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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02870712
Other study ID # P/2016/296
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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