Optimization of the Healing Process of the Uterine Scar Tissue After Re-cesarean Section (OPSTAR)
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|ClinicalTrials.gov Identifier: NCT02703519|
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : September 9, 2016
This prospective, controlled, clinical, intervention study measures the number of uterine Cesarean section scars and median myometrial thickness of women who underwent two Cesarean sections six to nine months after their last Cesarean section using transvaginal ultrasound.
It is the purpose of the study to assess if a resection of the uterine scar from a previous Cesarean section during a second Cesarean section could lead to a decrease in risk for subsequent pregnancies.
|Condition or disease||Intervention/treatment||Phase|
|Scar; Previous Cesarean Section Complications; Cesarean Section, Wound, Dehiscence||Procedure: resection of uterine scar tissue||Not Applicable|
The average number of Cesarean sections in Germany has doubled from 1991 to 2011, making up 32,1% of all deliveries in 2011.
Several studies describe instances in which pregnancies following a previous Cesarean section were accompanied by complications such as life-threatening bleeding, placenta previa, placenta accreta, increta or percreta and dehiscence or uterine rupture.
The risk of those complications increases further with the uterine scar tissue of a second Cesarean section.
Today it is already common practice to resect uterine scars if the scar of a previous Cesarean section becomes symptomatic, or when a non-symptomatic uterine rupture or serious dehiscence are discovered during a Cesarean delivery.
In this study all participants of the interventional group are examined via intraoperative ultrasound to identify the first uterine Cesarean section scar and resect it completely.
Six to nine months after the resection participants will return for a one time follow-up. At this time, the investigators will measure the number of uterine scars and median myometrial thickness using transvaginal ultrasound. The results will be compared with those of two control groups, consisting of women who underwent either one or two Cesarean sections without the intervention.
The aim of the present study is to asses if the number of uterine scars and median myometrial thickness can be improved by the resection of the first uterine scar during a subsequent Cesarean section.
This will allow the investigators to draw conclusions regarding the benefit of routine resections of uterine Cesarean section scars, and whether this practice could lead to a decreased risk for women undergoing two or more Cesarean sections.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Optimierung Der Uterotomie-Wundheilung Nach Re-Sectio Caesarea|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
No Intervention: 1 cesarean section
No Intervention: 2 cesarean sections
Experimental: resection of uterine scar tissue
2 cesarean sections with resection of uterine scar tissue from first cesarean section
Procedure: resection of uterine scar tissue
resection of uterine scar tissue of a previous cesarean section during a second cesarean section
- number of uterine Cesarean section scars using transvaginal ultrasound [ Time Frame: 6-9 months ]
- median myometrial thickness of lower uterine segment using transvaginal ultrasound [ Time Frame: 6-9months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703519
|Maternity Clinic/Perinatal Treatment Center, Halle University Hospital, Martin-Luther-Universität Halle-Wittenberg|
|Halle (Saale), Saxony-Anhalt, Germany|
|Maternity Clinic, Magdeburg University Hospital|
|Magdeburg, Saxony-Anhalt, Germany|
|Principal Investigator:||Gregor Seliger, Dr. med.||Maternity Clinic/Perinatal Treatment Center, Halle University Hospital, Martin-Luther-Universität Halle-Wittenberg|
|Study Chair:||Michael Tchirikov, Prof.||Maternity Clinic/Perinatal Treatment Center, Halle University Hospital, Martin-Luther-Universität Halle-Wittenberg|
|Principal Investigator:||Serben-Dan Costa, Prof.||Maternity Clinic, Magdeburg University Hospital|