Nutrition as a Determinant of Labor Outcome

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

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-12-31

Brief Summary

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

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Detailed Description

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

Conditions

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Labor, Obstetric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Energy-containing soft drink

Commercial energy/sports drink

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes