Clinical trial NCT02703519: Optimization of the Healing Process of the Uterine Scar Tissue After Re-cesarean Section
Official title: Optimierung Der Uterotomie-Wundheilung Nach Re-Sectio Caesarea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar; Previous Cesarean Section
Complications; Cesarean Section, Wound, Dehiscence
Keywords: cesarean section, repeat
uterine scar tissue
transvaginal ultrasound
uterine rupture
placenta accreta
placenta percreta
placenta increta
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
Collaborators: name: Otto-von-Guericke University Magdeburg
First posted: 2016-03-09
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: number of uterine Cesarean section scars using transvaginal ultrasound
timeFrame: 6-9 months
Secondary outcomes:
measure: median myometrial thickness of lower uterine segment using transvaginal ultrasound
timeFrame: 6-9months
Other outcomes:
Locations:
city: Halle (Saale)
country: Germany
facility: Maternity Clinic/Perinatal Treatment Center, Halle University Hospital, Martin-Luther-Universität Halle-Wittenberg
state: Saxony-Anhalt
city: Magdeburg
country: Germany
facility: Maternity Clinic, Magdeburg University Hospital
state: Saxony-Anhalt
Study officials:
affiliation: Maternity Clinic/Perinatal Treatment Center, Halle University Hospital, Martin-Luther-Universität Halle-Wittenberg
name: Gregor Seliger, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maternity Clinic/Perinatal Treatment Center, Halle University Hospital, Martin-Luther-Universität Halle-Wittenberg
name: Michael Tchirikov, Prof.
role: STUDY_CHAIR
affiliation: Maternity Clinic, Magdeburg University Hospital
name: Serben-Dan Costa, Prof.
role: PRINCIPAL_INVESTIGATOR
References: