Clinical trial NCT04799457: Comparison the Effect of Uterine Closure Technique Difference on Uterine Niche After Caesarean Delivery.
Official title: Comparison the Effect of Uterine Closure Technique Difference on Uterine Niche After Caesarean Delivery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Niche
Closure; Incomplete, Uterus
Keywords: niche
caesarean section
technique
uterine closure
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double Blinded Randomised Controlled Trial
Primary purpose: PREVENTION

Brief summary: Caesarean section scar may have result as isthmocele or scar detachment during pregnancy which is in few years after previous delivery. Uterine niche is the most effectively used measurement side of uterus to estimate for these detachment complications. The aim of this study is to support this niche site by supporting the classical uterine closure technique.

Detailed description: Cesarean delivery rate continues to increase in world in concern with uterine scar complications as placental invasion abnormalities, isthmocele or previous scar detachment during pregnancy (post surgical long term complications). Uterine niche is the presence of a hypoechoic area within the myometrium on the lower uterine segment, showing a defect of the myometrium at the site of a previous cesarean delivery. Some surgical techniques have been trying to support this area to prevent the post surgical long term complications. In this study the investigators have been trying to find out a new technique by applying supporting sutures during uterine closure in cesarean section. Three months after the surgery, the uterine niche measurement will be examined with ultrasonography for both study and classical groups and results will be compared between the groups.

Eligibility criteria: Inclusion Criteria:

* Primigravid elective caesarian delivery candidates
* The participants will have not any uterine contraction or cervical dilatation before delivery.
* Having no systemic or obstetric illnesses
* Participants who are accept to participate in this study with their written consent.

Exclusion Criteria:

* Previous caesarian delivery
* Having uterine contraction or cervical dilatation
* Smoking cigarettes
* Having systemic or obstetric illnesses

Primary outcomes:
measure: Number of participants for each group for study
timeFrame: Up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof Dr Suleyman Yalcin Goztepe City Hospital
state: Kadikoy
Study officials:
affiliation: Prof Dr Suleyman Yalcin Goztepe City Hospital
name: Ergul Demircivi Bor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bennich G, Rudnicki M, Wilken-Jensen C, Lousen T, Lassen PD, Wojdemann K. Impact of adding a second layer to a single unlocked closure of a Cesarean uterine incision: randomized controlled trial. Ultrasound Obstet Gynecol. 2016 Apr;47(4):417-22. doi: 10.1002/uog.15792.
citation: Roberge S, Demers S, Girard M, Vikhareva O, Markey S, Chaillet N, Moore L, Paris G, Bujold E. Impact of uterine closure on residual myometrial thickness after cesarean: a randomized controlled trial. Am J Obstet Gynecol. 2016 Apr;214(4):507.e1-507.e6. doi: 10.1016/j.ajog.2015.10.916. Epub 2015 Nov 11.
citation: Sevket O, Ates S, Molla T, Ozkal F, Uysal O, Dansuk R. Hydrosonographic assessment of the effects of 2 different suturing techniques on healing of the uterine scar after cesarean delivery. Int J Gynaecol Obstet. 2014 Jun;125(3):219-22. doi: 10.1016/j.ijgo.2013.11.013. Epub 2014 Feb 28.
citation: Stegwee SI, Jordans I, van der Voet LF, van de Ven PM, Ket J, Lambalk CB, de Groot C, Hehenkamp W, Huirne J. Uterine caesarean closure techniques affect ultrasound findings and maternal outcomes: a systematic review and meta-analysis. BJOG. 2018 Aug;125(9):1097-1108. doi: 10.1111/1471-0528.15048. Epub 2018 Jan 30.