Infants of Diabetic Mothers: A Cohort Study

NCT ID: NCT02079415

Last Updated: 2015-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

601 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Pregnancy in Diabetes Fetal Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Prevention of complications in infants of diabetic mothers

strict glycemic control in diabetic pregnancies

Intervention Type OTHER

Other Intervention Names

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Congenital malformations

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

1 Hour

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Security Forces Hospital

OTHER

Sponsor Role lead

Responsible Party

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OMER B ABDELBASIT

Consultant Neonatolgist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ABEER E LASHEEN, MBBS

Role: STUDY_DIRECTOR

Security Forces Hospital

Locations

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Security Forces Hospital

Riyadh, Central, Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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Alqurashi KA, Aljabri KS, Bokhari SA. Prevalence of diabetes mellitus in a Saudi community. Ann Saudi Med. 2011 Jan-Feb;31(1):19-23. doi: 10.4103/0256-4947.75773.

Reference Type BACKGROUND
PMID: 21245594 (View on PubMed)

Persson M, Norman M, Hanson U. Obstetric and perinatal outcomes in type 1 diabetic pregnancies: A large, population-based study. Diabetes Care. 2009 Nov;32(11):2005-9. doi: 10.2337/dc09-0656. Epub 2009 Aug 12.

Reference Type BACKGROUND
PMID: 19675195 (View on PubMed)

Yang J, Cummings EA, O'connell C, Jangaard K. Fetal and neonatal outcomes of diabetic pregnancies. Obstet Gynecol. 2006 Sep;108(3 Pt 1):644-50. doi: 10.1097/01.AOG.0000231688.08263.47.

Reference Type RESULT
PMID: 16946226 (View on PubMed)

Other Identifiers

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OJS2817

Identifier Type: -

Identifier Source: org_study_id

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