Clinical trial NCT06164522: Prediction of Intraoperative Adhesions Before CS
Official title: Prediction of Intraoperative Adhesions Before Cesarean Section: Integrating Parameters From History, Examination, and Investigations
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Abdominal Adhesion
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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

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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Predicting presence of intra-abdominal adhesions among women undergoing repeated cesarean section using several parameters.
timeFrame: From January 2024 to February 2025
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.