Double-layer Versus Purse Uterine Closure Techniques : Impact on Residual Myometrial Thickness After Cesarean

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04871022

Enrollment

126

Registered

2021-05-04

Start date

2021-05-15

Completion date

2022-07-01

Last updated

2022-09-27

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

Conditions

Uterine Scar Defect

Keywords

niche

Brief summary

There are different surgical techniques of uterine closure during cesarean. Currently data suggest that the double layer unlocked closure technique is associated with better uterine scar healing, and this technique is considered the gold standard. This study compares two techniques of uterine closure on myometrium thickness: 1. Double layer unlocked suture; 2. Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium. The primary outcome is the mean residual myometrium thickness at the site of the uterine scar evaluated by transvaginal ultrasound at six months after cesarean.

Interventions

PROCEDUREDouble layer closure of the hysterotomy

Double layer closure with a first continuous unlocked suture of the deep portion of the myometrium and a second unlocked continuous suture that approximate the upper portion of the myometrium.

PROCEDUREPurse closure of the hysterotomy

Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 48 Years

Healthy volunteers

Yes

Inclusion criteria

* Planned cesarean * Primary cesarean * ≥ 38 gestational weeks

Exclusion criteria

* Previous cesarean * Women \< 18 years old * Multiple gestation * Mullerian anomalies * Active labor * Diabetes * BMI \>35 kg/m2 * Placenta praevia * Chronic systemic disease * Covid-19 infection

Design outcomes

Primary

Measure	Time frame
Residual myometrium thickness	6 months after intervention

Secondary

Measure	Time frame
Operative time	Same day of intervention: day 1
Estimated blood loss	Same day of intervention: day 1
Mean number of haemostatic sutures	Same day of intervention: day 1
scar width	Same day of intervention: day 1

Countries

Tunisia

Outcome results

None listed

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