Prenatal Exercise Including Perineal Massage and Maternal-Neonatal Outcomes

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.

Conditions

• Postpartum Urinary Incontinence
• Postpartum Depression (PPD)
• Neonatal Complications
• Gestational Diabetes

Interventions

OTHER

Supervised prenatal exercise including antenatal perineal massage

Following random allocation, pregnant participants will participate in supervised prenatal exercise sessions three times weekly, with each session lasting 60 minutes. From 36 weeks' gestation onward, antenatal perineal massage will be administered by trained healthcare professionals at the hospital.

Sponsors & Collaborators

• Guangdong Provincial Maternal and Child Health Hospital

  collaborator OTHER

• Technical University of Madrid

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• South China Normal University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2029-06-30

Completion

2029-12-31

Countries

• China

Study Locations