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

NCT ID: NCT05854888

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-07-01

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).

Conditions

Perineal Tear Resulting From Childbirth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

PeMWaC (Perineal Massage and Warm Compresses)

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.

Group Type: EXPERIMENTAL

Perineal Massage and Warm Compresses (PeMWaC)

Intervention Type: PROCEDURE

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, 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.

Group Type: ACTIVE_COMPARATOR

Control Group (Hands-on)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade do Porto

OTHER

Sponsor Role: lead

Responsible Party

Sílvia Leite Rodrigues

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sílvia Rodrigues, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute Biomedical Sciences Abel Salazar-University of Porto

Locations

Sílvia Rodrigues

Braga, , Portugal

Countries

Portugal

References

Rodrigues S, Silva P, Borges AC, de Sousa NQ, Silva JN, Escuriet R. Effect of Perineal Massage and Warm Compresses Technique in Postpartum Pelvic Floor Dysfunction. A Secondary Analysis from a Randomised Controlled Trial. Reprod Sci. 2024 Apr;31(4):1006-1016. doi: 10.1007/s43032-023-01424-4. Epub 2023 Dec 14.

Reference Type: DERIVED

PMID: 38097899 (View on PubMed)

Other Identifiers

201802476

Identifier Type: -

Identifier Source: org_study_id