Cesarean SectionNCT03905980
Risk Factors for Primary Cesarean Section in Egypt
An observational study of Cesarean Section, run by Cairo University at 1 site in Egypt.
Trial summary
women in their first pregnancy evaluated till delivery for associated risk factors for cesarean delivery Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- vaginal delivery and Cesarean section
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2019to Jan 2020
- 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
- Healthy volunteers accepted
- Adult
Study population: woman carrying their first pregnancy
Who may be able to join
- women in their first pregnancy
- Delivery between 37 and 42 weeks
- Singleton pregnancy _ cephalic presentation
Who cannot join
- women asked for CS on demand
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy medical school
Cairo, 12151
Ahmed Maged, MD, 01005227404, prof.ahmedmaged@gmail.com
About this study
Official title: Evaluation of Risk Factors for Primary Cesarean Section in Egypt
women in their first pregnancy evaluated till delivery for associated risk factors for cesarean delivery
Read the detailed description
Evaluation of maternal , fetal, delivery place and health care provider rules to determine route of delivery in women during their first pregnancy
- Conditions
- Cesarean Section
- Being tested
- vaginal delivery, Cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal deliveryProcedure or surgery
pregnancy ended by vaginal delivery
Cesarean sectionProcedure or surgery
pregnancy ended by cesarean delivery
| Study group | Role | What they receive |
|---|---|---|
| Vaginal delivery | woman who terminate their pregnancy by vaginal delivery Receives: Procedure: vaginal delivery | |
| Cesarean delivery | woman who terminate their pregnancy by cesarean delivery Receives: Procedure: Cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
route of delivery in primigravida
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start30 Apr 2019
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905980
- Sponsor's protocol ID
- 56
- Status last verified
- Jul 2019
- First submitted
- 4 Apr 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Risk Factors for Primary Cesarean Section in Egypt
- ClinicalTrials.gov ID
- NCT03905980
- Acronym / sponsor ID
- 56
- Conditions
- Cesarean Section
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 8 Apr 2019 (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.
women in their first pregnancy evaluated till delivery for associated risk factors for cesarean delivery
Detailed description
Evaluation of maternal , fetal, delivery place and health care provider rules to determine route of delivery in women during their first pregnancy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal delivery | – | Procedure: vaginal deliverywoman who terminate their pregnancy by vaginal delivery |
| Cesarean delivery | – | Procedure: Cesarean sectionwoman who terminate their pregnancy by cesarean delivery |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- woman carrying their first pregnancy
Key inclusion criteria (3 listed)
- women in their first pregnancy
- Delivery between 37 and 42 weeks
- Singleton pregnancy _ cephalic presentation
Key exclusion criteria (1 listed)
- women asked for CS on demand
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 |
|---|---|---|
| vaginal deliverypregnancy ended by vaginal delivery | Procedure or surgery | Vaginal delivery |
| Cesarean sectionpregnancy ended by cesarean delivery | Procedure or surgery | Cesarean delivery |
Primary outcome
route of delivery in primigravida
Time frame: at delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Cesarean Section
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
Not yet recruitingPhase 4
Two Doses of IV Magnesium Sulfate for Prevention of Post-Spinal Shivering
Post Spinal Anesthesia Shivering
RecruitingObservational study
Respiratory Distress and Elective Cesarean Section at Term
Respiratory Distress Syndrome
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
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 Maged, MD principal investigator
Professor
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, run by Cairo 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 3 inclusion and 1 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 26 Jul 2019. 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 Maged, MD (+201005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
route of delivery in primigravida (time frame: at delivery). 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 26 Jul 2019.