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.
Age ≥ 18 years；
Gestational age between 8 and 16 weeks
No contraindications to exercise；
Able to attend in-person exercise classes；
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；
Parallel
Supervised prenatal exercise including antenatal perineal massage
Other interventionFollowing 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.
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).
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).
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.
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.
Mode of delivery (vaginal, operative vaginal, or cesarean)
Mode of delivery will be classified based on delivery records as vaginal birth (spontaneous), operative vaginal birth (vacuum or forceps), or cesarean delivery. The outcome will be reported as the number (and percentage) of participants in each category and compared between groups.
Episiotomy rate at delivery
Episiotomy will be recorded from delivery medical records. The outcome will be reported as the number (and percentage) of participants who undergo episiotomy and compared between groups.
Perineal tear severity (first- to fourth-degree) at delivery
Perineal tears will be classified according to standard obstetric definitions (first-, second-, third-, or fourth-degree) based on delivery records. The outcome will be reported as the number (and percentage) of participants in each tear grade and compared between groups.
Duration of labor from active phase onset to delivery (hours)
The duration of labor will be defined as the time from the onset of active labor (cervical dilation ≥ 6 cm with regular uterine contractions) to delivery of the neonate. Time will be extracted from standardized labor and delivery records and reported in hours, then compared between groups.
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South China Normal University
Lead sponsor
Guangdong Provincial Maternal and Child Health Hospital
Collaborator
Technical University of Madrid
Collaborator
University of Alberta
Collaborator
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