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

Parturition Clinical Trial

— ImSOLENCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870712
• Other study ID #: P/2016/296
• Status: Completed
• Phase: N/A
• Start date: March 21, 2017
• Est. completion date: September 4, 2018

Study information

• Verified date: September 2018
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: September 4, 2018
• Est. primary completion date: July 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delivery, Obstetric
• Parturition

Intervention

Procedure:
• Suture of perineum
suture of the tear to obtain hemostasis
• hemostatis by digital compression
Digital compression of the tear to obtain hemostasis

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

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