NCT04799457

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 5, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

March 5, 2021

Last Update Submit

March 11, 2021

Conditions

Uterine NicheClosure; Incomplete, Uterus

Keywords

nichecaesarean sectiontechniqueuterine closure

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Other: Suture technique

Interventions

Suture techniqueOTHER

We wil apply additional sutures to classical caesarean procedure.

Study caesarean group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis trial will be conducted at an obstetrics and gynecology clinic.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof Dr Suleyman Yalcin Goztepe City Hospital

Istanbul, Kadikoy, 34722, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • 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.

    PMID: 26489989RESULT

  • 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.

    PMID: 26522861RESULT

  • 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.

    PMID: 24680843RESULT

  • 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.

    PMID: 29215795RESULT

MeSH Terms

Interventions

Suture Techniques

Intervention Hierarchy (Ancestors)

Wound Closure TechniquesSurgical Procedures, Operative

Study Officials

  • Ergul Demircivi Bor

    Prof Dr Suleyman Yalcin Goztepe City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ergul Demircivi Bor

CONTACT

+902166065200drergul@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
One study control person is organizing the whole trial and provides blinding to both sides (participants and care provider).
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Double Blinded Randomised Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 16, 2021

Study Start

February 1, 2021

Primary Completion

July 31, 2021

Study Completion

October 31, 2021

Last Updated

March 16, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)