Trial Outcomes & Findings for Short Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure (NCT NCT01287611)

Results Overview

A wedge-shaped distortion in the integrity of the uterine incision scar during transvaginal ultrasonographic examination at 6 weeks after C/S was accepted as cesarean scar defect in the uterine incisional line and recorded as primary outcome measure, and two groups will be compared.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

168 participants

Primary outcome timeframe

6 weeks after C/S

Results posted on

2023-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Purse String Closure Technique Purse string closure: Uterine Kerr incision will be closed with purse string suture	Continuously Locked Closure Technique Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
Overall Study STARTED	84	84
Overall Study The Number of Patients Who Underwent C/S	84	84
Overall Study COMPLETED	51	65
Overall Study NOT COMPLETED	33	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Purse String Closure Technique Purse string closure: Uterine Kerr incision will be closed with purse string suture	Continuously Locked Closure Technique Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
Overall Study Lost to Follow-up	29	16
Overall Study Exclusion due to expanded Kerr incision	4	3

Baseline Characteristics

Short Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Purse String Closure Technique n=51 Participants Purse string closure: Uterine Kerr incision will be closed with purse string suture	Continuously Locked Closure Technique n=65 Participants Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing	Total n=116 Participants Total of all reporting groups
Age, Continuous	29.6 years STANDARD_DEVIATION 5.0 • n=99 Participants	28.5 years STANDARD_DEVIATION 5.3 • n=107 Participants	29.05 years STANDARD_DEVIATION 5.15 • n=206 Participants
Sex: Female, Male Female	51 Participants n=99 Participants	65 Participants n=107 Participants	116 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment Turkey	51 participants n=99 Participants	65 participants n=107 Participants	116 participants n=206 Participants

PRIMARY outcome

Timeframe: 6 weeks after C/S

A wedge-shaped distortion in the integrity of the uterine incision scar during transvaginal ultrasonographic examination at 6 weeks after C/S was accepted as cesarean scar defect in the uterine incisional line and recorded as primary outcome measure, and two groups will be compared.

Outcome measures

Outcome measures
Measure	Purse String Closure Technique n=51 Participants Purse string closure: Uterine Kerr incision will be closed with purse string suture	Continuously Locked Closure Technique n=65 Participants Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
Cesarean Scar Defect in the Uterine Incisional Line	12 participants 4.38	39 participants 6.11

SECONDARY outcome

Timeframe: 6 weeks after C/S

Length of uterine incision after suturing will be examined and measured by ultrasonography, and two groups will be compared.

Outcome measures

Outcome measures
Measure	Purse String Closure Technique n=51 Participants Purse string closure: Uterine Kerr incision will be closed with purse string suture	Continuously Locked Closure Technique n=65 Participants Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
Length of Uterine Incision After Suturing	3.7 cm Standard Deviation 0.9	8.5 cm Standard Deviation 1.7

Adverse Events

Purse String Closure Technique

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Continuously Locked Closure Technique

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Cem Turan

DrLutfi

Phone: 00905323513423

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place