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Effect of Caffeine on Fetal Growth

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ClinicalTrials.gov Identifier: NCT00131690
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : October 10, 2005
Sponsor:
Information provided by:
The Danish Epdiemiology Science Centre

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

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: The Importance of Caffeine in Fetal Growth
Study Start Date : April 1996
Study Completion Date : August 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. birth weight
  2. gestational age


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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: October 10, 2005
Last Verified: August 2005

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
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents