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

NCT02870712 | Completed

• 1 other identifier: P/2016/296
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Parturition; Delivery, Obstetric

Keywords

perineal tear of first degree; suture

Outcome Measures

Primary Outcomes (1)

• Composite Outcome Measure for success defined by : - a negligible pain, - satisfactory healing, - no bleeding and infection of the perineum

  ten day after childbirth

Study Arms (2)

suture directed

EXPERIMENTAL

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; Procedure: hemostatis by digital compression

systematic suture

ACTIVE COMPARATOR

systematic suture tears following current recommendations

Procedure: Suture of perineum

Interventions

Suture of perineum PROCEDURE

suture of the tear to obtain hemostasis

suture directed; systematic suture

hemostatis by digital compression PROCEDURE

Digital compression of the tear to obtain hemostasis

suture directed

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: August 17, 2016
• Study Start: March 21, 2017
• Primary Completion: July 13, 2018
• Study Completion: September 4, 2018
• Last Updated: August 3, 2021

Record last verified: 2018-09

Locations

FR (1)