NCT Number: NCT06784505
Obstetric Outcomes of Primigravidae
To determine obstetric outcomes in primigravida at term at women's health centre
Trial opening soon.
Get NotifiedKey information
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Primigravida with singleton live fetus
- Cephalic presentation
- Delivered at term with gestational age(37 -41 weeks)
Exclusion criteria
- Multiparous women
- Multiple gestation
- Intra Uterine fetal death th (IUFD)
- Medical condition as preclampsia
- Polyhydramnios and fetal anomalies
- Malpresentation (e.g., breech, face).
Treatment and study plan
Primary outcomes
-
Maternal outcome
Time frame: 10 hours
Maternal outcome woth respect to course of labour & duration of first and second stage of labour
Secondary outcomes
-
Progress of labour & neonatal outcome
Time frame: 10 hours
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
Study contacts
Contact information is provided by the study sponsor or research team.
Menna Abdelaziz Ahmed, Resident
CONTACT
Professor Ahmed Abbas
CONTACT
Sponsors and collaborators
Lead sponsor
Assiut University
Other
Registry information
Official study title
Obstetric Outcomes of Primigravidae At Women's Health Centre; Cross Sectional Study
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jan 20, 2025
- Registry last updated
- Jan 20, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.