Obstetric Outcomes of Primigravidae

January 14, 2025 updated by: Menna Allah Abd Elaziaz Ahmed, Assiut University

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

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Primigravida in labor satisfying the inclusion criteria

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal outcome
Time Frame: 10 hours
Maternal outcome woth respect to course of labour & duration of first and second stage of labour
10 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Outcomes in primigravidae

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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