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

NCT ID: NCT04799457

Last Updated: 2021-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Uterine Niche Closure; Incomplete, Uterus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double Blinded Randomised Controlled Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
One study control person is organizing the whole trial and provides blinding to both sides (participants and care provider).

Study Groups

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Classical caesarean group

Care providers are applying standard caesarean procedure for participants.

Group Type NO_INTERVENTION

No interventions assigned to this group

Study caesarean group

Care providers are applying additional sutures to standard caesarean procedure for participants.

Group Type EXPERIMENTAL

Suture technique

Intervention Type OTHER

We wil apply additional sutures to classical caesarean procedure.

Interventions

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Suture technique

We wil apply additional sutures to classical caesarean procedure.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ergul Demircivi Bor

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ergul Demircivi Bor

Role: PRINCIPAL_INVESTIGATOR

Prof Dr Suleyman Yalcin Goztepe City Hospital

Locations

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Prof Dr Suleyman Yalcin Goztepe City Hospital

Istanbul, Kadikoy, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ergul Demircivi Bor

Role: CONTACT

+902166065200 ext. 360206

Facility Contacts

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Ergul Demircivi Bor

Role: primary

+902166065200

References

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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.

Reference Type RESULT
PMID: 26489989 (View on PubMed)

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.

Reference Type RESULT
PMID: 26522861 (View on PubMed)

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.

Reference Type RESULT
PMID: 24680843 (View on PubMed)

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.

Reference Type RESULT
PMID: 29215795 (View on PubMed)

Other Identifiers

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2021/0077

Identifier Type: -

Identifier Source: org_study_id

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