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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02870712

Acronym

ImSOLENCE

Enrollment

112

Registered

2016-08-17

Start date

2017-03-21

Completion date

2018-09-04

Last updated

2021-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delivery, Obstetric, Parturition

Keywords

perineal tear of first degree, suture

Brief 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.

Interventions

PROCEDURESuture of perineum

suture of the tear to obtain hemostasis

PROCEDUREhemostatis by digital compression

Digital compression of the tear to obtain hemostasis

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

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

Design outcomes

Primary

Measure	Time frame
Composite Outcome Measure for success defined by : - a negligible pain, - satisfactory healing, - no bleeding and infection of the perineum	ten day after childbirth

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026