Efficacy of Antenatal Perineal Massage in Reducing Postpartum Morbidities

November 12, 2024 updated by: Rajavithi Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Phaya Thai, Bangkok, Thailand, 10400
        • Rajavithi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antenatal perineal massage
daily 5-minute perineal massage from the 34th or 35th week of pregnancy until delivery
Other: Antenatal perineal massage
Participants at 34-35 weeks of gestation were received training in self-perineal massage and performed a daily 5-minute massage using water-based jelly until delivery to compare with standard obstetric care on postpartum morbidities
No Intervention: Control
standard antenatal, intrapartum and postpartum care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anal incontinence
Time Frame: 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)
At 3 months post-delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary incontinence
Time Frame: 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)
At 3 months post-delivery
Dyspareunia
Time Frame: At 3 months post-delivery
To compare dyspareunia between intervention group and control group. Assessed via the verbal numerical rating scale
At 3 months post-delivery
Postpartum pain
Time Frame: At 24 hours post-delivery
To compare postpartum pain between intervention group and control group. Assessed via the verbal numerical rating scale
At 24 hours post-delivery
Duration of each labor stage
Time Frame: During delivery
To compare duration of first, second and third stage of labor stage between intervention group and control group.
During delivery
Perineal tears and their degrees
Time Frame: During delivery
To compare perineal tear occurrences and their degrees between intervention group and control group.
During delivery
Episiotomy
Time Frame: During delivery
To compare episiotomy occurrences between intervention group and control group.
During delivery
Apgar scores
Time Frame: During delivery
To compare Apgar scores at 1 and 5 minutes of the newborns between intervention group and control group.
During delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajavithi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

July 30, 2024

Study Registration Dates

First Submitted

December 1, 2023

First Submitted That Met QC Criteria

December 1, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 182/2566

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Incontinence

Clinical Trials on Antenatal perineal massage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe