CClinicalTrials.gg
CompletedNCT06980220Updated May 20, 2025

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

An observational study in Perineal Massage, Perineum/Injuries and Labor, Obstetric, sponsored by Centre Hospitalier de Gonesse. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-20.

Sponsored by Centre Hospitalier de Gonesse · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
52
Ages
18 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Perineal Massage
  • Perineum/Injuries
  • Labor, Obstetric
  • Episiotomy
03

In context

Lead sponsor

Centre Hospitalier de Gonesse is the lead sponsor of 15 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Instrumental births
  • In-seat births
  • Premature births
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
52 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

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

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

07

Study locations

1 site
  • France
    Gonesse, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06980220
Lead sponsor
Centre Hospitalier de Gonesse
Responsible party
Sponsor
First posted
May 20, 2025
Start date
Oct 15, 2023
Primary completion
May 15, 2024
Completion
May 15, 2024
Last update
May 20, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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