Infants of Diabetic Mothers: A Cohort Study

Fetal Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079415
• Other study ID #: OJS2817
• Status: Completed
• Phase: N/A
• First received: February 16, 2014
• Last updated: May 22, 2015
• Start date: January 2011
• Est. completion date: October 2012

Study information

• Verified date: May 2015
• Source: Security Forces Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: October 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fetal Complications
• Pregnancy in Diabetes
• Pregnancy in Diabetics

Intervention

Other:
• Prevention of complications in infants of diabetic mothers
strict glycemic control in diabetic pregnancies

Locations

Country	Name	City	State
Saudi Arabia	Security Forces Hospital	Riyadh	Central

Sponsors (1)

Lead Sponsor	Collaborator
Security Forces Hospital

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Preterm birth	To assess incidence of preterm birth in infants of diabetic mothers	Immediately at day 1	No
Other	Admission to neonatal intensive care unit	To assess the need of infants of diabetic mothers for admission to neonatal intensive care	day 1	No
Primary	Congenital malformations	Assess presence of congenital malformations in infants of diabetic mothers	At time of first clinical examination	No
Secondary	Length of hospital stay	To assess the length of hospital stay for infants of diabetic mothers	Until discharge from hospital or death	No