search
Back to results

Effect of Caffeine on Fetal Growth

Primary Purpose

Birth Weight

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Nescafé Gold Blend (exposed)
Nescafé Decaffeinated (controls)
Sponsored by
The Danish Epdiemiology Science Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Birth Weight focused on measuring Caffeine, Coffee, Randomized, Birth weight

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Danish Epidemiology Science Centre

Outcomes

Primary Outcome Measures

birth weight
gestational age

Secondary Outcome Measures

Full Information

First Posted
August 17, 2005
Last Updated
October 7, 2005
Sponsor
The Danish Epdiemiology Science Centre
search

1. Study Identification

Unique Protocol Identification Number
NCT00131690
Brief Title
Effect of Caffeine on Fetal Growth
Official Title
The Importance of Caffeine in Fetal Growth
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
April 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Danish Epdiemiology Science Centre

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birth Weight
Keywords
Caffeine, Coffee, Randomized, Birth weight

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nescafé Gold Blend (exposed)
Intervention Type
Drug
Intervention Name(s)
Nescafé Decaffeinated (controls)
Primary Outcome Measure Information:
Title
birth weight
Title
gestational age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jørn Olsen, Professor
Organizational Affiliation
Danish Epidemiology Science Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Danish Epidemiology Science Centre
City
Vennelyst Boulevard 6
State/Province
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
17259189
Citation
Bech BH, Obel C, Henriksen TB, Olsen J. Effect of reducing caffeine intake on birth weight and length of gestation: randomised controlled trial. BMJ. 2007 Feb 24;334(7590):409. doi: 10.1136/bmj.39062.520648.BE. Epub 2007 Jan 26.
Results Reference
derived

Learn more about this trial

Effect of Caffeine on Fetal Growth

We'll reach out to this number within 24 hrs