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CompletedNCT02870712ImSOLENCEUpdated Aug 3, 2021

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

An interventional study of Suture of perineum and hemostatis by digital compression in Parturition and Delivery, Obstetric, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-03.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Parturition
  • Delivery, Obstetric

Keywords

  • perineal tear of first degree
  • suture
03

In context

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Known haemostatic anomaly
  • Premature birth (before 37)
  • caesarean
  • Instrumental delivery
  • Placenta and / or uterine revision
  • episiotomy
  • perineal tear ≥ 2nd degree
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
112 participants (actual)

Study arms

  • 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 · Procedure: hemostatis by digital compression

  • Active comparator
    systematic suture

    systematic suture tears following current recommendations

    Procedure: Suture of perineum

Interventions

  • ProcedureSuture of perineum

    suture of the tear to obtain hemostasis

  • Procedurehemostatis by digital compression

    Digital compression of the tear to obtain hemostasis

06

What researchers measure

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

07

Study locations

1 site
  • CHU de Besançon
    Besançon, 25000, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02870712
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Aug 17, 2016
Start date
Mar 21, 2017
Primary completion
Jul 13, 2018
Completion
Sep 4, 2018
Last update
Aug 3, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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