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)

Centre Hospitalier Universitaire de Besancon

Status: Completed

Conditions: Parturition; Delivery, Obstetric

Treatments: Procedure: Suture of perineum; Procedure: hemostatis by digital compression

Study type: Interventional

Funder types: Other

Identifiers

NCT02870712

P/2016/296

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

suture directed

Experimental group

Description:

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.

Treatment:

Procedure: Suture of perineum

Procedure: hemostatis by digital compression

systematic suture

Active Comparator group

Description:

systematic suture tears following current recommendations

Treatment:

Procedure: Suture of perineum