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NCT02870712: 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
NA trial testing Suture of perineum in Parturition in 112 participants. Completed in 4 September 2018.
13 July 2018
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire de Besancon |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 112 |
| Start date | 21 March 2017 |
| Primary completion | 13 July 2018 |
| Estimated completion | 4 September 2018 |
| Sites | 1 location across France |
Drugs / interventions tested
- Suture of perineum
- hemostatis by digital compression
Conditions studied
- Parturition — all drugs for Parturition →
- Delivery, Obstetric — all drugs for Delivery, Obstetric →
Sponsor
Centre Hospitalier Universitaire de Besancon
Who can join
18 and older, female only, with Parturition or Delivery, Obstetric. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02870712
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02870712 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire de Besancon
- Last refreshed: 3 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02870712.
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