NCT03169205

Brief Summary

The aim of this work is to demonstrate the variation of Diabetes mellitus either preexisting or gestational Diabetes mellitus among pregnant ladies in our localities, detect maternal \& fetal complications and to predict the risk factors for poor maternal, fetal \& neonatal outcomes

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

2 active sites

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

May 1, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

May 24, 2017

Last Update Submit

May 25, 2017

Conditions

Pregnancy in Diabetics

Outcome Measures

Primary Outcomes (1)

  • Maternal outcome

    No. of patients who have preeclampsia,eclampsia,preterm delivery,Cesarean section,vaginal candidiasis,premature rupture of membrane,polyhydramnios,oligohydramnios,accidental hemorrhage,birth canal injuries,puerperal sepsis,wound infection,postpartum glucose intolerance.

    2 years

Secondary Outcomes (1)

  • fetal outcome

    2 years

Study Arms (3)

preexisting Diabetes mellitus type 1

Other: observation registry

preexisting Diabetes mellitus type 2

Other: observation registry

Gestational Diabetes mellitus

Other: observation registry

Interventions

observation registryOTHER

observation registry

Gestational Diabetes mellituspreexisting Diabetes mellitus type 1preexisting Diabetes mellitus type 2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All pregnant ladies with impaired glucose intolerance either known before or fisrt diagnosed during current pregnancy

You may qualify if:

  • all pregnant ladies with Diabetes mellitus either type 1 or type 2
  • all pregnant ladies with glucose intolerance which is first diagnosed during current pregnancy

You may not qualify if:

  • ladies age less than 18 year or above 45

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Medicine

Banī Suwayf, Egypt

Location

Unknown Facility

Banī Suwayf, Egypt

Location

MeSH Terms

Conditions

Pregnancy in Diabetics

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer

Study Record Dates

First Submitted

May 24, 2017

First Posted

May 30, 2017

Study Start

May 1, 2017

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

EG(2)