Effect of Caffeine on Fetal Growth

NCT ID: NCT00131690

Last Updated: 2005-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-04-30

Study Completion Date

2002-08-31

Brief Summary

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

Detailed Description

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Conditions

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Birth Weight

Keywords

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Caffeine Coffee Randomized Birth weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Nescafé Gold Blend (exposed)

Intervention Type DRUG

Nescafé Decaffeinated (controls)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Danish Epdiemiology Science Centre

OTHER

Sponsor Role lead

Principal Investigators

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Jørn Olsen, Professor

Role: STUDY_CHAIR

Danish Epidemiology Science Centre

Locations

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Danish Epidemiology Science Centre

Vennelyst Boulevard 6, Aarhus, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 17259189 (View on PubMed)

Other Identifiers

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1994/2974

Identifier Type: -

Identifier Source: org_study_id