Trial Outcomes & Findings for Long Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure (NCT NCT01289262)

Results Overview

It will be noted whether placenta previa in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

168 participants

Primary outcome timeframe

Subsequent pregnancy within next average 6 years

Results posted on

2024-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	Purse String Closure Technique Uterine Kerr incision will be closed with purse string suture. Purse string closure technique: Uterine incision will be closed with purse string closure technique.	Continuously Locked Closure Technique Uterine Kerr incision will be closed with continuously locked closure technique. Continuously locked closure technique: Uterine incision will be closed with continuously locked closure technique
Overall Study STARTED	84	84
Overall Study COMPLETED	51	65
Overall Study NOT COMPLETED	33	19

Reasons for withdrawal

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

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuously Locked Closure Technique n=65 Participants Uterine Kerr incision will be closed with continuously locked closure technique. Continuously locked closure technique: Uterine incision will be closed with continuously locked closure technique	Total n=116 Participants Total of all reporting groups	Purse String Closure Technique n=51 Participants Uterine Kerr incision will be closed with purse string suture. Purse string closure technique: Uterine incision will be closed with purse string closure technique.
Age, Continuous	28.5 Years STANDARD_DEVIATION 5.3 • n=7 Participants	29.05 Years STANDARD_DEVIATION 5.15 • n=5 Participants	29.6 Years STANDARD_DEVIATION 5.0 • n=5 Participants
Sex: Female, Male Female	65 Participants n=7 Participants	116 Participants n=5 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Region of Enrollment Turkey	65 participants n=7 Participants	116 participants n=5 Participants	51 participants n=5 Participants

PRIMARY outcome

Timeframe: Subsequent pregnancy within next average 6 years

Population: Eighteen of 51 patients in the study group (purse string) became pregnant. Of the 18 patients in the study group, pregnancy was terminated by cesarean section without low lying placenta, placenta previa marginalis and placenta previa totalis. Of the 65 patients in the control group, 23 became pregnant. Three of them developed low lying placenta, two developed placenta previa marginalis, and one developed placenta previa totalis.

It will be noted whether placenta previa in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.

Outcome measures

Outcome measures
Measure	Purse String Closure Technique n=18 Participants Uterine Kerr incision will be closed with purse string suture. Purse string closure technique: Uterine incision will be closed with purse string closure technique.	Continuously Locked Closure Technique n=23 Participants Uterine Kerr incision will be closed with continuously locked closure technique. Continuously locked closure technique: Uterine incision will be closed with continuously locked closure technique
Placenta Previa Subsequent pregnancy without low lying placenta, placenta previa marginalis and totalis	18 Participants	17 Participants
Placenta Previa Low lying placenta	0 Participants	3 Participants
Placenta Previa Placenta previa marginalis	0 Participants	2 Participants
Placenta Previa Placenta previa totalis	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Subsequent pregnancy within next average 6 years

Population: Placental adhesion (insertion) anomaly did not develop in any of the 18 cases who became pregnant in the Turan technique (purse string) group and in none of the 23 cases who became pregnant in the control (continuously locked closure) group.

It will be noted whether placenta insertion anomalies (placenta accreta and others) in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.

Outcome measures

Outcome measures
Measure	Purse String Closure Technique n=18 Participants Uterine Kerr incision will be closed with purse string suture. Purse string closure technique: Uterine incision will be closed with purse string closure technique.	Continuously Locked Closure Technique n=23 Participants Uterine Kerr incision will be closed with continuously locked closure technique. Continuously locked closure technique: Uterine incision will be closed with continuously locked closure technique
Placenta Insertion Anomalies No placental adhesion (insertion) anomaly	18 Participants	23 Participants
Placenta Insertion Anomalies Placental adhesion (insertion) anomaly	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Subsequent pregnancy within next average 6 years

Population: Uterine rupture (incomplete or complete, dehiscence of uterine incision) did not develop in any of the 18 cases who became pregnant in the Turan technique (Purse string closure technique) group and in none of the 23 cases who became pregnant in the control (continuously locked closure technique) group.

It will be noted whether uterine rupture (incomplete or complete, dehiscence of uterine incision) in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.

Outcome measures

Outcome measures
Measure	Purse String Closure Technique n=18 Participants Uterine Kerr incision will be closed with purse string suture. Purse string closure technique: Uterine incision will be closed with purse string closure technique.	Continuously Locked Closure Technique n=23 Participants Uterine Kerr incision will be closed with continuously locked closure technique. Continuously locked closure technique: Uterine incision will be closed with continuously locked closure technique
Uterine Rupture Without uterine rupture (incomplete or complete, dehiscence of uterine incision)	18 Participants	23 Participants
Uterine Rupture With uterine rupture (incomplete or complete, dehiscence of uterine incision)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to average 6 years

Population: Intra-abdominal filmy adhesion was detected in 2 of 18 pregnant cases in the Turan technique (purse string) group and intra-abdominal adhesion developed in 6 of 23 cases who became pregnant in the control (Continuously locked closure technique) group. Three of them were filmy and the other three were dense adhesions involving the omentum and intestine.

It will be noted whether intra-abdominal adhesion in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.

Outcome measures

Outcome measures
Measure	Purse String Closure Technique n=18 Participants Uterine Kerr incision will be closed with purse string suture. Purse string closure technique: Uterine incision will be closed with purse string closure technique.	Continuously Locked Closure Technique n=23 Participants Uterine Kerr incision will be closed with continuously locked closure technique. Continuously locked closure technique: Uterine incision will be closed with continuously locked closure technique
Intra-abdominal Adhesions Dense intra-abdominal adhesions	0 Participants	3 Participants
Intra-abdominal Adhesions No intra-abdominal adhesions	16 Participants	17 Participants
Intra-abdominal Adhesions Filmy intra-abdominal adhesions	2 Participants	3 Participants

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

DrLutfiKirdarTRH

Phone: 00905323513423

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place