NCT03666078

Brief Summary

This study will be done at Ain Shams university maternity hospital to identify the significant risk of maternal intensive care unit admission, need for advanced surgery, postpartum hemorrhage, need for blood transfusion, febrile morbidity, neonatal intensive care unit admission (NICU), need for neonatal intubation and low APGAR scoring in both vaginal and cesarean section .and this will lead us to know if cesarean section rates in our unit is a safe alternative to vaginal delivery and which of both maneuvers will introduce fewer hazards to mother and fetus.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

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

Study Start

First participant enrolled

July 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

September 10, 2018

Last Update Submit

January 13, 2019

Conditions

Delivery ,Complications,MaternalDelivery,Complication,Fetal

Outcome Measures

Primary Outcomes (1)

  • labor and delivery outcome

    document maternal and perinatal morbidity

    24 hours

Study Arms (4)

normal vaginal delivery

assisted vaginal delivery

elective cesarean delivery

Procedure: cesarean delivery

emergency cesarean delivery

Procedure: cesarean delivery

Interventions

cesarean deliveryPROCEDURE

women delivered by cesarean section

elective cesarean deliveryemergency cesarean delivery

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

all women who delivered vaginally and by cesarean section at Ain Shams maternity hospital will be included.

You may qualify if:

  • All of the patients who will deliver vaginally
  • All of the patients who will deliver by cesarean sections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams maternity hospital

Cairo, 11566, Egypt

RECRUITING

MeSH Terms

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Tamer F Borg, professor

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed M Samy, MD

CONTACT

01001947488Mohammedsamy8132@gmail.com

Ahmed N Shaker

CONTACT

01098670624dr_nagy.ahmed@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
resident of obstetrics and gynecology

Study Record Dates

First Submitted

September 10, 2018

First Posted

September 11, 2018

Study Start

July 15, 2018

Primary Completion

March 1, 2019

Study Completion

April 1, 2019

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

EG(1)