- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07758959
Comparison of Purse String Suture vs Transverse Mattress Suture to Maintain Hemostasis in Thinned-out Caesarean Sections Scars
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)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54070
- Lahore General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1 Arm Title: Purse-String Suture
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.
|
Purse-string suturing of the thinned-out lower uterine segment during repeat cesarean section.
|
|
Experimental: Arm 2 Arm Title: Transverse Mattress Suture
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.
|
Transverse mattress suturing of the thinned-out lower uterine segment during repeat cesarean section.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Achieve Hemostasis
Time Frame: During the surgical procedure (intraoperative)
|
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 Frame: Intraoperative (during cesarean section)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Sutures Required to Achieve Hemostasis
Time Frame: Intraoperative (during cesarean section)
|
Number of hemostatic sutures required to achieve complete hemostasis of the thinned-out lower uterine segment during repeat cesarean section.
|
Intraoperative (during cesarean section)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- lahore general hospital
- irb no 199/24 (Other Identifier: lahore general hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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