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CompletedNCT05100147Updated Oct 7, 2026

Uterine Closure Techniques and Cesarean Scar Defect Risk

An interventional study of Uterine closure during Cesarean section in Cesarean Section Complications and Scar; Deformity, sponsored by Mersin University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Mersin University · Not applicable, Interventional, and Treatment

Updated Oct 7, 2026First site in Turkey (Türkiye)No longer in Turkey+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

Cesarean operations are one of the most common obsetric operations and have an increasing trend in all over the world. However unfortunately the operation techniques have not been standardized yet. It is well known that different uterine closure techniques result in differences with respect to wound healing on the uterus; however, the ideal uterine closure technique is yet not known. The aim of this study is to assess the results of different uterine closure techniques during cesarean section with respect to the development of cesarean scar defects.

Read the detailed description

Patients were randomized into three groups using a computer-based program (ratio 1:1:1), and the assigned surgical technique was disclosed just before surgery. At the time of surgery, the sealed opaque envelope, numbered consecutively and containing the description of the suturation technique, was given to the operator. Suturing techniques varied between groups: double layer continuous, non-locking suturing with endometrial inclusion, second layer imbricating the first layer (Group 1), double layer, continuous, non-locking suturing without endometrial inclusion second layer imbricating the first layer (Group 2) and double layer continuous with the first layer unlocked, including the endometrium and the deep part of the myometrium, and the second layer continuous unlocked including the remaining part of the myometrium (Group 3). Size 1 polyglycolic acid 910 (Vicryl ® Ethicon Inc. Somerville, NJ) was used as suture material in all groups.

Patients were re-evaluated at the sixth month as uterine scar healing is reported to be completed within six months and preoperative assessments were repeated. Transvaginal ultrasonography was performed by an investigator blinded to suturing techniques. Measurements included RMT, and CSD assessment (as the primary outcomes) (including the depth and width of the CSD), as well as other routine ultrasonographic evaluations. Transvaginal sonography was performed by the same investigator with a Toshiba Applio 500 device using a PMW-621VT 6 Mhz R13 probe. CSD was considered when myometrial continuity in the previous caesarean incision site was lost, and an anechoic defective area towards the myometrium was noted. In patients who did not develop CSD, the incision line was measured anteriorly, and the symmetrical posterior uterine wall thickness was measured. In patients with CSD, the myometrium tissue above the anechoic defective area was evaluated as residual myometrial thickness. The CSD sac's depth and its base's width were measured. The full-thickness myometrium adjacent to the defect area was measured, and recovery rates were calculated by taking the percentage of the residual myometrial thickness over the defect to the full-thickness myometrium.

02

Conditions studied

  • Cesarean Section Complications
  • Scar; Deformity

Keywords

  • cesarean scar defect
  • cesarean section
  • uterine closure techniques
03

In context

Cicatrix

307 studies on the registry are indexed under Cicatrix; 50 are open to participants now.

This study's enrollment of 43 is above the median of 39 across 251 interventional studies indexed under Cicatrix.

Browse Cicatrix studies →

Lead sponsor

Mersin University is the lead sponsor of 173 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. being nulliparous
  2. having singleton fetus
  3. not having diabetes and or hypertension
  4. not having an intrauterine infection
  5. body mass index \<35 kg/m2
  6. not having any placental insertion anomalies
  7. not having Mullerian anomalies
  8. active phase of labor is not started.
  9. no previous uterine surgeries

Exclusion criteria

Exclusion Criteria:

  1. being multiparous
  2. having multiple pregnancies
  3. having diabetes and or hypertension
  4. having an intrauterine infection
  5. body mass index >=35 kg/m2
  6. having any placental insertion anomalies
  7. having Mullerian anomalies
  8. in active phase of labor
  9. having previous uterine surgeries
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Group 1

    The uterotomy suture technique is continous, double layer suturing, in which the first layer is continuous and unlocked involving all uterine layers and a second, continuous non-locking imbrictating layer is applied over the first suture.

    Procedure: Uterine closure during Cesarean section

  • Experimental
    Group 2

    The uterotomy suture technique is continous, double layer suturing, in which the first layer is continuous and unlocked not including decidua and a second, continuous non-locking imbrictating layer is applied over the first suture.

    Procedure: Uterine closure during Cesarean section

  • Experimental
    Group 3

    The uterotomy suture technique is continous ,double layer with the first layer unlocked, excluding the decidua and including the deep part of the myometrium, and the second layer unlocked including the remaining part of the myometrium.

    Procedure: Uterine closure during Cesarean section

Interventions

  • ProcedureUterine closure during Cesarean section

    The uterotomy is sutured after the delivery of the fetus and the placenta with an appropriate delayed absorbable suture (number 1 polyglactin 910)

06

What researchers measure

Primary outcomes

  1. Residual myometrial thickness (RMT) at 6 months postpartum

    Residual myometrial thickness (RMT) will be assessed by transvaginal ultrasonography at 6 months postpartum. The measurement will be performed at the site of the previous cesarean incision. Three measurements will be obtained from different ultrasound images, and the mean value will be calculated.

    Time frame: 6 months postpartum

Secondary outcomes

  1. Presence of cesarean scar defect (CSD) at 6 months postpartum

    The presence of a cesarean scar defect (CSD) will be assessed by transvaginal ultrasonography at 6 months postpartum. CSD will be defined as a discontinuity of the myometrial layer at the site of the previous cesarean incision, with an anechoic defect extending into the myometrium.

    Time frame: 6 months postpartum

07

Study locations

1 site
  • Mersin University Hospital
    Mersin, Mersin 33170, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
1 site added, 1 site removed — first site in Turkey (Türkiye); no longer in Turkey
Show site
  • Mersin University Hospital · Mersin, Turkey (Türkiye)
Show 1 removed
  • Mersin University Hospital · Mersin, Turkey
Oct 7, 2026
Also revised
primary outcomes
Show all 1 update
  1. Oct 7, 2026
    1 site added, 1 site removed — first site in Turkey (Türkiye); no longer in Turkey
    Show site
    • Mersin University Hospital · Mersin, Turkey (Türkiye)
    Show 1 removed
    • Mersin University Hospital · Mersin, Turkey
    Primary outcomes Revised (3 changes)
    + 3 other changes: index terms, description and secondary outcomes

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05100147
Lead sponsor
Mersin University
Responsible party
Hakan Aytan (Prof. Dr. Hakan Aytan, Mersin University) — Principal investigator
First posted
Oct 29, 2021
Start date
Nov 1, 2021
Primary completion
May 31, 2022
Completion
May 31, 2022
Last update
Oct 7, 2026

Study contacts

Ezgi Oktay, MD
study chair · Mersin University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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