Perineal Massage and Warm Compresses - RCT for Reduce Perineal Trauma During Labor
- Conditions
- Perineal Tear Resulting From Childbirth
- Registration Number
- NCT05854888
- Lead Sponsor
- Universidade do Porto
- Brief Summary
The aim of this study is to evaluate the effect of a combined perineal massage and warm compresses intervention on the perineum integrity during second stage of labor.
- Detailed Description
A single-centre, prospective, randomized controlled trial was conducted. Eligibility and informed consent to participate were checked once the woman was in established labor. Eligible participants were randomized at the second stage of labor. The trial intervention took place during the second stage of the spontaneous vaginal birth. Participants were randomized to one of the two groups, perineal massage and warm compresses on second stage of labor or control group (hands-on).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 800
- Women with 18 years or older
- Between 37 and 41 weeks of pregnancy
- Expected spontaneous vaginal birth
- Fetus in the cephalic presentation
- Able to provide informed written consent
- Multiple pregnancy
- Meconial amniotic fluid
- Fetal distress
- Suspicion of fetal growth restriction
- Gestational hypertensive disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method First-degree perineal tear up to 10 minutes after childbirth Skin and vaginal tear
Intact Perineum up to 10 minutes after childbirth Absence of tissue separation at any site, without vaginal tears or any other degree of perineal trauma)
Second-degree perineal tear up to 10 minutes after childbirth Skin and muscle tear (posterior compartment)
OASIS up to 10 minutes after childbirth Obstetric anal sphincter injuries (Third-degree tears (injury of anal sphincter) and Fourth-degree tears (Injury of anal sphincter and the anal canal or rectum) without episiotomy
OASIS + episiotomy up to 10 minutes after childbirth Third and fourth degree tear with episiotomy
Episiotomy up to 10 minutes after childbirth without spontaneous perineal trauma or vaginal tears
Episiotomy and second degree tear up to 10 minutes after childbirth Episiotomy and spontaneous skin and muscle tear
OASIS with/without episiotomy up to 10 minutes after childbirth with and without episiotomy
Vaginal tears up to 10 minutes after childbirth only vaginal tear
Episiotomy and first degree tear up to 10 minutes after childbirth Episiotomy with spontaneous skin tear
Anterior Compartment tears up to 10 minutes after childbirth Without episiotomy or any other degree of perineal trauma
- Secondary Outcome Measures
Name Time Method Admission to Neonatal Intensive Unit Care up to 2 hours after childbirth Admission to Neonatal Intensive Unit Care
Apgar 5 minutes 5 minutes after childbirth Apgar Score at 5 minutes (0-10) higher scores mean better outcome
Recommend an intervention allocated to a friend 24 hours after childbirth Question about whether women would recommend the intervention they received to a friend
Pelvic Floor Dysfunction symptoms 24 hours, 3 months and 6 months after childbirth Pelvic Floor Distress Inventory (0-300) higher scores mean worse outcome
Maternal satisfaction with intervention 24 hours after childbirth Question about maternal satisfaction with intervention
Female Sexual Function Index score 24 hours, 3 months and 6 months after childbirth Female Sexual Function Index score (2-36) higher scores mean better outcome
Maternal Pain 24 hours, 3 months and 6 months after childbirth Numerical Pain score (0-10) higher scores mean worse outcome
Breastfeeding 24 hours, 3 months and 6 months after childbirth Exclusive breastfeeding
Trial Locations
- Locations (1)
Sílvia Rodrigues
🇵🇹Braga, Portugal
Sílvia Rodrigues🇵🇹Braga, Portugal