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Optimization of the Healing Process of the Uterine Scar Tissue After Re-cesarean Section

Optimierung Der Uterotomie-Wundheilung Nach Re-Sectio Caesarea

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02703519
Acronym
OPSTAR
Enrollment
116
Registered
2016-03-09
Start date
2014-11-30
Completion date
2016-08-31
Last updated
2016-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications; Cesarean Section, Wound, Dehiscence, Scar; Previous Cesarean Section

Keywords

cesarean section, repeat, uterine scar tissue, transvaginal ultrasound, uterine rupture, placenta accreta, placenta percreta, placenta increta

Brief 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.

Detailed 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.

Interventions

PROCEDUREresection of uterine scar tissue

resection of uterine scar tissue of a previous cesarean section during a second cesarean section

Sponsors

Otto-von-Guericke University Magdeburg
CollaboratorOTHER
Martin-Luther-Universität Halle-Wittenberg
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years or older * primary or secondary indication for cesarean section 6 to 9 months prior to the examination date

Exclusion criteria

* \<18 years old * current pregnancy * congenital deformity of the uterus * former surgery of the uterine myometrium

Design outcomes

Primary

MeasureTime frame
number of uterine Cesarean section scars using transvaginal ultrasound6-9 months

Secondary

MeasureTime frame
median myometrial thickness of lower uterine segment using transvaginal ultrasound6-9months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026