Infants of Diabetic Mothers: A Cohort Study

Completed

• Conditions: Fetal Complications; Pregnancy in Diabetes

• Registration Number: NCT02079415
• Lead Sponsor: Security Forces Hospital

Brief Summary

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

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 Timeline

• Study Start: 2011-01
• Primary Completion: 2012-01
• Study Completion: 2012-10
• Study First Submitted: 2014-02-16
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-05
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-22
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 601

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Congenital malformations	At time of first clinical examination	Assess presence of congenital malformations in infants of diabetic mothers

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	Until discharge from hospital or death	To assess the length of hospital stay for infants of diabetic mothers

Trial Locations

Locations (1)

Security Forces Hospital; 🇸🇦 Riyadh, Central, Saudi Arabia