Primigravida LabourNCT06784505
Obstetric Outcomes of Primigravidae
An observational study of Primigravida Labour, run by Assiut University.
Trial summary
To determine obstetric outcomes in primigravida at term at women's health centre Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Primigravida Labour
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Feb 2026
- 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 in labor satisfying the inclusion criteria
Who may be able to join
- Primigravida with singleton live fetus
- Cephalic presentation
- Delivered at term with gestational age(37 -41 weeks)
Who cannot join
- Multiparous women
- Multiple gestation
- Intra Uterine fetal death th (IUFD)
- Medical condition as preclampsia
- Polyhydramnios and fetal anomalies
- Malpresentation (e.g., breech, face).
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: Obstetric Outcomes of Primigravidae At Women's Health Centre; Cross Sectional Study
To determine obstetric outcomes in primigravida at term at women's health centre
Read the detailed description
A primigravida is a woman carrying her first pregnancy(.1)A woman carrying her first pregnancy is starting a new life and it is a crucial time in her obstetric career as subsequent obstetric performance will depend on how well the first pregnancy was managed.(2).Pregnancy in a primigravida is often viewed with anxiety not only by the patient who is going through the experience for the first time but also her relatives and her caregiver. The obstetric outcome of primigravidae is associated with many complications; therefore, they are considered high risk because of both maternal and fetal concerns(.2).Numerous studies have shown that primigravidae are at increased risk of complications during pregnancy, labor, and delivery and if not properly managed, these complications can result in increased morbidity and mortality for both the mother and baby(3) Reported complications include abnormal labor patterns, increased risk of operative deliveries, increased rate of admissions into neonatal intensive care unit and increased perinatal deaths.(4,5,6) The cardinal observation to be made in a gravid uterus at term in labor is engagement of head which is the initial step in the mechanism of labor. The term "engagement" in normal labor denotes that the greatest diameter of fetal head has passed through the brim of the pelvis.(7) Engaged head in a primigravida at term in early labor is a sign of pelvic adequacy.Unengaged head at the onset of labor is associated with increase in duration of labor and incidence of dysfunctional labor pattern.(8,9) Thus, undue prolongation of labor leads to increased risk of caesarean section(10,11) and its associated maternal and perinatal morbidity and mortality. The adequacy of the pelvis, the efficacy of uterine contractions, the capacity of fetal head to mold and the temperamental resilience of the patient contribute more to the outcome of labor. Hence, the dynamics of labor is equally important with mechanics as it improves the adaptation of fetal head To the pelvic cavity and its passage through it supported by primary and secondary forces of labor. Careful monitoring of progress of labor and timely medical intervention in these cases can reduce the incidence of caesarean deliveries. (11)This study will, therefore, assess the obstetric outcome of vaginal delivery of these women at term considering course \& duration of labour \& the incidence of complication with its associated fetomaternal outcomes
- Conditions
- Primigravida Labour
- Keywords
- Primigravidae
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal outcome
Maternal outcome woth respect to course of labour \& duration of first and second stage of labour
Measured: 10 hours
Secondary outcomes (1)
Progress of labour & neonatal outcome
Progress of labour in the respect of needing augmentation,mode of delivery \& labour complications Neonatal outcome in the respect of Apgar score, birth weight \& NICU admissions
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primigravida LabourStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menna Allah Abd Elaziaz Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784505
- Sponsor's protocol ID
- Outcomes in primigravidae
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 20 Jan 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 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstetric Outcomes of Primigravidae At Women's Health Centre; Cross Sectional Study
- ClinicalTrials.gov ID
- NCT06784505
- Acronym / sponsor ID
- Outcomes in primigravidae
- Conditions
- Primigravida Labour
- Keywords
- Primigravidae
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 20 Jan 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.
