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Effect of Caffeine on Fetal Growth

This study has been completed.
Sponsor:
Information provided by:
The Danish Epdiemiology Science Centre
ClinicalTrials.gov Identifier:
NCT00131690
First received: August 17, 2005
Last updated: October 7, 2005
Last verified: August 2005
History of Changes
  Purpose

The purpose of this study is to determine whether caffeine has any effect on birth weight.


Condition Intervention Phase
Birth Weight
 Drug: Nescafé Gold Blend (exposed)
Drug: Nescafé Decaffeinated (controls)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: The Importance of Caffeine in Fetal Growth

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Danish Epdiemiology Science Centre:

Primary Outcome Measures:
  • birth weight
  • gestational age

Estimated Enrollment: 1200
Study Start Date: April 1996
Estimated Study Completion Date: August 2002
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant
  • Consumption of at least 3 cups of coffee/day at recruitment

Exclusion Criteria:

  • Gestational age more than 20 weeks at recruitment
  • Chronic kidney disease
  • Epilepsy
  • Insulin dependent diabetes
  • Metabolic disorder
  • Previous low birth weight delivery
  • Previous preterm delivery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131690

Locations
Denmark
Danish Epidemiology Science Centre
Vennelyst Boulevard 6, Aarhus, Denmark, 8000
Sponsors and Collaborators
The Danish Epdiemiology Science Centre
Investigators
Study Chair: Jørn Olsen, Professor Danish Epidemiology Science Centre
  More Information

No publications provided by The Danish Epdiemiology Science Centre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00131690     History of Changes
Other Study ID Numbers: 1994/2974
Study First Received: August 17, 2005
Last Updated: October 7, 2005
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by The Danish Epdiemiology Science Centre:
Caffeine
Coffee
Randomized
Birth weight

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 16, 2013