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OpenTrials
Completed

NCT Number: NCT06980220

Impact of Perineal Massage With Lubricating Gel During Expulsion on Perineal Outcomes

The primary goal is to assess whether this practice reduces the incidence and severity of perineal tears. Secondary objectives include evaluating the impact of the massage on perineal pain in the postpartum period and on the episiotomy rate. Participants will include primiparous women with singleton pregnancies who delivered spontaneously via vaginal birth. Exclusion criteria include instrumental deliveries, breech presentations, and preterm births. Data will be collected through a questionnaire filled out by midwives immediately after birth, as well as additional data extracted from medical records. All data will be anonymized using a birth number code. The questionnaire collects information on whether a perineal massage was performed, the type of product used, the birth position, use of warm compresses, performance of the Ritgen maneuver, and perineal outcomes. The medical record will provide demographic and clinical data, including the mother's age, BMI, labor duration, pushing time, newborn weight, and head circumference. The study aims to provide evidence on whether perineal massage with gel at expulsion is an effective strategy to prevent severe perineal trauma and improve postpartum recovery.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

France

Gonesse, France

Who can participate

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

Inclusion criteria

  • Singleton pregnancy
  • Spontaneous vaginal delivery
  • Primiparous women (first-time mothers)

Exclusion criteria

  • Instrumental births
  • In-seat births
  • Premature births

Treatment and study plan

Primary outcomes

  1. Rate of Perineal Tears Following Perineal Massage with Lubricating Gel at Expulsion

    Time frame: 15/10/2023 - 15/05/2024

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Gonesse

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 20, 2025
Registry last updated
May 20, 2025

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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