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

Study Overview
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Brief Summary
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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.

Official Title
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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, ImSOLENCE Study

Conditions
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Parturition, Delivery, Obstetric

Intervention / Treatment
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* Procedure: Suture of perineum
* Procedure: hemostatis by digital compression


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: suture directed<br>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. | Procedure: Suture of perineum<br>* suture of the tear to obtain hemostasis<br>Procedure: hemostatis by digital compression<br>* Digital compression of the tear to obtain hemostasis<br>|
| Active Comparator: systematic suture<br>systematic suture tears following current recommendations | Procedure: Suture of perineum<br>* suture of the tear to obtain hemostasis<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perineal tear of first degree, suture