Efficacy of Antenatal Perineal Massage in Reducing Postpartum Morbidities

Last updated: November 12, 2024
Sponsor: Rajavithi Hospital
Overall Status: Completed

Phase

N/A

Condition

Urinary Incontinence

Enuresis

Bowel Dysfunction

Treatment

Antenatal perineal massage

Clinical Study ID

NCT06162312
182/2566
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Nulliparous singleton pregnant women older than 18 years at 34 - 35 weeks ofgestation

  • 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

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, Analincontinence, pelvic floor dysfunction, or connective tissue diseases

  • Contraindications to vaginal childbirth, such as placenta previa or Placenta accretaspectrum disorder

  • Birth before arrival

Study Design

Total Participants: 106
Treatment Group(s): 1
Primary Treatment: Antenatal perineal massage
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
July 30, 2024

Study 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

Connect with a study center

  • Rajavithi hospital

    Phaya Thai, Bangkok 10400
    Thailand

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.