Vaginal DeliveryNCT07075848
Outcomes of Delivery in Primigravida
An observational study of Vaginal Delivery, run by Assiut University.
Trial summary
Primigravida women are a high-priority population due to their increased risk of obstetric interventions and adverse outcomes compared to multiparous women. Research indicates that first-time mothers account for a disproportionate number of emergency cesarean sections and instrumental deliveries, often due to factors… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vaginal Delivery
- What is being tested?
- vaginal delivery
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Jan 2028
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primigravida come in labour
Who may be able to join
- Primigravida women admitted for delivery at the hospital
- Singleton pregnancies.
- Gestational age ≥ 28 weeks (to exclude preterm deliveries before viability).
- Willingness to participate.
Who cannot join
- • Multiparous women.
- Multiple pregnancies.
- Women who decline to participate.
- Deliveries occurring outside the specified study period.
About this study
Official title: Study of Outcomes of Delivery in Primgravida
Primigravida women are a high-priority population due to their increased risk of obstetric interventions and adverse outcomes compared to multiparous women. Research indicates that first-time mothers account for a disproportionate number of emergency cesarean sections and instrumental deliveries, often due to factors such as inadequate labor support or failure to progress
Read the detailed description
The significance of auditing delivery care for primigravida women lies in their heightened vulnerability to complications such as prolonged labor, fetal distress, and higher rates of cesarean sections. Studies have shown that primigravida women often experience higher levels of fear and anxiety related to childbirth, which can influence their labor progression and overall birth experience. By systematically evaluating the care provided to this group, healthcare institutions can implement targeted interventions to enhance outcomes and patient satisfaction.
- Conditions
- Vaginal Delivery
- Being tested
- vaginal delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal deliveryProcedure or surgery
follow up of progress of labour
| Study group | Role | What they receive |
|---|---|---|
| study group | Not described Receives: Procedure: vaginal delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of vaginal delivery in cases
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Jan 2028 (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 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salah Gobara, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075848
- Sponsor's protocol ID
- PGDA
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Outcomes of Delivery in Primgravida
- ClinicalTrials.gov ID
- NCT07075848
- Acronym / sponsor ID
- PGDA
- Conditions
- Vaginal Delivery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 20 Jul 2025 (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.
Primigravida women are a high-priority population due to their increased risk of obstetric interventions and adverse outcomes compared to multiparous women. Research indicates that first-time mothers account for a disproportionate number of emergency cesarean sections and instrumental deliveries, often due to factors such as inadequate labor support or failure to progress
Detailed description
The significance of auditing delivery care for primigravida women lies in their heightened vulnerability to complications such as prolonged labor, fetal distress, and higher rates of cesarean sections. Studies have shown that primigravida women often experience higher levels of fear and anxiety related to childbirth, which can influence their labor progression and overall birth experience. By systematically evaluating the care provided to this group, healthcare institutions can implement targeted interventions to enhance outcomes and patient satisfaction.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Procedure: vaginal delivery |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primigravida come in labour
Key inclusion criteria (4 listed)
- Primigravida women admitted for delivery at the hospital
- Singleton pregnancies.
- Gestational age ≥ 28 weeks (to exclude preterm deliveries before viability).
- Willingness to participate.
Key exclusion criteria (4 listed)
- • Multiparous women.
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 deliveryfollow up of progress of labour | Procedure or surgery | study group |
Primary outcome
The rate of vaginal delivery in cases
Time frame: 24 hours
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 24 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Delivery, run by Assiut 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 4 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: opening soon, as of the sponsor's last update on 24 Jul 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of vaginal delivery in cases (time frame: 24 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 24 Jul 2025.