Prenatal Exercise Including Perineal Massage and Maternal-Neonatal Outcomes

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Edinburgh Postnatal Depression Scale (EPDS) or Patient Health Questionnaire-9 (PHQ-9) total score — Baseline (after randomization); 28 and 36 weeks' gestation; and 1, 2, 4, 6, 8, 12, 24, 36 months postpartum
  Depressive symptoms score： Depressive symptoms will be assessed using the 1. Edinburgh Postnatal Depression Scale (The scale consists of a total of 10 items, each scored on a four-point Likert scale ranging from 0 to 3, with a maximum total score of 30. A total score greater than 12 is considered a positive screening result, indicating a high likelihood of perinatal depression in pregnant or postpartum women, and professional medical consultation is recommended. Higher total scores indicate more severe depressive symptoms.) ， or 2. Patient Health Questionnaire-9 (The scale consists of 9 items, each of which is scored based on the frequency of symptoms experienced over the past two weeks. Each item is rated on a scale from 0 to 3, resulting in a total score ranging from 0 to 27. Interpretation of total scores: 0-4: No depressive symptoms 5-9: Possible mild depression 10-14: Possible moderate depression 15-19: Possible moderately severe depression 20-27: Possible severe depress).
• Number of participants with urinary incontinence assessed by the International Consultation on Incontinence Questionnaire (ICIQ) — 34 weeks' gestation; and 1, 3, 6, 12, 18, 24, and 36 months postpartum
  Urinary incontinence will be assessed using the International Consultation on Incontinence Questionnaire (In this study, urinary incontinence was defined as experiencing urine leakage at least once per week).
• Number of participants diagnosed with gestational diabetes mellitus (GDM) — 24-28 weeks' gestation (routine screening), at any time during pregnancy (up to 40 weeks of gestation) if clinically indicated.
  GDM will be determined using a 75-g OGTT according to prespecified diagnostic criteria (e.g., IADPSG/WHO-recommended thresholds as adopted by the participating hospitals). The outcome will be reported as the number (and percentage) of participants meeting the diagnostic criteria during pregnancy, extracted from hospital laboratory and medical records.
• Maternal weight (kg) — Pre-pregnancy (self-reported at baseline); early pregnancy (≤13 weeks' gestation); mid-pregnancy (24-28 weeks' gestation); late pregnancy (34-36 weeks' gestation); and 1, 2, 4, 6, 8, 12, 18, 24, and 36 months postpartum
  Maternal weight will be measured in kilograms using standardized clinical assessments and extracted from antenatal and postpartum medical records. Weight will be reported at each prespecified time point and compared between groups.

Trial sites (1)

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