Efficacy of Antenatal Perineal Massage in Reducing Postpartum Morbidities

Not Applicable

Completed

• Conditions: Anal Incontinence; Urinary Incontinence; Perineum; Injury
• Interventions: Other: Antenatal perineal massage

• Registration Number: NCT06162312
• Lead Sponsor: Rajavithi Hospital

Brief Summary

A randomized controlled trial was undertaken at Rajavithi Hospital, Bangkok, Thailand, encompassing 106 primigravidae within the period of December 2023 to June 2024. The intervention group underwent antepartum perineal massage, starting at the 34th - 35th week of gestation and extending until delivery, while the control group did not receive such intervention. The primary outcome evaluated was the incidence of anal incontinence at the 3-month postpartum. Secondary outcomes included the duration of each labor stage, perineal tears and their degrees, episiotomy occurrences, Apgar scores at 1 and 5 minutes, postpartum pain within 24 hours, dyspareunia, and urinary incontinence at the 3-month postpartum.

Detailed Description

Vaginal births often result in perineal trauma, leading to substantial morbidity. This study hypothesized that antenatal perineal massage (APM) could mitigate the incidence of perineal injuries and related postpartum morbidities.

Participants at 34-35 weeks of gestation were randomly assigned by a computer program to either the Antenatal Perineal Massage (APM ) group or the control group. The APM group received training in self-perineal massage and performed a daily 5-minute massage using water-based jelly until delivery, while the control group did not receive such intervention.

The technique involved inserting the thumb finger 3-5 cm into the vagina, using a water-based jelly for lubrication. The procedure included maintaining the thumb steady on the perineum for 1 minute, applying up-and-down pressure for 1 minute, and performing downward and sideways sweeping motions for 3 minutes. Initial massage sessions were conducted under supervision at the antenatal clinic.

Participants were advised to discontinue APM in case of premature rupture of membranes (PROM), bleeding, or infection, seeking prompt hospital management. Additionally, they were instructed to maintain a diary documenting their daily APM sessions.

Both groups received standard antenatal, intrapartum, and postpartum care. Obstetric care providers, investigator and outcomes assessor remained blinded to participants' study group allocations.

During labor at the casualty department, routine care was administered without intervention in labor management or cesarean delivery decisions. Recorded data encompassed the duration of each labor stage, perineal tears and their degrees, episiotomy occurrences, urgency for cesarean section or operative vaginal delivery, infant weight, sex, Apgar scores at 1 and 5 minutes, and postpartum pain using a verbal numerical rating scale within 24 hours.

Participants were followed up at 3 months post-delivery to evaluate the anal incontinence, urinary incontinence (assessed via the validated Thai version of Pelvic Floor Distress Inventory - 20 (PFDI-20)), and dyspareunia (using a verbal numerical rating scale

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12-01
• Study First Submitted: 2023-12-01
• Study First Submitted QC: 2023-12-01
• Study First Posted: 2023-12-08
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-30
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 106

Inclusion Criteria

• Nulliparous singleton pregnant women older than 18 years at 34 - 35 weeks of gestation
• The fetus has a cephalic presentation.
• Proficiency in the Thai language for communication
• Willingness to engage in research projects
• Intending to deliver at Rajavithi Hospital

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Exclusion Criteria

• Genital infections such as herpes or candida vulvovaginitis.
• Previous Caesarean section.
• Pregnant women who underwent epidural anesthesia or required instrumental delivery
• Pregnant women with a history of chronic cough, urinary incontinence, Anal incontinence, pelvic floor dysfunction, or connective tissue diseases
• Contraindications to vaginal childbirth, such as placenta previa or Placenta accreta spectrum disorder
• Birth before arrival

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antenatal perineal massage	Antenatal perineal massage	daily 5-minute perineal massage from the 34th or 35th week of pregnancy until delivery

Primary Outcome Measures

Name	Time	Method
Anal incontinence	At 3 months post-delivery	To compare anal incontinence between intervention group and control group. Assessed via the validated Thai version of Pelvic Floor Distress Inventory - 20 (PFDI-20)

Secondary Outcome Measures

Name	Time	Method
Perineal tears and their degrees	During delivery	To compare perineal tear occurrences and their degrees between intervention group and control group.
Urinary incontinence	At 3 months post-delivery	To compare urinary incontinence between intervention group and control group. Assessed via the validated Thai version of Pelvic Floor Distress Inventory - 20 (PFDI-20)
Duration of each labor stage	During delivery	To compare duration of first, second and third stage of labor stage between intervention group and control group.
Episiotomy	During delivery	To compare episiotomy occurrences between intervention group and control group.
Apgar scores	During delivery	To compare Apgar scores at 1 and 5 minutes of the newborns between intervention group and control group.
Dyspareunia	At 3 months post-delivery	To compare dyspareunia between intervention group and control group. Assessed via the verbal numerical rating scale
Postpartum pain	At 24 hours post-delivery	To compare postpartum pain between intervention group and control group. Assessed via the verbal numerical rating scale

Trial Locations

Locations (1)

Rajavithi hospital; 🇹🇭 Phaya Thai, Bangkok, Thailand