Effect of Caffeine on Fetal Growth | NCT00131690

Studies
Effect of Caffeine on Fetal Growth

NCT00131690

Sponsor

The Danish Epdiemiology Science Centre

Status

Completed

Last Update Posted

Oct 10, 2005Estimated

Enrollment

1,200

Phase

Phase 4

Conditions

Birth Weight

Interventions

Nescafé Gold Blend (exposed)
Nescafé Decaffeinated (controls)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1996

Primary Completion Date

Not provided

Completion Date

Aug 2002

First Submitted Date

Aug 17, 2005

First Submission Date that Met QC Criteria

Aug 17, 2005

First Posted Date

Aug 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2005

Last Update Posted Date

Oct 10, 2005Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jørn Olsen, Professor	Danish Epidemiology Science Centre	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danish Epidemiology Science Centre		Vennelyst Boulevard 6	Aarhus	8000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17259189	Derived	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.

ID	Term
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Name	Type	Description	Arm Group Labels	Other Names
Nescafé Gold Blend (exposed)	Drug
Nescafé Decaffeinated (controls)	Drug

Measure	Description	Time Frame
birth weight
gestational age