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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03169205
Other study ID # 2500
Secondary ID
Status Enrolling by invitation
Phase N/A
First received May 24, 2017
Last updated May 25, 2017
Start date May 1, 2017
Est. completion date May 1, 2019

Study information

Verified date May 2017
Source Beni-Suef University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date May 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- ladies age less than 18 year or above 45

Study Design


Related Conditions & MeSH terms


Intervention

Other:
observation registry
observation registry

Locations

Country Name City State
Egypt Faculty of Medicine Beni-suef

Sponsors (1)

Lead Sponsor Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 fetal outcome No. of abortion,prematurity,macrosomia,congenital anomalies,intrauterine fetal death,still birth,shoulder dystocia,brachial plexus injury,neonatal death,respiratory distress syndrome,neonatal jaundice requiring photo-therapy,neonatal hypoglycemia, 2 years
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