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Infants of Diabetic Mothers: A Cohort Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02079415
Enrollment
601
Registered
2014-03-05
Start date
2011-01-31
Completion date
2012-10-31
Last updated
2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Complications, Pregnancy in Diabetes

Keywords

NICU

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.

Interventions

OTHERPrevention of complications in infants of diabetic mothers

strict glycemic control in diabetic pregnancies

Sponsors

Security Forces Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Hours to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Congenital malformationsAt time of first clinical examinationAssess presence of congenital malformations in infants of diabetic mothers

Secondary

MeasureTime frameDescription
Length of hospital stayUntil discharge from hospital or deathTo assess the length of hospital stay for infants of diabetic mothers

Other

MeasureTime frameDescription
Preterm birthImmediately at day 1To assess incidence of preterm birth in infants of diabetic mothers
Admission to neonatal intensive care unitday 1To assess the need of infants of diabetic mothers for admission to neonatal intensive care

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026