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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
Sponsor:
Collaborator:
Otto-von-Guericke University Magdeburg
Information provided by (Responsible Party):
Gregor Seliger, Martin-Luther-Universität Halle-Wittenberg

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.


Condition or disease Intervention/treatment Phase
Scar; Previous Cesarean Section Complications; Cesarean Section, Wound, Dehiscence Procedure: resection of uterine scar tissue Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 1 cesarean section
control group
No Intervention: 2 cesarean sections
control group
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




Primary Outcome Measures :
  1. number of uterine Cesarean section scars using transvaginal ultrasound [ Time Frame: 6-9 months ]

Secondary Outcome Measures :
  1. median myometrial thickness of lower uterine segment using transvaginal ultrasound [ Time Frame: 6-9months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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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, Germany
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Otto-von-Guericke University Magdeburg
Investigators
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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

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Responsible Party: Gregor Seliger, Dr. med., chief resident, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT02703519     History of Changes
Other Study ID Numbers: OPSTAR
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gregor Seliger, Martin-Luther-Universität Halle-Wittenberg:
cesarean section, repeat
uterine scar tissue
transvaginal ultrasound
uterine rupture
placenta accreta
placenta percreta
placenta increta