Effect of Caffeine on Fetal Growth

October 7, 2005 updated by: The Danish Epdiemiology Science Centre

The Importance of Caffeine in Fetal Growth

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Aarhus
      • Vennelyst Boulevard 6, Aarhus, Denmark, 8000
        • Danish Epidemiology Science Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
birth weight
gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Danish Epdiemiology Science Centre

Investigators

  • Study Chair: Jørn Olsen, Professor, Danish Epidemiology Science Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1996

Study Completion

August 1, 2002

Study Registration Dates

First Submitted

August 17, 2005

First Submitted That Met QC Criteria

August 17, 2005

First Posted (Estimate)

August 19, 2005

Study Record Updates

Last Update Posted (Estimate)

October 10, 2005

Last Update Submitted That Met QC Criteria

October 7, 2005

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1994/2974

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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