Infants of Diabetic Mothers: A Cohort Study | NCT02079415

Studies
Infants of Diabetic Mothers: A Cohort Study

NCT02079415

Sponsor

Security Forces Hospital

Status

Completed

Last Update Posted

May 27, 2015Estimated

Enrollment

601Actual

Phase

Not provided

Conditions

Pregnancy in Diabetes
Fetal Complications

Interventions

Prevention of complications in infants of diabetic mothers

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Feb 16, 2014

First Submission Date that Met QC Criteria

Mar 4, 2014

First Posted Date

Mar 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2015

Last Update Posted Date

May 27, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

601Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prevention of complications in infants of diabetic mothers	Other	strict glycemic control in diabetic pregnancies		Congenital malformations

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Congenital malformations	Assess presence of congenital malformations in infants of diabetic mothers	At time of first clinical examination

Secondary Outcomes

Measure	Description	Time Frame
Length of hospital stay	To assess the length of hospital stay for infants of diabetic mothers	Until discharge from hospital or death

Other Outcomes

Measure	Description	Time Frame
Preterm birth	To assess incidence of preterm birth in infants of diabetic mothers	Immediately at day 1
Admission to neonatal intensive care unit	To assess the need of infants of diabetic mothers for admission to neonatal intensive care

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Hour

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ABEER E LASHEEN, MBBS	Security Forces Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Security Forces Hospital		Riyadh	Central	11481	Saudi Arabia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21245594	Background	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.
19675195	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.

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases