Nutrition as a Determinant of Labor Outcome | NCT00367549

Studies
Nutrition as a Determinant of Labor Outcome

NCT00367549

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Jul 6, 2011Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Labor, Obstetric

Interventions

Energy-containing soft drink

Countries

Norway

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

May 2010

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

Sep 2006

Primary Completion Date

Oct 2008Actual

Completion Date

Dec 2009Actual

First Submitted Date

Aug 22, 2006

First Submission Date that Met QC Criteria

Aug 22, 2006

First Posted Date

Aug 23, 2006Estimated

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

Jul 3, 2011

Last Update Posted Date

Jul 6, 2011Estimated

Name	Class
University of Oslo	OTHER

Description Module

Brief Summary

This is a randomized, double-blind trial looking at how nutrition intake is associated with labor progress and complications.

Detailed Description

Insufficient intake of energy during labor may result in poor labor progress. The study investigates the effect of an energy supplement during labor.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Name	Type	Description	Arm Group Labels	Other Names
Energy-containing soft drink	Dietary Supplement	Commercial energy/sports drink

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The course of the labor by women (parity 0) at gestational age > 36 weeks, including: total labor time		At time of birth

Secondary Outcomes

Measure	Description	Time Frame
Length of stage 1 (cervical opening < 10 cm) and stage 2 (pushing time)
Use of epidural anesthetics
Use of contraction-stimulating drugs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women at gestational age > 36 weeks, parity 0

Exclusion Criteria:

Gestational age < 36 weeks
Signs of fetal pathology:
- Different or abnormal (pathological) CTG test performed just before start of the test
- Abnormal Doppler registrations (PI in the arteria umbilicae > 2SD for the gestational age)
- Established notch in the arteria uterinae or notch bilaterally or PI > 2SD > 24 weeks
- Diverging in the weight of the fetus > - 22% or diverging in the growth of the fetus - 10% or more, and established structural pathology in the fetus, oligohydramnion (amniotic fluid index < 6)
Maternal diseases and pregnancy complications
- diabetes in pregnancy
- high blood pressure
- cardiovascular diseases
- rheumatic disease
- epilepsia
- lung disease, etc.

CTG test: cardiotocographic test (a measure of fetal activity)

PI: pulsatory index (velocity pattern)

SD: standard deviation

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided