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Completed

NCT Number: NCT05854888

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

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.

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Key information

Conditions

Perineal Tear Resulting From Childbirth

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sílvia Rodrigues

Braga, 4715-304, Portugal

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perineal Massage and Warm Compresses (PeMWaC)

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)

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.

Primary outcomes

  1. Intact Perineum

    Time frame: up to 10 minutes after childbirth

    Absence of tissue separation at any site, without vaginal tears or any other degree of perineal trauma)

  2. First-degree perineal tear

    Time frame: up to 10 minutes after childbirth

    Skin and vaginal tear

  3. Second-degree perineal tear

    Time frame: up to 10 minutes after childbirth

    Skin and muscle tear (posterior compartment)

  4. OASIS

    Time frame: 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

  5. OASIS + episiotomy

    Time frame: up to 10 minutes after childbirth

    Third and fourth degree tear with episiotomy

  6. Episiotomy

    Time frame: up to 10 minutes after childbirth

    without spontaneous perineal trauma or vaginal tears

  7. Episiotomy and first degree tear

    Time frame: up to 10 minutes after childbirth

    Episiotomy with spontaneous skin tear

  8. Episiotomy and second degree tear

    Time frame: up to 10 minutes after childbirth

    Episiotomy and spontaneous skin and muscle tear

  9. OASIS with/without episiotomy

    Time frame: up to 10 minutes after childbirth

    with and without episiotomy

  10. Vaginal tears

    Time frame: up to 10 minutes after childbirth

    only vaginal tear

  11. Anterior Compartment tears

    Time frame: up to 10 minutes after childbirth

    Without episiotomy or any other degree of perineal trauma

Secondary outcomes

  1. Admission to Neonatal Intensive Unit Care

    Time frame: up to 2 hours after childbirth

    Admission to Neonatal Intensive Unit Care

  2. Apgar 5 minutes

    Time frame: 5 minutes after childbirth

    Apgar Score at 5 minutes (0-10) higher scores mean better outcome

  3. Maternal satisfaction with intervention

    Time frame: 24 hours after childbirth

    Question about maternal satisfaction with intervention

  4. Recommend an intervention allocated to a friend

    Time frame: 24 hours after childbirth

    Question about whether women would recommend the intervention they received to a friend

  5. Female Sexual Function Index score

    Time frame: 24 hours, 3 months and 6 months after childbirth

    Female Sexual Function Index score (2-36) higher scores mean better outcome

  6. Pelvic Floor Dysfunction symptoms

    Time frame: 24 hours, 3 months and 6 months after childbirth

    Pelvic Floor Distress Inventory (0-300) higher scores mean worse outcome

  7. Maternal Pain

    Time frame: 24 hours, 3 months and 6 months after childbirth

    Numerical Pain score (0-10) higher scores mean worse outcome

  8. Breastfeeding

    Time frame: 24 hours, 3 months and 6 months after childbirth

    Exclusive breastfeeding

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Registry information

Official study title

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

Acronym: PeMWaC

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
May 11, 2023
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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