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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)

C

Centre Hospitalier Universitaire de Besancon

Status

Completed

Conditions

Parturition
Delivery, Obstetric

Treatments

Procedure: Suture of perineum
Procedure: hemostatis by digital compression

Study type

Interventional

Funder types

Other

Identifiers

NCT02870712
P/2016/296

Details and patient eligibility

About

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.

Enrollment

112 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

112 participants in 2 patient groups

suture directed
Experimental group
Description:
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.
Treatment:
Procedure: Suture of perineum
Procedure: hemostatis by digital compression
systematic suture
Active Comparator group
Description:
systematic suture tears following current recommendations
Treatment:
Procedure: Suture of perineum

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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