Clinical Trials Directory

Trials / Completed

CompletedNCT06980220

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

Status
Completed
Phase
Study type
Observational
Enrollment
52 (actual)
Sponsor
Centre Hospitalier de Gonesse · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers

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.

Conditions

Timeline

Start date
2023-10-15
Primary completion
2024-05-15
Completion
2024-05-15
First posted
2025-05-20
Last updated
2025-05-20

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06980220. Inclusion in this directory is not an endorsement.