Cesarean Section ComplicationsNCT03261765
Effect of Multiple Repeat Cesarean Sections on Intra-abdominal Adhesions
An observational study of Cesarean Section Complications, run by Assiut University at 1 site in Egypt.
Trial summary
The rate of cesarean section deliveries has increased dramatically worldwide in the last decades. While the cesarean birth rate was 4.5% in the USA in 1965, it was 31.8% according to 2007 data and is thought to be over 50% at present. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Assessment of adhesions
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to Nov 2018
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: All women with repeated cesarean section
Who may be able to join
- Women with at least previous one cesarean section.
- Women accepted to participate in the study.
Who cannot join
- Previous abdominopelvic surgery other than cesarean section.
- History of Pelvic inflammatory disease.
- Women refuse to participate in the study.
- Intrauterine fetal death
Trial locations and contacts
1 site in 1 country.
Ahmed Abbas contact
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Abbas
Assiut, Cairo Governorate, 002
ahmed abbas, bmr90@hotmail.com
About this study
The rate of cesarean section deliveries has increased dramatically worldwide in the last decades. While the cesarean birth rate was 4.5% in the USA in 1965, it was 31.8% according to 2007 data and is thought to be over 50% at present. The reasons for this include advanced age of primigravida, a wide range of indications, patient requests, the frequency of women with previous cesareans, women's rejections to offers of sterilization, and the common usage of assisted reproductive techniques
- Conditions
- Cesarean Section Complications
- Being tested
- Assessment of adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of adhesionsOther
Modified Nair scoring system
| Study group | Role | What they receive |
|---|---|---|
| Multiple repeat cesarean (four or more) | Not described Receives: Other: Assessment of adhesions | |
| Fewer repeat cesarean (two-three) | Not described Receives: Other: Assessment of adhesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of abdominal adhesions
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start1 Jun 2018
- Primary completionAug 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261765
- Sponsor's protocol ID
- CSIAA
- Status last verified
- Jun 2018
- First submitted
- 23 Aug 2017
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multiple Repeat Cesarean Sections on Intra-abdominal Adhesions
- ClinicalTrials.gov ID
- NCT03261765
- Acronym / sponsor ID
- CSIAA
- Conditions
- Cesarean Section Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 25 Aug 2017 (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.
The rate of cesarean section deliveries has increased dramatically worldwide in the last decades. While the cesarean birth rate was 4.5% in the USA in 1965, it was 31.8% according to 2007 data and is thought to be over 50% at present. The reasons for this include advanced age of primigravida, a wide range of indications, patient requests, the frequency of women with previous cesareans, women's rejections to offers of sterilization, and the common usage of assisted reproductive techniques
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple repeat cesarean (four or more) | – | Other: Assessment of adhesions |
| Fewer repeat cesarean (two-three) | – | Other: Assessment of adhesions |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All women with repeated cesarean section
Key inclusion criteria (2 listed)
- Women with at least previous one cesarean section.
- Women accepted to participate in the study.
Key exclusion criteria (4 listed)
- Previous abdominopelvic surgery other than cesarean section.
- History of Pelvic inflammatory disease.
- Women refuse to participate in the study.
- Intrauterine fetal death
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 |
|---|---|---|
| Assessment of adhesionsModified Nair scoring system | Other | Fewer repeat cesarean (two-three), Multiple repeat cesarean (four or more) |
Primary outcome
Rate of abdominal adhesions
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Recruiting
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Not yet recruiting
Effect of Stress Ball Use on Perioperative Anxiety and Postoperative Pain in Parturients Undergoing Cesarean Section
Postoperative Pain
Not yet recruiting
Effect of Sacral Erector Spinae Plane Block on Quality of Recovery After Cesarean Delivery: A Prospective Randomized Controlled Trial
Pain, Postoperative Pain
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.
Ahmed Abbas contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Complications, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 4 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 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Abbas (01003385183, bmr90@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of abdominal adhesions (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2018.