Infants of Diabetic Mothers: A Cohort Study

NCT02079415 | Completed DMC

• 1 other identifier: OJS2817
• Study Type: observational
• Target: 601
• Locations: 1 country
• Sites: 1

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

Conditions

Pregnancy in Diabetes; Fetal Complications

Keywords

NICU

Outcome Measures

Primary Outcomes (1)

• Congenital malformations

  Assess presence of congenital malformations in infants of diabetic mothers

  At time of first clinical examination

Secondary Outcomes (1)

• Length of hospital stay

  Until discharge from hospital or death

Other Outcomes (2)

• Preterm birth

  Immediately at day 1

• Admission to neonatal intensive care unit

  day 1

Interventions

Prevention of complications in infants of diabetic mothers OTHER

strict glycemic control in diabetic pregnancies

Also known as: Congenital malformations

Eligibility Criteria

• Age: 1 Hour+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All Infants of diabetic mothers born at security Forces Hospital, Riyadh

You may qualify if:

• Infants born to mothers with normal pregnancies

You may not qualify if:

• Infants born to mothers with other medical disorders before or during pregnancy which may affect the newborn

Sponsors & Collaborators

• Security Forces Hospital: lead

Study Sites (1)

Security Forces Hospital

Riyadh, Central, 11481, Saudi Arabia

Location

Related 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.

  PMID: 21245594 BACKGROUND

• 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.

  PMID: 19675195 BACKGROUND

• 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.

  PMID: 16946226 RESULT

MeSH Terms

Conditions

Pregnancy in Diabetics

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• ABEER E LASHEEN, MBBS

  Security Forces Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neonatolgist

Study Record Dates

• First Submitted: February 16, 2014
• First Posted: March 5, 2014
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

SA (1)