NCT05084326

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2021

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

October 3, 2021

Last Update Submit

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

Procedure: Engagement of fetal head as a predictor of a successful vaginal delivery

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.

Mohamedabosena

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Study Sites (1)

Ain Shams university

Cairo, 11511, Egypt

Location

Study Officials

  • Mohamed M sami, Consultant

    As.Professor

    STUDY DIRECTOR

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

Locations