Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT02703519
Study type Interventional
Source Martin-Luther-Universität Halle-Wittenberg
Contact
Status Completed
Phase N/A
Start date November 2014
Completion date August 2016

See also
  Status Clinical Trial Phase
Recruiting NCT05555602 - Observation of the Comfort and Efficacy of CO2 Laser Combined With Cryo 6 for Burn or Linear Scars. N/A
Recruiting NCT05745935 - Role of Local Skin Incision Infiltration by Oxytocin On Wound Healing N/A
Completed NCT02827604 - Preoperative and Intraoperative Sonographic Assessment of Lower Uterine Segment Thickness at Term in Women With Previous Cesarean Delivery - a Ultrasound Method Comparison Study N/A
Completed NCT02827591 - Assessing the Stability of Uterine Scar Tissue in Women With Previous History of Caesarean Section Using Multimodal Analyses of the Lower Uterine Segment Including Quantitative Sonography N/A
Recruiting NCT04205292 - Cesarean Scar Pregnancy Managed by Dilatation and Evacuation (D&E) Versus Hysteroscopic Surgery N/A
Completed NCT02775747 - PRP Gel in Wound Closure in Recurrent CS Phase 1/Phase 2
Completed NCT04053413 - University of North Carolina-Healthwise Partnership Project on Birth Options Decision Aid N/A