Comparison the Effect of Uterine Closure Technique Difference on Uterine Niche After Caesarean Delivery.

Uterine Niche Clinical Trial

Official title:

Comparison the Effect of Uterine Closure Technique Difference on Uterine Niche After Caesarean Delivery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04799457
• Other study ID #: 2021/0077
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: March 2021
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: Ergul Demircivi Bor
• Phone: +902166065200
• Email: drergul[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Closure; Incomplete, Uterus
• Uterine Niche

Intervention

Other:
• Suture technique
We wil apply additional sutures to classical caesarean procedure.

Locations

Country	Name	City	State
Turkey	Prof Dr Suleyman Yalcin Goztepe City Hospital	Istanbul	Kadikoy

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Bennich G, Rudnicki M, Wilken-Jensen C, Lousen T, Lassen PD, Wøjdemann 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: 10.1 — View 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 — View 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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants for each group for study	We will try to reach fifty participants for each group (study group as classical cesarean with supporting suture and control group as classical cesarean) . When we reach to all participants we will stop to enroll the participants.	Up to 9 months