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Completed

NCT Number: NCT02703519

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

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.

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Key information

Conditions

Scar; Previous Cesarean Section Cicatrix Complications; Cesarean Section, Wound, Dehiscence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Genital Diseases Genital Diseases, Female Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Placenta Accreta Placenta Diseases Pregnancy Complications Rupture Urogenital Diseases Uterine Diseases Uterine Rupture Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maternity Clinic/Perinatal Treatment Center, Halle University Hospital, Martin-Luther-Universität Halle-Wittenberg, Halle, Saxony-Anhalt, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

resection of uterine scar tissue

Procedure

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

Primary outcomes

  1. number of uterine Cesarean section scars using transvaginal ultrasound

    Time frame: 6-9 months

Secondary outcomes

  1. median myometrial thickness of lower uterine segment using transvaginal ultrasound

    Time frame: 6-9months

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Collaborators

  • Otto-von-Guericke University Magdeburg

Registry information

Official study title

Optimierung Der Uterotomie-Wundheilung Nach Re-Sectio Caesarea

Acronym: OPSTAR

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 9, 2016
Registry last updated
Sep 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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