Trials / Completed
CompletedNCT02870712
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
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 112 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Besancon · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Suture of perineum | suture of the tear to obtain hemostasis |
| PROCEDURE | hemostatis by digital compression | Digital compression of the tear to obtain hemostasis |
Timeline
- Start date
- 2017-03-21
- Primary completion
- 2018-07-13
- Completion
- 2018-09-04
- First posted
- 2016-08-17
- Last updated
- 2021-08-03
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02870712. Inclusion in this directory is not an endorsement.