Engagement of Fetal Head as a Predictor of a Successful Vaginal Delivery in Primigravidas Presented in Early Labor.
1 other identifier
observational
226
1 country
1
Brief Summary
In primigravida, Delayed engagement of fetal head has been theorized that it is more likely in women with a possible cephalo-pelvic disproportion, so far they are associated with higher risk of cervical dystocia, which led to increased rate of caesarean section.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
Started Nov 2020
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 3, 2020
CompletedFirst Submitted
Initial submission to the registry
October 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 3, 2021
CompletedFirst Posted
Study publicly available on registry
October 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2021
CompletedJanuary 21, 2022
January 1, 2022
11 months
October 3, 2021
January 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of cesarean section in primigravidas with unengaged fetal head in compare to primigavidas with engaged fetal head .
section in primigravidas with unengaged fetal head in compare to primigavidas with engaged fetal head .
24 hours
Secondary Outcomes (1)
Duration of labor progress in patients with unengaged
24 Hours
Study Arms (1)
Mohamedabosena
Interventions
In addition to the fetal lie, presentation, and position, the level or station of the presenting part in the maternal pelvis is an important factors in the labor process. In primigravida, Delayed engagement of fetal head has been theorized that it is more likely in women with a possible cephalo-pelvic disproportion, so far they are associated with higher risk of cervical dystocia, which led to increased rate of caesarean section.
Eligibility Criteria
primigravidas, full term in early labor, Ain shams maternity hospital.
You may qualify if:
- Term pregnancy (37-42) weeks.
- Expected foetal birth weight of 2.5-4.0 kg on USG at term.
- Singleton live pregnancy.
- Cephalic presentation.
- Cervical dilatation of =/\< 4cms.
- Reactive CTG at onset of labour.
- Confirmation of ROM by Direct visualization or Fern test.
You may not qualify if:
- Contracted pelvis.
- Previous uterine surgery " upper segment ".
- Pregnancy complications like antepartum haemorrhage, pregnancy induced hypertension, gestational diabetes mellitus, IUGR.
- Fetal congenital anomalies.
- Abnormal or non reassuring fetal CTG at term or at onset of labour.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- mohamed abosenalead
- Ain Shams Universitycollaborator
Study Sites (1)
Ain Shams university
Cairo, 11511, Egypt
Study Officials
- STUDY DIRECTOR
Mohamed M sami, Consultant
As.Professor
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 3, 2021
First Posted
October 19, 2021
Study Start
November 3, 2020
Primary Completion
October 3, 2021
Study Completion
November 20, 2021
Last Updated
January 21, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share