Skip to content

Development and Validation of an AI-Generated Digital Intervention to Promote Perineal Massage in Pregnant Women at 34 Weeks Gestation: A Randomized Controlled Trial Evaluating Uptake Rate, Postnatal Perineal and Pelvic Floor Symptoms, and Partner Bonding

Development and Validation of an AI-Generated Digital Intervention to Promote Perineal Massage in Pregnant Women at 34 Weeks Gestation: A Randomized Controlled Trial Evaluating Uptake Rate, Postnatal Perineal and Pelvic Floor Symptoms, and Partner Bonding

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122887
Enrollment
Unknown
Registered
2026-04-20
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postnatal Perineal and Pelvic Floor Symptoms

Interventions

AI-Based Teaching Group :Participants will receive twice per weekly AI-guided instruction on perineal massage techniques, including digital simulations and partner-assisted demonstrations. Participant
Face-to-Face Teaching Group:Participants will receive conventional in-person instruction from trained midwives at 34 weeks gestation. Sessions will cover technique, benefits, and allow for demonstrati

Sponsors

Prince of Wales Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Nulliparous women aged >= 18 years 2. Singleton pregnancy from 12 weeks of gestation before 28weeks gestation during first antenatal visit at a tertiary hospital 3. Chinese-speaking 4. Willingness to perform perineal massage 5. Partner willing to participate 6. No contraindications for vaginal delivery

Exclusion criteria

Exclusion criteria: 1.Language barrier. 2.Consanguinity. 3.Drug addicts / substance abuse. 4.Multiple pregnancies. 5.Thalassaemia couples. 6.Abnormal fetal conditions in current pregnancy. 7.Medical complications e.g. cardiac or renal diseases, cancer, endocrine disorders, etc. 8.Deformities: Poliomyelitis, Scoliosis, Spondylosis. 9.History of trauma to spine or pelvis. 10.Uterine mass or adnexal cyst noted in current pregnancy. 11.Psychiatric illness / unstable mood / depression. 12.Active sexually transmitted disease e.g. HIV or syphilis etc. 13.Previous 2nd trimester abortion for fetal abnormality. 14.History of abnormal child, e.g. structural abnormalities, such as spina bifida; chromosomal abnormalities, such as Down's syndrome. 15.Past history of intrauterine death (IUD), neonatal death (NND). 16.Past history of gestational hypertension or pre-eclampsia. 17.Past history of molar pregnancy within 1 year.

Design outcomes

Primary

MeasureTime frame
Takeup rate of AI-based education and face-to-face midwife instruction in perineal massage practice with compliance of at least 2 times per week, and 10 minutes each time. The take-up rate is defined as follows: Participants are instructed to begin perineal massage starting from the 34th week of pregnancy, performing the massage twice a week for 10 minutes per session. A completed massage session in a given week is considered one take-up. Since the period from the 34th to the 38th week of gesta;

Secondary

MeasureTime frame
To be assessed the perineal pain will be measured using the Visual Analogue Scale (VAS). To record the wound healing will be assessed on postpartum Day 1 and Day 2 using the REEDA scale, which evaluates five parameters: redness, edema, ecchymosis, discharge, and approximation of wound edges. Marital satisfaction questionnaire and Female Sexual Function Index will assess the marital relationships per discussed. In addition, pelvic floor function will be assessed through validated questionnaires ;

Countries

CHINA

Contacts

Public ContactSIU KA YI

Prince of Wales Hospital

sky806@ha.org.hk+852 9227 8809

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026