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Completed

NCT Number: NCT03915847

Evaluation of Cesarean Scar After Three Different Uterine Closure Technis

The study compares three techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. Cesarean scar will be evaluated by transvaginal ultrasound six months after cesarean.

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Key information

Conditions

Cesarean Section, Repeated Cesarean, Residual Myometrial Thickness Cesarean, Uterine Scar Thickness

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University Hospital

Erzurum, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previous two or three cesarean
  • Gestational weeks >=36 weeks

Exclusion criteria

  • Risk of obstetric haemorrhage
  • Suspicion or diagnosis placenta previa or accrete syndrome
  • Chorioamnionitis
  • Uterine myoma in the anterior uterine segment
  • Hysterotomy other than lower segment uterine incision at previous cesarean

Treatment and study plan

Single layer closure

Procedure

Uterine incision will be approximated with continuous unlocked suture, including a narrow band of the endometrial layer, without trimming incision edges.

Double layer closure

Procedure

The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.

Doble layer closure with trimming

Procedure

Uterine incision will be trimmed and old scar tissue will be removed. The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.

Primary outcomes

  1. Residual myometrial thickness

    Time frame: 6 months after cesarean

    Myometrial thickness at the uterine scar by transvaginal ultrasound

Secondary outcomes

  1. Existence of cesarean scar defect

    Time frame: 6 months after cesarean

    The presence or absence of a cesarean scar defect that was defined as any unechogenic area visualised by transvaginal ultrasound at the site of the cesarean scar with a depth of at least 2 mm.

  2. Width of defect

    Time frame: 6 months after cesarean

    In a sagittal plane, the width at base of defect

  3. Depth of defect (niche)

    Time frame: 6 months after cesarean

    In a sagittal plane, the distance from the base lining of the endometrium to the apex

  4. Operation time

    Time frame: 10 minute after cesarean completed

    Skin-to-skin operation time

  5. Change in hemoglobin

    Time frame: 48 hours after cesarean

    Difference in haemoglobin measured preoperatively and postoperatively 48 hours

  6. Blood product transfusion

    Time frame: One week after cesarean

    Unite number of transfused packed erythrocyte

  7. Maternal infectious morbidity

    Time frame: Six weeks after cesarean

    Prevalence of postpartum endometritis, skin wound dehiscence and post operative fever.

  8. Length of hospitalization

    Time frame: One month after cesarean

    Duration in days

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Evaluation of Cesarean Scar After Three Different Uterine Closure Technis: A Randomised Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2019
Registry last updated
May 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.