Cesarean Section; DehiscenceNCT03140683
Predictors of Scar Dehiscence in Patients With Previous Caesarean Section
An observational study of Cesarean Section; Dehiscence, run by Assiut University at 1 site in Egypt.
Trial summary
In recent decades, the percentage of Cesarean section deliveries has dramatically increased in most countries. Concomitantly, the rates of vaginal birth after Cesarean have decreased steadily. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section; Dehiscence
- What is being tested?
- non-stress test
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Study sample will be collected from Women's Health Hospital of Assiut University and Assuit Health Insurance Hospital
Who may be able to join
- Pregnant full-term 37-42 weeks.
- Previous one caesarean section
Who cannot join
- Absolute indication of cesarean section in previous and in current pregnancy
- Pregnant women with Hemoglobin <9
- Pregnant women with bleeding tendency
- Pregnant women with collagen disease
- Pregnant women with pre-eclampsia and eclampsia
- Pregnant women with gestational diabetes
- Multiple pregnancy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut Faculty of Medicine
Asyut
Ahmed Abbas, MD, 01003385183, bmr90@hotmail.com
About this study
Official title: Predictors of Scar Dehiscence in Patients With Previous Caesarean Section; a Study of Different Variables Tenderness Versus Non-stress Test
In recent decades, the percentage of Cesarean section deliveries has dramatically increased in most countries. Concomitantly, the rates of vaginal birth after Cesarean have decreased steadily.
The pregnant women with previous Cesarean section face a difficult choice for their next delivery between a trial of labor after Cesarean or repeat caesarean section delivery.
Read more
The performance of multiple Cesarean section exposes women to greater risks of complications; furthermore, the risk of complications increases with each subsequent Cesarean section.
In fact, women with previous Cesarean section are more likely to experience short and long-term maternal complications in future pregnancies, or a trial of labor after Cesarean, with the risk of [uterine dehiscence, uterine rupture, genitourinary tract damage, hemorrhage and hysterectomy, abnormal placentation (placenta previa and placenta accreta) and difficulties during surgery
- Conditions
- Cesarean Section; Dehiscence
- Being tested
- non-stress test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-stress testDevice
antepartum fetal monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
number of women with dehisensce scar and Non-stress test abnormalities
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start1 Jun 2017
- Primary completionSep 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; DehiscenceStudies 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
- Prospective
- Enrolment
- 180 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
- NCT03140683
- Sponsor's protocol ID
- SDCS
- Status last verified
- Jun 2018
- First submitted
- 3 May 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
- Predictors of Scar Dehiscence in Patients With Previous Caesarean Section; a Study of Different Variables Tenderness Versus Non-stress Test
- ClinicalTrials.gov ID
- NCT03140683
- Acronym / sponsor ID
- SDCS
- Conditions
- Cesarean Section; Dehiscence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 4 May 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.
In recent decades, the percentage of Cesarean section deliveries has dramatically increased in most countries. Concomitantly, the rates of vaginal birth after Cesarean have decreased steadily.
The pregnant women with previous Cesarean section face a difficult choice for their next delivery between a trial of labor after Cesarean or repeat caesarean section delivery.
The performance of multiple Cesarean section exposes women to greater risks of complications; furthermore, the risk of complications increases with each subsequent Cesarean section.
In fact, women with previous Cesarean section are more likely to experience short and long-term maternal complications in future pregnancies, or a trial of labor after Cesarean, with the risk of [uterine dehiscence, uterine rupture, genitourinary tract damage, hemorrhage and hysterectomy, abnormal placentation (placenta previa and placenta accreta) and difficulties during surgery
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Study sample will be collected from Women's Health Hospital of Assiut University and Assuit Health Insurance Hospital
Key inclusion criteria (2 listed)
- Pregnant full-term 37-42 weeks.
- Previous one caesarean section
Key exclusion criteria (7 listed)
- Absolute indication of cesarean section in previous and in current pregnancy
- Pregnant women with Hemoglobin <9
- Pregnant women with bleeding tendency
- Pregnant women with collagen disease
- Pregnant women with pre-eclampsia and eclampsia
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 |
|---|---|---|
| non-stress testantepartum fetal monitoring | Device | – |
Primary outcome
number of women with dehisensce scar and Non-stress test abnormalities
Time frame: 6 hours
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
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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.
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; Dehiscence, 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 7 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of women with dehisensce scar and Non-stress test abnormalities (time frame: 6 hours). 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.