Abdominal AdhesionNCT06164522
Prediction of Intraoperative Adhesions Before CS
An observational study of Abdominal Adhesion, run by Assiut University.
Trial summary
To predict the presence of intra-abdominal adhesions among women undergoing repeated cesarean section using several parameters. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Abdominal Adhesion
- What is being tested?
- Abdominal ultrasound
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Adult
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
Who may be able to join
- Pregnant women aged from 18 to 35 years
- Women with at least one previous C-section
- Gestational age (≥36 weeks)
- Planned elective cesarean section
Who cannot join
- primigravida
- Gestational age (<36 weeks)
- Pregnant woman who had developed wound site infections following prior cesarean section
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prediction of Intraoperative Adhesions Before Cesarean Section: Integrating Parameters From History, Examination, and Investigations
To predict the presence of intra-abdominal adhesions among women undergoing repeated cesarean section using several parameters.
Read the 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.
- Conditions
- Abdominal Adhesion
- Being tested
- Abdominal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal ultrasoundOther
Abdominal ultrasound to detect sliding sign
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From January 2024 to February 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Abdominal AdhesionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Ahmed Essa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164522
- Sponsor's protocol ID
- Intraoperative adhesions
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 29415600Mokhtari 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.
PubMed 36128300Piessens 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.
PubMed 31493569Awonuga 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.
PubMed 21775773Dogan 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.
PubMed 21306338
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Intraoperative Adhesions Before Cesarean Section: Integrating Parameters From History, Examination, and Investigations
- ClinicalTrials.gov ID
- NCT06164522
- Acronym / sponsor ID
- Intraoperative adhesions
- Conditions
- Abdominal Adhesion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- Pregnant women aged from 18 to 35 years
- Women with at least one previous C-section
- Gestational age (≥36 weeks)
- Planned elective cesarean section
Key exclusion criteria (3 listed)
- primigravida
- Gestational age (<36 weeks)
- Pregnant woman who had developed wound site infections following prior cesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal ultrasoundAbdominal ultrasound to detect sliding sign | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Background: PubMed 29415600Shenhav 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.
- Background: PubMed 36128300Mokhtari 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.
- Background: PubMed 31493569Piessens 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.
- Background: PubMed 21775773Awonuga 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.
- Background: PubMed 21306338Dogan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Adhesion, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Mahmoud Ahmed Essa, Doctor (01008235474, ahmedessa678@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predicting presence of intra-abdominal adhesions among women undergoing repeated cesarean section using several parameters. (time frame: From January 2024 to February 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06164522, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.