Efficacy of Antenatal Perineal Massage in Reducing Postpartum Morbidities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rajavithi Hospital
- Enrollment
- 106
- Locations
- 2
- Primary Endpoint
- Anal incontinence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Perineal tears and their degrees(During delivery)
- Urinary incontinence(At 3 months post-delivery)
- Duration of each labor stage(During delivery)
- Episiotomy(During delivery)
- Apgar scores(During delivery)
- Dyspareunia(At 3 months post-delivery)
- Postpartum pain(At 24 hours post-delivery)