Infants of Diabetic Mothers: A Cohort Study

May 22, 2015 updated by: OMER B ABDELBASIT, Security Forces Hospital

Study of Outcome of Infants of Diabetic Mothers in a Tertiary Hospital Set up

Saudi Arabia has been named by the International Diabetes Federation as among the top ten countries with highest prevalence of diabetes. Women are said to have overall prevalence twice that for men. With high birth rate in the country we decided to look at the impact of diabetic pregnancies on their off-springs

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetics are followed regularly in diabetic outpatient clinics where dietary and medical management are offered. Diabetic pregnancies are managed by a team consisting of diabetologist, obstetrician, feto-maternal obstetrician and dietician.

Management of these pregnancies depends on whether these women have pre-gestational or gestational diabetes. Very few diabetic women have exposure to preconceptual advice. For this reason we opted to find out the outcome of infants of diabetic mothers compared to those mothers who are essentially normal with no associated medical or obstetric disorders. Equally we wanted to see if there are differences in the outcome of infants born to pre-gestational and gestational diabetic mothers.

Study Type

Observational

Enrollment (Actual)

601

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

  • Saudi Arabia
    • Central
      • Riyadh, Central, Saudi Arabia, 11481
        • Security Forces Hospital

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

1 hour and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All Infants of diabetic mothers born at security Forces Hospital, Riyadh

Description

Inclusion Criteria:All infants born to diabetic mothers

  • Infants born to mothers with normal pregnancies

Exclusion Criteria:

  • Infants born to mothers with other medical disorders before or during pregnancy which may affect the newborn

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Congenital malformations
Time Frame: At time of first clinical examination
Assess presence of congenital malformations in infants of diabetic mothers
At time of first clinical examination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Until discharge from hospital or death
To assess the length of hospital stay for infants of diabetic mothers
Until discharge from hospital or death

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preterm birth
Time Frame: Immediately at day 1
To assess incidence of preterm birth in infants of diabetic mothers
Immediately at day 1
Admission to neonatal intensive care unit
Time Frame: day 1
To assess the need of infants of diabetic mothers for admission to neonatal intensive care
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Security Forces Hospital

Investigators

  • Study Director: ABEER E LASHEEN, MBBS, Security Forces Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

February 16, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimate)

March 5, 2014

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 22, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OJS2817

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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