NCT05770115

Brief Summary

The first group patients underwent double layer closure with split thickness with vicryl 2/0, in continuous, non- locked, 1 cm apart sutures, study group, and the second group, women underwent double layer closure with split thickness with vicryl 1, in continuous, non- locked, 1 cm apart sutures, control group. Then, all women in the study were followed up for development of niche within 1 to 6 weeks. The assessment after one week postpartum was with using trans-abdominal Ultrasound, then after two to six weeks postpartum with transvaginal Ultrasound

Trial Health

87
On Track

Trial Health Score

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

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2023

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

2.1 years

First QC Date

January 29, 2023

Last Update Submit

March 3, 2023

Conditions

Cesarean Section; Dehiscence

Outcome Measures

Primary Outcomes (1)

  • prevalence of uterine niche

    using transvaginal ultrasound for detection of development of CS scar niche

    6 weeks

Secondary Outcomes (4)

  • operative time

    1 hour

  • size of cs niche

    6 weeks

  • operative blood loss

    2 hours

  • postoperative haemoglobin

    24 hours

Study Arms (2)

Group A

EXPERIMENTAL

vicryl 2/0

Procedure: Vicryl 2/0

Group B

ACTIVE COMPARATOR

vicryl 1

Procedure: Vicryl 1

Interventions

Vicryl 1PROCEDURE

Double layer closure with split thickness with vicryl 1, in continuous, non-locked, 1 cm apart sutures.

Group B
Vicryl 2/0PROCEDURE

Double layer closure with split thickness with vicryl 2/0, in continuous, non-locked, 1 cm apart sutures.

Group A

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton term pregnancy.
  • Parity less than 5.
  • Women who undergo 1st cesarean section whether in labor or not.

You may not qualify if:

  • Women with a previous CS.
  • Previous major uterine surgery (e.g. laparoscopic or laparotomic fibroid resection, septum resection).
  • Women with known causes of menstrual disorders (e.g. cervical dysplasia, communicating hydro-salpinx, uterine anomaly or endocrine disorders disturbing ovulation).
  • Abnormally invasive placenta during the current pregnancy.
  • Multiple gestation, polyhydramnios.
  • Maternal Diabetes, anemia and connective tissue disorders.
  • Women with Body mass index \> 35.
  • Women with valval varicosities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy outpatient infertility clinic

Cairo, Egypt

Location

Related Publications (3)

  • Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199.

    PMID: 23996650BACKGROUND

  • Byrne M, Aly A. The Surgical Suture. Aesthet Surg J. 2019 Mar 14;39(Suppl_2):S67-S72. doi: 10.1093/asj/sjz036.

    PMID: 30869751BACKGROUND

  • 70. Monika & Gupta, Monika & Goraya, s.P.s & Kaur, Tanjeet & Matreja, Prithpal. (2017). Single Layer Versus Double Layer Closure of Uterus during Caesarean Section - A Prospective Study in Index and Subsequent Pregnancy. International Archives of BioMedical and Clinical Research. 1. 10.21276/iabcr.2017.3.1.14.

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

January 29, 2023

First Posted

March 15, 2023

Study Start

November 1, 2020

Primary Completion

December 15, 2022

Study Completion

February 10, 2023

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)