Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06980220
Status:
COMPLETED
Last Update Posted:
2025-05-20
First Post:
2025-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Perineal Massage With Lubricating Gel During Expulsion on Perineal Outcomes
Sponsor:
Centre Hospitalier de Gonesse
Organization:
Study Overview
Official Title:
Impact of Perineal Massage With Lubricating Gel During Expulsion on Perineal Outcomes
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: