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Completed

NCT Number: NCT02870712

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Besançon

Besançon, 25000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suture of perineum

Procedure

suture of the tear to obtain hemostasis

hemostatis by digital compression

Procedure

Digital compression of the tear to obtain hemostasis

Primary outcomes

  1. Composite Outcome Measure for success defined by : - a negligible pain, - satisfactory healing, - no bleeding and infection of the perineum

    Time frame: ten day after childbirth

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study 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

Acronym: ImSOLENCE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2016
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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