- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06164522
Prediction of Intraoperative Adhesions Before CS
Prediction of Intraoperative Adhesions Before Cesarean Section: Integrating Parameters From History, Examination, and Investigations
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
One of the most frequently performed surgical procedures globally is cesarean delivery (CD). Cesarean delivery rate is increasing, which raises the prevalence of intra-abdominal adhesions . The rate of intra-abdominal adhesions is 24-83% . Adhesions cause various postoperative complications, including intestinal obstruction, pelvic pain, dyspareunia, infertility, visceral injury, delayed delivery of the newborn , prolong surgical duration, increase bleeding amount and the incidence of hysterectomy . For these reasons, obstetricians always want to identify the possible extent of adhesions before cesarean section. Although to date there was no reliable technique to predict adhesions in women undergoing repeat CD .
Methods used in the evaluation of adhesions include the previous cesarean scar features, pigmentation, width and length , ultrasound sliding sign has been used in predicting pelvic endometriosis ,Baron et al. ,used the sliding sign in predicting adhesions in women undergoing repeat CD, also Stretch marks are a type of skin alteration that occur during pregnancy.
To ensure better surgical outcomes and reduce morbidities, the accurate prediction of adhesion formations before cesarean section is important. This study aims to investigate the integration of multiple parameters, such as evaluating cesarean scars, ultrasound sliding sign, and striae gravidarum, to assess intra-abdominal adhesions. We hypothesize that employing a combination of these parameters will yield superior predictive capabilities compared to relying on a single parameter alone. By exploring a comprehensive approach to adhesion prediction, we endeavor to enhance the safety and efficacy of cesarean section procedures, ultimately improving maternal and fetal well-being.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ahmed Mahmoud Ahmed Essa, Doctor
- Phone Number: 01008235474
- Email: ahmedessa678@yahoo.com
Study Contact Backup
- Name: Diaa El deen Mohammed Abd-Elaal El-Nashar, Professor
- Phone Number: 01005212137
- Email: Abdelaald@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
- Pregnant women aged from 18 to 35 years
- Women with at least one previous C-section
- Gestational age (≥36 weeks)
- Planned elective cesarean section
Description
Inclusion Criteria:
- Pregnant women aged from 18 to 35 years
- Women with at least one previous C-section
- Gestational age (≥36 weeks)
- Planned elective cesarean section
Exclusion Criteria:
- primigravida
- Gestational age (<36 weeks)
- Pregnant woman who had developed wound site infections following prior cesarean section
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Predicting presence of intra-abdominal adhesions among women undergoing repeated cesarean section using several parameters.
Time Frame: From January 2024 to February 2025
|
Detection of intra-operative adhesions before repeated cesarean section by history, examination and ultrasound
|
From January 2024 to February 2025
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Intraoperative adhesions
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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