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Completed

NCT Number: NCT02079415

Infants of Diabetic Mothers: A Cohort Study

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

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Key information

Conditions

Pregnancy in Diabetes Female Urogenital Diseases and Pregnancy Complications Fetal Complications Pregnancy Complications Pregnancy in Diabetics Urogenital Diseases

Age range

1 hour and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Security Forces Hospital

Riyadh, Central, 11481, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevention of complications in infants of diabetic mothers

Other

strict glycemic control in diabetic pregnancies

Other names: Congenital malformations

Primary outcomes

  1. Congenital malformations

    Time frame: At time of first clinical examination

    Assess presence of congenital malformations in infants of diabetic mothers

Secondary outcomes

  1. Length of hospital stay

    Time frame: Until discharge from hospital or death

    To assess the length of hospital stay for infants of diabetic mothers

Other outcomes

  1. Preterm birth

    Time frame: Immediately at day 1

    To assess incidence of preterm birth in infants of diabetic mothers

  2. 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

Sponsors and collaborators

Lead sponsor

Security Forces Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 5, 2014
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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