Clinical trial NCT06162312: Efficacy of Antenatal Perineal Massage in Reducing Postpartum Morbidities
Official title: Efficacy of Antenatal Perineal Massage in Reducing Postpartum Morbidities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perineum; Injury
Anal Incontinence
Urinary Incontinence
Keywords: antenatal perineal massage
postpartum morbidities
Anal Incontinence
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2023-12-08
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Anal incontinence
timeFrame: At 3 months post-delivery
Secondary outcomes:
measure: Urinary incontinence
timeFrame: At 3 months post-delivery
measure: Dyspareunia
timeFrame: At 3 months post-delivery
measure: Postpartum pain
timeFrame: At 24 hours post-delivery
measure: Duration of each labor stage
timeFrame: During delivery
measure: Perineal tears and their degrees
timeFrame: During delivery
measure: Episiotomy
timeFrame: During delivery
measure: Apgar scores
timeFrame: During delivery
Other outcomes:
Locations:
city: Phaya Thai
country: Thailand
facility: Rajavithi hospital
state: Bangkok
Study officials:
References:
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