Vaginal DeliveryNCT06680804
Factors Affecting Success of Vaginal Birth After Cesarean Section
An observational study of Vaginal Delivery, run by Sohag University.
Trial summary
Factors affecting Success of Vaginal Birth After Cesarean Section in Sohag University Hospitals Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Vaginal Delivery
- What is being tested?
- chance for vaginal delivery.
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- Women only
- Adult
Study population: All patients admitted for vaginal delivery with previous lower segment cesarean section . Age from 20 to 40 years.Time interval more than 1.5 years from previous caesarean section.
Who may be able to join
- • Age from 20 to 40 years.
- Time interval more than 1.5 years from previous caesarean section.
- Single viable full-term pregnancy in vertex presentation.
- Reactive cardiotocography (CTG) on admission.
- Spontaneous labor onset.
- Clinically adequate pelvis.
- Single fetus
- Average AFI fetus
Who cannot join
- • Women with previous upper segment cesarean section or hysterotomy scar.
- Any obstetric complications such as fetal malpresentation, placenta previa, or medical disorders like diabetes mellitus or preeclampsia.
- Presence of any signs and symptoms of scar dehiscence or ruptured uterus, known uterine fibroid or anomaly.
- Suspected fetal macrosomia (weight more than 4 kg).
- Multifetal pregnancy.
- Parturient women who refused the trial of vaginal birth after caesarean section.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Factors Affecting Success of Vaginal Birth After Cesarean Section in Sohag University Hospitals
Factors affecting Success of Vaginal Birth After Cesarean Section in Sohag University Hospitals
Read the detailed description
- Clinical data will be collected from the participants including demographic details such as age, maternal age, parity, BMI, gestational age based on last menstrual period or early ultrasound scans available.
- Full medical and surgical history, previous CS details as an indication, and previous complications.
- Patients' clinical abdominal and per vaginal examination on admission (cervical dilatation, effacement head station, and position).
- CTG attached on admission (to exclude fetal distress).
- Laboratory investigations that will be done before delivery and postpartum, Labor progress on the partogram will be assessed as regard duration of both first and second stages of labor if any instrumental delivery will be done.
- Radiology investigations such as US.
- Records for patients' vital signs, fetal cardiac activity during labor, vaginal bleeding, delivery notes, fetal weight, and 5 minutes APGAR score, and any recorded maternal or fetal complications.
- If failed VBAC: Causes of failure maternal and fetal outcomes will be recorded and immediate CS to be done
- Conditions
- Vaginal Delivery
- Being tested
- chance for vaginal delivery.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chance for vaginal delivery.Other
chance for vaginal delivery in patients who had delivered by Caesarean section in first pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Group I: Successful VBAC group | Successful VBAC group whose take chance for vaginal delivery. Receives: Other: chance for vaginal delivery. | |
| Group II: Failed VBAC group | Failed VBAC group whose take chance for vaginal delivery. Receives: Other: chance for vaginal delivery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful vaginal delivery
successful vaginal delivery in patients who had delivered by Caesarean section in first pregnancy
Measured: From November 2024 to April 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DeliveryStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Rashwan Ezz-eldine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680804
- Sponsor's protocol ID
- soh-Ned-15-10_9MS
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- 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 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Success of Vaginal Birth After Cesarean Section in Sohag University Hospitals
- ClinicalTrials.gov ID
- NCT06680804
- Acronym / sponsor ID
- soh-Ned-15-10_9MS
- Conditions
- Vaginal Delivery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 8 Nov 2024 (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.
Factors affecting Success of Vaginal Birth After Cesarean Section in Sohag University Hospitals
Detailed description
- Clinical data will be collected from the participants including demographic details such as age, maternal age, parity, BMI, gestational age based on last menstrual period or early ultrasound scans available.
- Full medical and surgical history, previous CS details as an indication, and previous complications.
- Patients' clinical abdominal and per vaginal examination on admission (cervical dilatation, effacement head station, and position).
- CTG attached on admission (to exclude fetal distress).
- Laboratory investigations that will be done before delivery and postpartum, Labor progress on the partogram will be assessed as regard duration of both first and second stages of labor if any instrumental delivery will be done.
- Radiology investigations such as US.
- Records for patients' vital signs, fetal cardiac activity during labor, vaginal bleeding, delivery notes, fetal weight, and 5 minutes APGAR score, and any recorded maternal or fetal complications.
- If failed VBAC: Causes of failure maternal and fetal outcomes will be recorded and immediate CS to be done
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: Successful VBAC group | – | Other: chance for vaginal delivery.Successful VBAC group whose take chance for vaginal delivery. |
| Group II: Failed VBAC group | – | Other: chance for vaginal delivery.Failed VBAC group whose take chance for vaginal delivery. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- All patients admitted for vaginal delivery with previous lower segment cesarean section . Age from 20 to 40 years.Time interval more than 1.5 years from previous caesarean section.
Key inclusion criteria (8 listed)
- • Age from 20 to 40 years.
Key exclusion criteria (6 listed)
- • Women with previous upper segment cesarean section or hysterotomy scar.
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 |
|---|---|---|
| chance for vaginal delivery.chance for vaginal delivery in patients who had delivered by Caesarean section in first pregnancy | Other | Group I: Successful VBAC group, Group II: Failed VBAC group |
Primary outcome
successful vaginal delivery
Time frame: From November 2024 to April 2025
successful vaginal delivery in patients who had delivered by Caesarean section in first pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Delivery, run by Sohag 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 8 inclusion and 6 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: opening soon, as of the sponsor's last update on 8 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nahla Rashwan ezzeldine, master (01013774970, nashwa_rashwan_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful vaginal delivery (time frame: From November 2024 to April 2025). 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 8 Nov 2024.