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

Scar; Previous Cesarean Section Clinical Trial

— OPSTAR  

Official title:

Optimierung Der Uterotomie-Wundheilung Nach Re-Sectio Caesarea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703519
• Other study ID #: OPSTAR
• Status: Completed
• Phase: N/A
• First received: March 6, 2016
• Last updated: September 8, 2016
• Start date: November 2014
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

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

Intervention

Procedure:
• resection of uterine scar tissue
resection of uterine scar tissue of a previous cesarean section during a second cesarean section

Locations

Country	Name	City	State
Germany	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

Sponsors (2)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg	Otto-von-Guericke University Magdeburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of uterine Cesarean section scars using transvaginal ultrasound		6-9 months	No
Secondary	median myometrial thickness of lower uterine segment using transvaginal ultrasound		6-9months	No