Prenatal Exercise Including Perineal Massage and Maternal-Neonatal Outcomes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Edinburgh Postnatal Depression Scale (EPDS) or Patient Health Questionnaire-9 (PHQ-9) total score
研究概览
简要总结
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:
- Does the combined prenatal program reduce urinary incontinence during pregnancy and after delivery?
- Does the combined prenatal program reduce depressive symptoms during pregnancy and in the postpartum period?
- Does the combined prenatal program lower the risk of gestational diabetes mellitus?
- Does the combined prenatal program reduce neonatal complications, including macrosomia?
- 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:
- Be screened and enrolled during pregnancy and complete baseline and follow-up assessments during pregnancy and after delivery.
- Be randomly assigned to either an intervention group or a usual-care control group.
- 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.
- Provide questionnaire-based information and clinical data collected during routine visits and from medical records for outcome evaluation.
详细描述
This project is conducted in a provincial Maternal and Child Health Hospital network (one leading center plus three collaborating hospitals) and is organized into three phases: (1) a baseline survey, (2) a prospective observational follow-up, and (3) a parallel-group randomized controlled trial (RCT) implemented in routine care.
Overall design and procedures Phase 1 uses a cross-sectional baseline survey (planned n=3,000; Nov 25-Dec 31, 2025) to describe current voluntary participation in prenatal perineal massage. Phase 2 is a prospective follow-up cohort (planned n=2,000; Jan 1, 2026-Jan 31, 2028) tracking participants from the first antenatal visit through 24 months postpartum to evaluate real-world patterns of spontaneous prenatal exercise and voluntary perineal massage and their associations with maternal and neonatal outcomes. Phase 3 is a two-arm, parallel-group RCT (planned n=2,000; Jan 1, 2026-Dec 31, 2028) comparing a structured combined prenatal program versus usual antenatal care, with follow-up extended to 36 months postpartum.
Participants and setting Pregnant women receiving routine antenatal care at participating hospitals will be screened by clinical staff. Eligibility and exclusion criteria are provided in the record's Eligibility section. Written informed consent will be obtained prior to any study-specific procedures.
Randomization and masking (Phase 3) In the RCT, participants will be randomized in a 1:1 ratio using a computer-generated allocation sequence managed centrally by designated staff at the leading center. Allocation concealment procedures will be applied for staff involved in outcome assessment and data management when feasible. Due to the nature of the intervention, participants and intervention staff cannot be blinded; however, outcome assessment and data analysis will be performed with masking whenever operationally feasible.
Intervention (Phase 3) Participants assigned to the intervention group will receive (1) a supervised, moderate-intensity prenatal exercise program and (2) professionally administered antenatal perineal massage during late pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Edinburgh Postnatal Depression Scale (EPDS) or Patient Health Questionnaire-9 (PHQ-9) total score
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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)
- newborn height and head circumference(At birth, and 1, 2, 4, 6, 8, 12, 18, 24, and 36 months of age)
研究者
Dingfeng Zhang
Principal Investigator
South China Normal University