Gestational Diabetes: the Prevention | NCT01790412

Studies
Gestational Diabetes: the Prevention

NCT01790412

Sponsor

Technical University of Madrid

Status

Completed

Last Update Posted

Feb 13, 2013Estimated

Enrollment

257Actual

Phase

Not Applicable

Conditions

Pregnancy

Interventions

Exercise group

Countries

Spain

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

Feb 2013

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

Feb 2009

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Feb 5, 2013

First Submission Date that Met QC Criteria

Feb 11, 2013

First Posted Date

Feb 13, 2013Estimated

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

Feb 11, 2013

Last Update Posted Date

Feb 13, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yaiza Cordero Rodríguez, Gestational Diabetes. The Role of Exercise in the Prevention, Technical University of MadridPrincipal Investigator

Lead Sponsor

Technical University of MadridOTHER

Collaborators

Not provided

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

To assess the effectiveness of an exercise program developed during pregnancy (land/aquatic activities) aerobic and muscular tonification, on control to the prevention to Gestational Diabetes. And to assess if excessive maternal weight gain is an influence in the diagnostic.

Detailed Description

A clinical, randomized controlled trial was used. 342 pregnant women without obstetric contraindications accepted informed consent for inclusion in the study. Finally, 257 were studied, 101 in intervention group (IG, n= 101) and 156 in control group (GC, n= 156). A physical exercise program three times per week during pregnancy was developed. The duration of session was 60 minutes and 50 minutes in land and water, respectively.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

257Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise group	Experimental	Three sessions per week: Supervised exercise program	Behavioral: Exercise group
Control	No Intervention	Sedentary pregnant women

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise group	Behavioral	Combined two land aerobic sessions and one aquatic activities session	Exercise group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prevention gestational diabetes	Oral glucose tolerance test (OGTT)	weeks 24-30

Secondary Outcomes

Measure	Description	Time Frame
Maternal weight gain	Maternal weight gain above guidelines recommendations by Institute of Medicine and National Research Council (IOM)	weeks 40-42

Other Outcomes

Measure	Description	Time Frame
Other pregnancy outcomes	macrosomia, type of delivery, birth weight	After delivery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy pregnant women
At week 8-14
Adherence 80% (minimum) until the end of pregnancy

Exclusion Criteria:

Contraindications appointed by American College of Obstetricians & Gynecologists (ACOG)
No adherence

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rubén Barakat, PhD	Technical University of Madrid	Study Director
Yaiza Cordero, PhD Student	Technical University of Madrid	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Technical University of Madrid		Madrid	Madrid	28040	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25333246	Derived	Cordero Y, Mottola MF, Vargas J, Blanco M, Barakat R. Exercise Is Associated with a Reduction in Gestational Diabetes Mellitus. Med Sci Sports Exerc. 2015 Jul;47(7):1328-33. doi: 10.1249/MSS.0000000000000547.

ID	Term
D009043	Motor Activity
D016640	Diabetes, Gestational

ID	Term
D001519	Behavior
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases