Clinical Trial

Prenatal Exercise Including Perineal Massage and Maternal-Neonatal Outcomes

Study acronym: PEPM-RCT
Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
The study is divided into three phases: Phase 1: Baseline survey to obtain an overall understanding of the current situation of voluntary participation in prenatal perineal massage. Phase 2: Follow-up survey to further assess the current situation of voluntary prenatal exercise and prenatal perineal massage. Phase 3: Implementation of an intervention combining prenatal exercise and perineal massage. The goal of this clinical trial is to learn whether a combined prenatal program of supervised, moderate-intensity exercise plus professionally administered antenatal perineal massage can improve maternal and newborn outcomes and can be safely implemented as part of routine antenatal care in healthy pregnant women receiving care at participating hospitals. The main questions it aims to answer are: 1. Does the combined prenatal program reduce urinary incontinence during pregnancy and after delivery? 2. Does the combined prenatal program reduce depressive symptoms during pregnancy and in the postpartum period? 3. Does the combined prenatal program lower the risk of gestational diabetes mellitus? 4. Does the combined prenatal program reduce neonatal complications, including macrosomia? 5. Do spontaneous, self-initiated prenatal exercise and structured, supervised prenatal exercise differ in their effects on maternal and neonatal outcomes ()? Researchers will compare the combined prenatal program to usual antenatal care to determine whether the intervention improves maternal and neonatal outcomes and is safe, feasible, and acceptable in a real-world clinical setting. Participants will: 1. Be screened and enrolled during pregnancy and complete baseline and follow-up assessments during pregnancy and after delivery. 2. Be randomly assigned to either an intervention group or a usual-care control group. 3. If assigned to the intervention group, attend supervised moderate-intensity exercise sessions three times per week (approximately 60 minutes per session) throughout pregnancy and receive antenatal perineal massage delivered by trained health professionals during late pregnancy. 4. Provide questionnaire-based information and clinical data collected during routine visits and from medical records for outcome evaluation.
Trial Details
NCT Number NCT07314502
Lead Sponsor South China Normal University
Collaborators: Guangdong Provincial Maternal and Child Health Hospital, Technical University of Madrid, University of Alberta
Conditions Postpartum Urinary Incontinence, Postpartum Depression (PPD), Neonatal Complications, Gestational Diabetes
Enrollment 2,000 participants
Start Date 2026-01-01
Primary Completion 2029-06-30 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-02