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Completed

NCT Number: NCT01790412

Gestational Diabetes: the Prevention

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.

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Key information

Conditions

Pregnancy Behavior Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Technical University of Madrid

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise group

Behavioral

Combined two land aerobic sessions and one aquatic activities session

Primary outcomes

  1. prevention gestational diabetes

    Time frame: weeks 24-30

    Oral glucose tolerance test (OGTT)

Secondary outcomes

  1. Maternal weight gain

    Time frame: weeks 40-42

    Maternal weight gain above guidelines recommendations by Institute of Medicine and National Research Council (IOM)

Other outcomes

  1. Other pregnancy outcomes

    Time frame: After delivery

    macrosomia, type of delivery, birth weight

Sponsors and collaborators

Lead sponsor

Technical University of Madrid

Other

Registry information

Official study title

Gestational Diabetes. The Rol of Exercise in the Prevention

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 13, 2013
Registry last updated
Feb 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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