Prenatal Exercise Including Perineal Massage and Maternal-Neonatal Outcomes

NCT07314502 | Not Yet Recruiting DMC

• 1 other identifier: 20250094
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does the combined prenatal program reduce urinary incontinence during pregnancy and after delivery?
2. 2.Does the combined prenatal program reduce depressive symptoms during pregnancy and in the postpartum period?
3. 3.Does the combined prenatal program lower the risk of gestational diabetes mellitus?
4. 4.Does the combined prenatal program reduce neonatal complications, including macrosomia?
5. 5.Do spontaneous, self-initiated prenatal exercise and structured, supervised prenatal exercise differ in their effects on maternal and neonatal outcomes ()?
6. 6.Be screened and enrolled during pregnancy and complete baseline and follow-up assessments during pregnancy and after delivery.
7. 7.Be randomly assigned to either an intervention group or a usual-care control group.
8. 8.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.
9. 9.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

Keywords

Exercise; Urinary Incontinence; Postpartum Depression; Macrosomia; Pregnancy

Outcome Measures

Primary Outcomes (4)

• Edinburgh Postnatal Depression Scale (EPDS) or Patient Health Questionnaire-9 (PHQ-9) total score

  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).

  Baseline (after randomization); 28 and 36 weeks' gestation; and 1, 2, 4, 6, 8, 12, 24, 36 months postpartum

• Number of participants with urinary incontinence assessed by the International Consultation on Incontinence Questionnaire (ICIQ)

  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).

  34 weeks' gestation; and 1, 3, 6, 12, 18, 24, and 36 months postpartum

• Number of participants diagnosed with gestational diabetes mellitus (GDM)

  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.

  24-28 weeks' gestation (routine screening), at any time during pregnancy (up to 40 weeks of gestation) if clinically indicated.

• Maternal weight (kg)

  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.

  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

Secondary Outcomes (6)

• Mode of delivery (vaginal, operative vaginal, or cesarean)

  At delivery (36-40 weeks' gestation)

• Episiotomy rate at delivery

  At delivery (36-40 weeks' gestation)

• Perineal tear severity (first- to fourth-degree) at delivery

  At delivery (36-40 weeks' gestation)

• Duration of labor from active phase onset to delivery (hours)

  At delivery (36-40 weeks' gestation)

• birth weight and early childhood weight

  At birth, and 1, 2, 4, 6, 8, 12, 18, 24, and 36 months of age

Study Arms (2)

Exercise group

EXPERIMENTAL

Participants will receive routine prenatal care and a supervised prenatal exercise throughout pregnancy including perineal massage at late pregnancy.

Other: Supervised prenatal exercise including antenatal perineal massage

Control

NO INTERVENTION

Participants will receive routine prenatal care and will not receive the structured supervised exercise program or professionally administered antenatal perineal massage

Interventions

Supervised prenatal exercise including antenatal perineal massage OTHER

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.

Exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years；
• Gestational age between 8 and 16 weeks
• No contraindications to exercise；
• Able to attend in-person exercise classes；
• Having obtained hospital approval to participate in this exercise program；
• Able to carry out basic communication in Mandarin Chinese;
• Planning to deliver at the same maternal and child health hospital.

You may not qualify if:

• Unable to deliver at the same hospital due to personal reasons；
• Currently participating in other research projects；
• Presence of absolute contraindications to exercise；
• Uncertain about being able to attend three in-person exercise sessions per week；
• Unable to communicate in Mandarin Chinese.

Sponsors & Collaborators

• South China Normal University: lead
• Guangdong Provincial Maternal and Child Health Hospital: collaborator
• Technical University of Madrid: collaborator
• University of Alberta: collaborator

Study Sites (1)

South China Normal University

Guangzhou, China

Location

Related Links

• Brik M, Sánchez-Polán M, Farràs A, Hernández-Fleury A, Temprado J, Calero I, Higueras T, Silva C, Zhang D, Carreras E, Barakat R. Maternal and cardiovascular factors related to carotid intima-media thickness during pregnancy: A prospective cohort study.
• Sánchez-Polán M, Brik M, Silva-Jose C, Zhang D, Díaz-Blanco MÁ, de la Manzanara PH, Arias AM, Alzola I, Barakat R. Physical activity during pregnancy and depression, anxiety and stress: randomized clinical trials. American Journal of Obstetrics \& Gynecol
• Zhang D, Sánchez-Polán M, Silva-Jose C, Díaz-Blanco Á, Brik M, Arias AM, Hernando P, Barakat R. Prenatal Exercise Decreases Urinary Incontinence in Late Pregnancy and 3 Months Postpartum: A Randomized Controlled Trial. Medicine and science in sports and
• Related Info
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MeSH Terms

Conditions

Depression, Postpartum; Diabetes, Gestational; Motor Activity; Urinary Incontinence

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dingfeng Zhang, Dr

CONTACT

+86 18811718556; zhangdingfeng123@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: January 2, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 2, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)