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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Classical caesarean group | No Intervention | Care providers are applying standard caesarean procedure for participants. | |
| Study caesarean group | Experimental | Care providers are applying additional sutures to standard caesarean procedure for participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suture technique | Other | We wil apply additional sutures to classical caesarean procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
This trial will be conducted at an obstetrics and gynecology clinic.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ergul Demircivi Bor | Contact | +902166065200 | 360206 | drergul@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Ergul Demircivi Bor | Prof Dr Suleyman Yalcin Goztepe City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof Dr Suleyman Yalcin Goztepe City Hospital | Recruiting | Istanbul | Kadikoy | 34722 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26489989 | Result | 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. | |
| 26522861 | Result | 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. |
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| ID | Term |
|---|---|
| D013536 | Suture Techniques |
| ID | Term |
|---|---|
| D058106 | Wound Closure Techniques |
| D013514 | Surgical Procedures, Operative |
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Double Blinded Randomised Controlled Trial
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One study control person is organizing the whole trial and provides blinding to both sides (participants and care provider).
| 24680843 | Result | 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. |
| 29215795 | Result | 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. |