Clinical trial NCT05854888: Perineal Massage and Warm Compresses - RCT for Reduce Perineal Trauma During Labor
Official title: Perineal Massage and Warm Compresses During Second Stage of Labor - Randomised Controlled Trial for Reduce Perineal Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perineal Tear Resulting From Childbirth
Keywords: Perineum
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study was a single-centre, prospective, randomized controlled trial. Eligibility and informed consent to participate were checked once the woman was in established labor. All participants signed an informed consent form and received a copy wherein the study was described in detail.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). The participants could adopt the birth position they preferred.
Primary purpose: PREVENTION

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Multiple pregnancy
* Meconial amniotic fluid
* Fetal distress
* Suspicion of fetal growth restriction
* Gestational hypertensive disorders

Primary outcomes:
measure: Intact Perineum
timeFrame: up to 10 minutes after childbirth
measure: First-degree perineal tear
timeFrame: up to 10 minutes after childbirth
measure: Second-degree perineal tear
timeFrame: up to 10 minutes after childbirth
measure: OASIS
timeFrame: up to 10 minutes after childbirth
measure: OASIS + episiotomy
timeFrame: up to 10 minutes after childbirth
measure: Episiotomy
timeFrame: up to 10 minutes after childbirth
measure: Episiotomy and first degree tear
timeFrame: up to 10 minutes after childbirth
measure: Episiotomy and second degree tear
timeFrame: up to 10 minutes after childbirth
measure: OASIS with/without episiotomy
timeFrame: up to 10 minutes after childbirth
measure: Vaginal tears
timeFrame: up to 10 minutes after childbirth
measure: Anterior Compartment tears
timeFrame: up to 10 minutes after childbirth
Secondary outcomes:
measure: Admission to Neonatal Intensive Unit Care
timeFrame: up to 2 hours after childbirth
measure: Apgar 5 minutes
timeFrame: 5 minutes after childbirth
measure: Maternal satisfaction with intervention
timeFrame: 24 hours after childbirth
measure: Recommend an intervention allocated to a friend
timeFrame: 24 hours after childbirth
measure: Female Sexual Function Index score
timeFrame: 24 hours, 3 months and 6 months after childbirth
measure: Pelvic Floor Dysfunction symptoms
timeFrame: 24 hours, 3 months and 6 months after childbirth
measure: Maternal Pain
timeFrame: 24 hours, 3 months and 6 months after childbirth
measure: Breastfeeding
timeFrame: 24 hours, 3 months and 6 months after childbirth
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Sílvia Rodrigues
Study officials:
affiliation: Institute Biomedical Sciences Abel Salazar-University of Porto
name: Sílvia Rodrigues, PhD
role: PRINCIPAL_INVESTIGATOR
References: