Primary Cesarean SectionNCT06083727
Primary Cesarean Section in Primigravida and Muligravida in Sohag and Al Balyana Cities
An observational study of Primary Cesarean Section, run by Sohag University at 1 site in Egypt.
Trial summary
cesarean section and vaginal delivery are two methods of delivery, cesarean section somtimes indicated for obstetrical reason but primary cesarean section especially in primigravida might have a preference of the mode of delivery Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Primary Cesarean Section
- What is being tested?
- rate of cesarean section
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Sep 2023to 24 Mar 2024
- 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 45 years
- Women only
- Adult
Study population: all primigravida with gestational age more than 28 weeks and above who have come for delivery * multigravida upto gravida 4 with gestational age more than 28 weeks and above who has had one previous viable vaginal delivery * women between 18 and 45 years
Who may be able to join
- all primigravida with gestational age more than 28 weeks and above who have come for delivery
- multigravida upto gravida 4 with gestational age more than 28 weeks and above who has had one previous viable vaginal delivery
- women between 18 and 45 years
Who cannot join
- primigravida women <28 weeks
- multigravida <28 weeks
- patient having previous history of myomectomy or hystrotomy
- gravida 5 and more
Trial locations and contacts
1 site in 1 country.
Salah M Rasheed, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university
Sohag, Sohag
Magdy M Amin, professor, PORTAL@MED.SOHAG.EDU.EG
About this study
cesarean section and vaginal delivery are two methods of delivery, cesarean section somtimes indicated for obstetrical reason but primary cesarean section especially in primigravida might have a preference of the mode of delivery
- Conditions
- Primary Cesarean Section
- Being tested
- rate of cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rate of cesarean sectionOther
rate of primary cesarean section in primigravida and multigravida
| Study group | Role | What they receive |
|---|---|---|
| primigravida | Not described Receives: Other: rate of cesarean section | |
| multigravida | Not described Receives: Other: rate of cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate
rate of primary cesarean section
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start24 Sep 2023
- Primary completion24 Mar 2024 (estimated)
- Study completion24 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Nasser Fathy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083727
- Sponsor's protocol ID
- Soh-Med-23-09-03MS
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Cesarean Section in Primigravida and Muligravida in Sohag and Al Balyana Cities
- ClinicalTrials.gov ID
- NCT06083727
- Acronym / sponsor ID
- Soh-Med-23-09-03MS
- Conditions
- Primary Cesarean Section
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 24 Sep 2023 (actual)
- Primary completion
- 24 Mar 2024 (estimated)
- Study completion
- 24 Mar 2024 (estimated)
- First posted
- 16 Oct 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.
cesarean section and vaginal delivery are two methods of delivery, cesarean section somtimes indicated for obstetrical reason but primary cesarean section especially in primigravida might have a preference of the mode of delivery
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primigravida | – | Other: rate of cesarean section |
| multigravida | – | Other: rate of cesarean section |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- all primigravida with gestational age more than 28 weeks and above who have come for delivery * multigravida upto gravida 4 with gestational age more than 28 weeks and above who has had one previous viable vaginal delivery * women between 18 and 45 years
Key inclusion criteria (3 listed)
- all primigravida with gestational age more than 28 weeks and above who have come for delivery
- multigravida upto gravida 4 with gestational age more than 28 weeks and above who has had one previous viable vaginal delivery
- women between 18 and 45 years
Key exclusion criteria (4 listed)
- primigravida women <28 weeks
- multigravida <28 weeks
- patient having previous history of myomectomy or hystrotomy
- gravida 5 and more
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 |
|---|---|---|
| rate of cesarean sectionrate of primary cesarean section in primigravida and multigravida | Other | multigravida, primigravida |
Primary outcome
rate
Time frame: 6 months
rate of primary cesarean section
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
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Not yet recruiting
Prophylactic Regimen of Intravenous Oxytocin, Intravenous Tranexamic Acid, and Intramuscular Ergot Derivative for Primary Prevention of Postpartum Hemorrhage in Intrapartum Cesarean Section Versus Intravenous Carbetocin Alone
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Effect of Extracellular Calcium on Carbetocin Mediated Contractility in Human Myometrium
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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.
Salah M Rasheed, professor 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 Primary Cesarean Section, run by Sohag 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 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 16 Oct 2023. 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 Sahar N Fathy, resident (01146577899, sahernasser@med.sohag.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate (time frame: 6 months). 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 16 Oct 2023.