Comparison of Purse String Suture vs Transverse Mattress Suture to Maintain Hemostasis in Thinned-out Caesarean Sections Scars
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Time to Achieve Hemostasis
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Females aged 18 to 40 years.
- •Gestational age >37 weeks at the time of delivery.
- •Parity <
- •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).
Arms & Interventions
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.
Intervention: Purse-String Suture (Procedure)
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.
Intervention: Transverse Mattress Suture (Procedure)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Number of Sutures Required to Achieve Hemostasis(Intraoperative (during cesarean section))
Investigators
Natasha Bushra
Assistant Professor obstetrics and gynaecology
Lahore General Hospital
