NCT07758959

Brief Summary

Brief Summary The goal of this clinical trial is to compare the effectiveness of purse-string suture versus transverse mattress suture for achieving hemostasis in women with thinned-out lower uterine segment scars undergoing repeat cesarean section. The study aims to determine whether the purse-string suture technique provides faster and more effective hemostasis than the transverse mattress suture technique. The main questions it aims to answer are:

  • Does the purse-string suture reduce the time required to achieve hemostasis compared with the transverse mattress suture?
  • Does the purse-string suture reduce the number of additional sutures required to achieve adequate hemostasis? Researchers will compare purse-string suturing with transverse mattress suturing to determine which technique achieves hemostasis more efficiently in women with thinned-out cesarean section scars. Participants will:
  • Undergo repeat cesarean section under standard surgical care.
  • Be randomly assigned to receive either purse-string suturing or transverse mattress suturing for repair of the thinned-out lower uterine segment after closure of the first uterine layer.
  • Have the time required to achieve hemostasis and the number of sutures required recorded intraoperatively.
  • Receive routine postoperative management according to institutional protocols. Suggested improvement Although the thesis mentions only time to achieve hemostasis and number of sutures as outcomes, ClinicalTrials.gov prefers that the primary outcome be clearly identified. Since your sample size was calculated using time to achieve hemostasis, I recommend presenting it as:
  • Primary outcome: Time to achieve hemostasis (minutes)
  • Secondary outcomes: Number of sutures required for hemostasis; duration of cesarean section (minutes)

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Aug 2026Dec 2026

First Submitted

Initial submission to the registry

August 6, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

August 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 6, 2026

Last Update Submit

August 10, 2026

Conditions

Keywords

Cesarean SectionRepeat Cesarean Section

Outcome Measures

Primary Outcomes (2)

  • Time to Achieve Hemostasis

    Time (in minutes) required to achieve complete hemostasis of the thinned-out lower uterine segment following application of the assigned suturing technique during repeat cesarean section.

    During the surgical procedure (intraoperative)

  • Time to Achieve Hemostasis

    Time (in minutes) required to achieve complete hemostasis of the thinned-out lower uterine segment following application of the assigned suturing technique during repeat cesarean section.

    Intraoperative (during cesarean section)

Secondary Outcomes (1)

  • Number of Sutures Required to Achieve Hemostasis

    Intraoperative (during cesarean section)

Study Arms (2)

Arm 1 Arm Title: Purse-String Suture

EXPERIMENTAL

Participants undergoing repeat cesarean section with a thinned-out lower uterine segment scar underwent uterine repair using the purse-string suture technique to achieve hemostasis.

Procedure: Purse-String Suture

Arm 2 Arm Title: Transverse Mattress Suture

EXPERIMENTAL

Participants undergoing repeat cesarean section with a thinned-out lower uterine segment scar underwent uterine repair using the transverse mattress suture technique to achieve hemostasis.

Procedure: Transverse Mattress Suture

Interventions

Purse-string suturing of the thinned-out lower uterine segment during repeat cesarean section.

Arm 1 Arm Title: Purse-String Suture

Transverse mattress suturing of the thinned-out lower uterine segment during repeat cesarean section.

Arm 2 Arm Title: Transverse Mattress Suture

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Females aged 18 to 40 years.
  • Gestational age \>37 weeks at the time of delivery.
  • Parity \<5.
  • History of one or more previous cesarean sections.
  • Intraoperative evidence of a thinned-out lower uterine segment scar during repeat cesarean section.

You may not qualify if:

  • Preeclampsia (blood pressure ≥140/90 mmHg with proteinuria \>+1 on dipstick).
  • Gestational diabetes mellitus.
  • Placental abnormalities, including placenta previa, placenta accreta spectrum (accreta/increta), or placental abruption.
  • Previous uterine repair scar.
  • Coagulation disorder (prothrombin time \>15 seconds).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahore general hospital

Lahore, Punjab Province, 54070, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor obstetrics and gynaecology

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 11, 2026

Study Start

August 6, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to institutional and ethical restrictions and the absence of a predefined data-sharing plan.

Locations