NCT06164522

Brief Summary

To predict the presence of intra-abdominal adhesions among women undergoing repeated cesarean section using several parameters.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

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

First Submitted

Initial submission to the registry

December 2, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

December 2, 2023

Last Update Submit

December 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Predicting presence of intra-abdominal adhesions among women undergoing repeated cesarean section using several parameters.

    Detection of intra-operative adhesions before repeated cesarean section by history, examination and ultrasound

    From January 2024 to February 2025

Interventions

Abdominal ultrasound to detect sliding sign

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

1. Pregnant women aged from 18 to 35 years 2. Women with at least one previous C-section 3. Gestational age (≥36 weeks) 4. Planned elective cesarean section

You may qualify if:

  • Pregnant women aged from 18 to 35 years
  • Women with at least one previous C-section
  • Gestational age (≥36 weeks)
  • Planned elective cesarean section

You may not qualify if:

  • primigravida
  • Gestational age (\<36 weeks)
  • Pregnant woman who had developed wound site infections following prior cesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Shenhav S, Grin L, Kapustian V, Anteby EY, Gdalevich M, Gemer O. Quantifying the effects of postcesarean adhesions on incision to delivery time. J Matern Fetal Neonatal Med. 2019 Aug;32(15):2500-2505. doi: 10.1080/14767058.2018.1439010. Epub 2018 Feb 20.

    PMID: 29415600BACKGROUND
  • Mokhtari M, Yaghmaei M, Akbari Jami N, Roudbari M, Jalalvand D. Prediction of Intraperitoneal Adhesions in Repeated Cesarean Section Using Sliding Sign, Striae Gravidarum, and Cesarean Scar. Med J Islam Repub Iran. 2022 May 2;36:44. doi: 10.47176/mjiri.36.44. eCollection 2022.

    PMID: 36128300BACKGROUND
  • Piessens S, Edwards A. Sonographic Evaluation for Endometriosis in Routine Pelvic Ultrasound. J Minim Invasive Gynecol. 2020 Feb;27(2):265-266. doi: 10.1016/j.jmig.2019.08.027. Epub 2019 Sep 4.

    PMID: 31493569BACKGROUND
  • Awonuga AO, Fletcher NM, Saed GM, Diamond MP. Postoperative adhesion development following cesarean and open intra-abdominal gynecological operations: a review. Reprod Sci. 2011 Dec;18(12):1166-85. doi: 10.1177/1933719111414206. Epub 2011 Jul 20.

    PMID: 21775773BACKGROUND
  • Dogan NU, Haktankacmaz SA, Dogan S, Ozkan O, Celik H, Eryilmaz OG, Doganay M, Gulerman C. A reliable way to predict intraabdominal adhesions at repeat cesarean delivery: scar characteristics. Acta Obstet Gynecol Scand. 2011 May;90(5):531-4. doi: 10.1111/j.1600-0412.2011.01080.x. Epub 2011 Mar 16.

    PMID: 21306338BACKGROUND

Central Study Contacts

Ahmed Mahmoud Ahmed Essa, Doctor

CONTACT

Diaa El deen Mohammed Abd-Elaal El-Nashar, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 2, 2023

First Posted

December 11, 2023

Study Start

January 1, 2024

Primary Completion

January 1, 2025

Study Completion

February 28, 2025

Last Updated

December 20, 2023

Record last verified: 2023-12