Randomized Controlled Trial of the Effectiveness of Perineal Pain and Security of the Suture Led by the Result of Hemostasis Versus Manual Compression Routine Suture Perineal Tears of First Degree During Childbirth

Not Applicable

Completed

• Conditions: Delivery, Obstetric; Parturition
• Interventions: Procedure: Suture of perineum; Procedure: hemostatis by digital compression

• Registration Number: NCT02870712
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

During childbirth, the recommendations have evolved to a restriction of episiotomy. This reduction results in an increase of superficial vaginal and perineal tears. These lesions are usually routinely sutured which often causes the onset of discomfort and pain in the immediate postpartum period. Gordon showed, in 1998, improved comfort and pain when the skin was not sutured perineal tears during the second degree. Others have compared different techniques in the same indications (separated points running suture, biological adhesive) without demonstrated impact. These studies were not interested in isolated perineal tears or first degree or the application of a simple manual compression with or without a suture according to the result of hemostasis.

Our objective is to evaluate the possibility of not suture the perineum of the first degree. The use of suture only result of bleeding not yielding to manual compression.

Our approach is guided by the principles of "primum non nocere" and discerning about the dogmatic systematization.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-17
• Study Start: 2017-03-21
• Primary Completion: 2018-07-13
• Status Verified: 2018-09
• Study Completion: 2018-09-04
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 112

Inclusion Criteria

• single Pregnancy
• primiparae
• delivery by spontaneous vaginal delivery
• forward Delivery (≥ 37 weeks)
• cephalic presentation
• children living
• perineal tear or isolated first-degree vaginal tear

Exclusion Criteria

• Known haemostatic anomaly
• Premature birth (before 37)
• caesarean
• Instrumental delivery
• Placenta and / or uterine revision
• episiotomy
• perineal tear ≥ 2nd degree

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
suture directed	Suture of perineum	The suture of the perineum is headed by obtaining hemostasis by digital compression 5 minutes; If hemostasis is obtained, the perineum will not be sutured. In case of failure of hemostasis, suture of the perineum will be realized.
suture directed	hemostatis by digital compression	The suture of the perineum is headed by obtaining hemostasis by digital compression 5 minutes; If hemostasis is obtained, the perineum will not be sutured. In case of failure of hemostasis, suture of the perineum will be realized.
systematic suture	Suture of perineum	systematic suture tears following current recommendations

Primary Outcome Measures

Name	Time	Method
Composite Outcome Measure for success defined by : - a negligible pain, - satisfactory healing, - no bleeding and infection of the perineum	ten day after childbirth

Trial Locations

Locations (1)

CHU de Besançon; 🇫🇷 Besançon, France