Perineal Massage and Warm Compresses - RCT for Reduce Perineal Trauma During Labor

Perineal Tear Resulting From Childbirth Clinical Trial

— PeMWaC  

Official title:

Perineal Massage and Warm Compresses During Second Stage of Labor - Randomised Controlled Trial for Reduce Perineal Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05854888
• Other study ID #: 201802476
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: May 2023
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: July 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Perineal Tear Resulting From Childbirth

Intervention

Procedure:
• Perineal Massage and Warm Compresses (PeMWaC)
Perineal Massage was performed in the II Hodge Plan, between maternal contractions and regardless of maternal position. Warm Compresses were applied by the midwife between Hodge plans III and IV, during pushing and regardless of maternal position.
• Control Group (Hands-on)
The midwife placed the index, middle, and little fingers of the non-dominant hand together on the child's occiput, with the palm facing the anterior region of the perineum, when the child's head was crowning. In this way, the expulsion was controlled, maintaining the flexion of the head. Simultaneously, the dominant hand was flattened and placed on the posterior region of the perineum, with the index finger and thumb, forming a "U", exerting pressure on the posterior region of the perineum during the crowning process. During the birth of the shoulders and the rest of the body, the dominant hand was kept in place, protecting the posterior region of the perineum.

Locations

Country	Name	City	State
Portugal	Sílvia Rodrigues	Braga

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intact Perineum	Absence of tissue separation at any site, without vaginal tears or any other degree of perineal trauma)	up to 10 minutes after childbirth
Primary	First-degree perineal tear	Skin and vaginal tear	up to 10 minutes after childbirth
Primary	Second-degree perineal tear	Skin and muscle tear (posterior compartment)	up to 10 minutes after childbirth
Primary	OASIS	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	up to 10 minutes after childbirth
Primary	OASIS + episiotomy	Third and fourth degree tear with episiotomy	up to 10 minutes after childbirth
Primary	Episiotomy	without spontaneous perineal trauma or vaginal tears	up to 10 minutes after childbirth
Primary	Episiotomy and first degree tear	Episiotomy with spontaneous skin tear	up to 10 minutes after childbirth
Primary	Episiotomy and second degree tear	Episiotomy and spontaneous skin and muscle tear	up to 10 minutes after childbirth
Primary	OASIS with/without episiotomy	with and without episiotomy	up to 10 minutes after childbirth
Primary	Vaginal tears	only vaginal tear	up to 10 minutes after childbirth
Primary	Anterior Compartment tears	Without episiotomy or any other degree of perineal trauma	up to 10 minutes after childbirth
Secondary	Admission to Neonatal Intensive Unit Care	Admission to Neonatal Intensive Unit Care	up to 2 hours after childbirth
Secondary	Apgar 5 minutes	Apgar Score at 5 minutes (0-10) higher scores mean better outcome	5 minutes after childbirth
Secondary	Maternal satisfaction with intervention	Question about maternal satisfaction with intervention	24 hours after childbirth
Secondary	Recommend an intervention allocated to a friend	Question about whether women would recommend the intervention they received to a friend	24 hours after childbirth
Secondary	Female Sexual Function Index score	Female Sexual Function Index score (2-36) higher scores mean better outcome	24 hours, 3 months and 6 months after childbirth
Secondary	Pelvic Floor Dysfunction symptoms	Pelvic Floor Distress Inventory (0-300) higher scores mean worse outcome	24 hours, 3 months and 6 months after childbirth
Secondary	Maternal Pain	Numerical Pain score (0-10) higher scores mean worse outcome	24 hours, 3 months and 6 months after childbirth
Secondary	Breastfeeding	Exclusive breastfeeding	24 hours, 3 months and 6 months after childbirth