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

Universidade do Porto

Status: Completed

Conditions: Perineal Tear Resulting From Childbirth

Treatments: Procedure: Perineal Massage and Warm Compresses (PeMWaC); Procedure: Control Group (Hands-on)

Study type: Interventional

Funder types: Other

Identifiers

NCT05854888

201802476

Details and patient eligibility

About

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.

Full 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).

Enrollment: 800 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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800 participants in 2 patient groups

PeMWaC (Perineal Massage and Warm Compresses)

Experimental group

Description:

In the second stage of labor, the midwife performed a soft perineal massage between 3 o'clock and 9 o'clock positions (U-shaped reciprocating motion) wearing sterile gloves and lubricated their hand with sterile lubricant. The massage lasted 10 minutes and the degree of downward pressure by the thumb was determined according to mothers' response. Perineal massage was established on the II Hodge Plan, between maternal contractions and regardless of maternal position. The women could adopted the birthing position they prefer. The application of warm compresses was performed by the midwife between the III and IV Hodge plans, during pushing and regardless of the mother's position. A metal jug filled with warm water (between 45° and 59°C) was used to soak the compresses, which were squeezed out before being gently placed on the perineum during contractions.

Treatment:

Procedure: Perineal Massage and Warm Compresses (PeMWaC)

Control group (Hands-on)

Active Comparator group

Description:

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, while the non-dominant hand supported the infant's head, allowing external rotation and spontaneous birth of the shoulders. After both shoulders were removed, the midwife removed the dominant hand from the posterior perineum.

Treatment:

Procedure: Control Group (Hands-on)