Effect of Caffeine on Fetal Growth

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

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131690

Danish Epidemiology Science Centre
Vennelyst Boulevard 6, Aarhus, Denmark, 8000
Sponsors and Collaborators
The Danish Epdiemiology Science Centre
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:
Birth weight

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 04, 2016