in the 3-4 (70.5%) and 6-8 (90.0%) week postpartum groups.
Conclusion: The study design offered unique features which ensured excellent participant completion and adherence rates, despite the presence of hard-to-track women who typically do not return for their postpartum visits.
Trial registration: ClinicalTrials.gov NCT03165838.
Keywords: Completion and adherence rates; Postpartum visit attendance; Randomized controlled trial; Shortened time interval; Study design and rationale.
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