- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03169205
Diabetes Mellitus With Pregnancy in Benisuef Localities
May 25, 2017 updated by: Momen Zakaria Mohammed mohammed, Beni-Suef University
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beni-suef, Egypt
- Faculty of medicine
-
Beni-suef, Egypt
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
All pregnant ladies with impaired glucose intolerance either known before or fisrt diagnosed during current pregnancy
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
preexisting Diabetes mellitus type 1
|
observation registry
|
preexisting Diabetes mellitus type 2
|
observation registry
|
Gestational Diabetes mellitus
|
observation registry
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal outcome
Time Frame: 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fetal outcome
Time Frame: 2 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Anticipated)
May 1, 2019
Study Completion (Anticipated)
May 1, 2019
Study Registration Dates
First Submitted
May 24, 2017
First Submitted That Met QC Criteria
May 25, 2017
First Posted (Actual)
May 30, 2017
Study Record Updates
Last Update Posted (Actual)
May 30, 2017
Last Update Submitted That Met QC Criteria
May 25, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2500
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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