To determine obstetric outcomes in primigravida at term at women's health centre
Detailed description
A primigravida is a woman carrying her first pregnancy(.1)A woman carrying her first pregnancy is starting a new life and it is a crucial time in her obstetric career as subsequent obstetric performance will depend on how well the first pregnancy was managed.(2).Pregnancy in a primigravida is often viewed with anxiety not only by the patient who is going through the experience for the first time but also her relatives and her caregiver. The obstetric outcome of primigravidae is associated with many complications; therefore, they are considered high risk because of both maternal and fetal concerns(.2).Numerous studies have shown that primigravidae are at increased risk of complications during pregnancy, labor, and delivery and if not properly managed, these complications can result in increased morbidity and mortality for both the mother and baby(3) Reported complications include abnormal labor patterns, increased risk of operative deliveries, increased rate of admissions into neonatal intensive care unit and increased perinatal deaths.(4,5,6) The cardinal observation to be made in a gravid uterus at term in labor is engagement of head which is the initial step in the mechanism of labor. The term "engagement" in normal labor denotes that the greatest diameter of fetal head has passed through the brim of the pelvis.(7) Engaged head in a primigravida at term in early labor is a sign of pelvic adequacy.Unengaged head at the onset of labor is associated with increase in duration of labor and incidence of dysfunctional labor pattern.(8,9) Thus, undue prolongation of labor leads to increased risk of caesarean section(10,11) and its associated maternal and perinatal morbidity and mortality. The adequacy of the pelvis, the efficacy of uterine contractions, the capacity of fetal head to mold and the temperamental resilience of the patient contribute more to the outcome of labor. Hence, the dynamics of labor is equally important with mechanics as it improves the adaptation of fetal head To the pelvic cavity and its passage through it supported by primary and secondary forces of labor. Careful monitoring of progress of labor and timely medical intervention in these cases can reduce the incidence of caesarean deliveries. (11)This study will, therefore, assess the obstetric outcome of vaginal delivery of these women at term considering course \& duration of labour \& the incidence of complication with its associated fetomaternal outcomes
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primigravida in labor satisfying the inclusion criteria
Key inclusion criteria (3 listed)
- Primigravida with singleton live fetus
- Cephalic presentation
- Delivered at term with gestational age(37 -41 weeks)
Key exclusion criteria (6 listed)
- Multiparous women
- Multiple gestation
- Intra Uterine fetal death th (IUFD)
- Medical condition as preclampsia
- Polyhydramnios and fetal anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal outcome
Time frame: 10 hours
Maternal outcome woth respect to course of labour \& duration of first and second stage of labour
1 secondary outcome
Progress of labour & neonatal outcome
Time frame: 10 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 20 Jan 2025.
- Arti Kumari1,Anupama Sinha2.(2024)A Feto-Maternal Outcome of Primigravida with Unengaged Head at Term.International Journal of Pharmaceutical and Clinical Research ; 16(7); 998-1002Link provided by the sponsor.
- L., R., Sujatha Prabhu, \& Kusuma Naik M. V. (2023). Maternal and fetal outcome in primigravida with unengaged head at term in labour. International Journal of Reproduction, Contraception, Obstetrics and Gynecology, 12(6), 1569-1574.Link provided by the sponsor.
- Priya Agarwal, Shraddha Shetty. Clinical study of primigravida with unengaged head in labour at term .Int J Women's Health Rerpod Sci 9, 2021Link provided by the sponsor.
- Orji EO, Ndububa VI. Obstetric performance of women aged over forty years. East Afr Med J. 2004;81:139-41. doi: 10.4314/eamj.v81i3.9143. \[DOI\] \[PubMed\] \[Google Scholar\]Link provided by the sponsor.
- Ogedengbe OK, Odeneye TO. Outcome of Instrumental deliveries in Lagos Nigeria. Implications for its use at the second tier healthcare level. Nig Med Pract. 2006;45:106-10. \[Google Scholar\]Link provided by the sponsor.
- .Danish N, Fawad A, Abbasi N. Assessment of pregnancy outcome in primigravida: Comparison between booked and un-booked patients. J Ayub Med Coll Abbottabad. 2010;22:23-5. \[PubMed\] \[Google Scholar\]Link provided by the sponsor.
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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 Primigravida Labour, 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 3 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 20 Jan 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?
Contact Professor Ahmed Abbas (+20 01003385183, bmr90@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal outcome (time frame: 10 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 20 Jan 2025.