NCT03451864

Brief Summary

Eighty-eight pregnant women and their newborns were enrolled in a cross-sectional study. Maternal serum 25-OHD was measured by ELISA

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 25, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
Last Updated

March 2, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

February 25, 2018

Last Update Submit

February 25, 2018

Conditions

Neonatal Outcome

Outcome Measures

Primary Outcomes (1)

  • Neonatal intensive care unit admission

    Admission of the neonate to NICU

    24 hours after delivery

Study Arms (2)

Deficient Vit D

Mothers with serum 25(OH) D levels less than 20 ng/dl

Procedure: Vaginal deliveryProcedure: Cesarean Section

Normal vit D

Mothers with serum 25(OH) D levels more than 20 ng/dl

Procedure: Vaginal deliveryProcedure: Cesarean Section

Interventions

Vaginal deliveryPROCEDURE

classic vaginal delivery

Deficient Vit DNormal vit D
Cesarean SectionPROCEDURE

routine lower segment cesarean scetion

Deficient Vit DNormal vit D

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

88 full term neonates of both sexes born to 88 healthy women with a mean age was 27.0 ± 5.0 years. Forty-one (46.6%) had normal vaginal delivery and 47 (53.4%) underwent cesarean section

You may qualify if:

  • Healthy women Term pregnancy

You may not qualify if:

  • any chronic illness as chronic hypertension or pregestational diabetes pregnancy-related illnesses as preeclampsia, gestational diabetes multiple pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

MeSH Terms

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ahmed Maged, MD

    professor

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 25, 2018

First Posted

March 2, 2018

Study Start

September 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 24, 2018

Last Updated

March 2, 2018

Record last verified: 2018-02

Locations

EG(1)