NCT03905980

Brief Summary

women in their first pregnancy evaluated till delivery for associated risk factors for cesarean delivery

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

April 30, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

April 4, 2019

Last Update Submit

July 24, 2019

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (1)

  • route of delivery in primigravida

    at delivery

Study Arms (2)

Vaginal delivery

woman who terminate their pregnancy by vaginal delivery

Procedure: vaginal delivery

Cesarean delivery

woman who terminate their pregnancy by cesarean delivery

Procedure: Cesarean section

Interventions

vaginal deliveryPROCEDURE

pregnancy ended by vaginal delivery

Vaginal delivery
Cesarean sectionPROCEDURE

pregnancy ended by cesarean delivery

Cesarean delivery

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

woman carrying their first pregnancy

You may qualify if:

  • women in their first pregnancy
  • Delivery between 37 and 42 weeks
  • Singleton pregnancy \_ cephalic presentation

You may not qualify if:

  • women asked for CS on demand

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

RECRUITING

MeSH Terms

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ahmed Maged, MD

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

+201005227404prof.ahmedmaged@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 8, 2019

Study Start

April 30, 2019

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

July 26, 2019

Record last verified: 2019-07

Locations

EG(1)