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.

Study Overview

• Status: Completed
• Conditions: Episiotomy; Labor, Obstetric; Perineal Massage; Perineum/Injuries

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• France
  • Gonesse, France
    • France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study will select participants from primiparous women (first-time mothers) who have delivered through spontaneous vaginal births at the hospital. The population will consist of women with singleton pregnancies who are undergoing vaginal delivery without any complications requiring instrumental intervention or preterm delivery. The study will focus on a cohort of women who have received care from midwives, ensuring consistency in the delivery approach. Participants will be selected based on the inclusion criteria outlined and will be monitored for perineal outcomes, including the occurrence of perineal tears and postpartum pain.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Instrumental births
• In-seat births
• Premature births

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of Perineal Tears Following Perineal Massage with Lubricating Gel at Expulsion	15/10/2023 - 15/05/2024

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Gonesse

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Actual): May 15, 2024
• Study Completion (Actual): May 15, 2024

Study Registration Dates

• First Submitted: May 12, 2025
• First Submitted That Met QC Criteria: May 12, 2025
• First Posted (Estimated): May 20, 2025

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 0043_MATERNITE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No