ImSOLENCE: 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

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Completed

CT.gov ID

NCT02870712

Collaborator

(none)

112

Enrollment

Location

Arms

17.5

Actual Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parturition Delivery, Obstetric	Procedure: Suture of perineum Procedure: hemostatis by digital compression	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 21, 2017

Actual Primary Completion Date :

Jul 13, 2018

Actual Study Completion Date :

Sep 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: suture directed 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 suture of the tear to obtain hemostasis Procedure: hemostatis by digital compression Digital compression of the tear to obtain hemostasis
Active Comparator: systematic suture systematic suture tears following current recommendations	Procedure: Suture of perineum suture of the tear to obtain hemostasis

Arm

Intervention/Treatment

Experimental: suture directed

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

suture of the tear to obtain hemostasis

Procedure: hemostatis by digital compression

Digital compression of the tear to obtain hemostasis

Active Comparator: systematic suture

systematic suture tears following current recommendations

Procedure: Suture of perineum

suture of the tear to obtain hemostasis

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Besançon	Besançon		France	25000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT02870712

Other Study ID Numbers:

P/2016/296

First Posted:

Aug 17, 2016

Last Update Posted:

Aug 3, 2021

Last Verified:

Sep 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Besancon

perineal tear of first degree

suture

Study Results

No Results Posted as of Aug 3, 2021