Gestational Diabetes: the Prevention

Pregnancy Clinical Trial

Official title:

Gestational Diabetes. The Rol of Exercise in the Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790412
• Other study ID #: Technical University of Madrid
• Status: Completed
• Phase: N/A
• First received: February 5, 2013
• Last updated: February 11, 2013
• Start date: February 2009
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: Technical University of Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes, Gestational
• Pregnancy

Intervention

Behavioral:
• Exercise group
Combined two land aerobic sessions and one aquatic activities session

Locations

Country	Name	City	State
Spain	Technical University of Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other pregnancy outcomes	macrosomia, type of delivery, birth weight	After delivery	No
Primary	prevention gestational diabetes	Oral glucose tolerance test (OGTT)	weeks 24-30	No
Secondary	Maternal weight gain	Maternal weight gain above guidelines recommendations by Institute of Medicine and National Research Council (IOM)	weeks 40-42	No