Nutrition as Determinant of Labor Outcome

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

Description

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

Status: Completed (N/A). Started on September 1st, 2006.

Enrollment: 200 subjects

Study Type: Interventional

Study Design:

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject
Caregiver
Investigator
Outcomes Assessor)
Primary Purpose: Prevention

Conditions:

Labor, Obstetric

Interventions:

Dietary Supplement: Energy-containing soft drink

Eligibility

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

Gender: Female
Mininum Age: N/A
Maximum Age: N/A
Healthy Volunteers: Accepts Healthy Volunteers

Resources

Source: Oslo University Hospital

Authority: Norway: Directorate for Health and Social Affairs

Locations

Kristin Kardel
Oslo
0027
Norway

Officials

Tore Henriksen, MD (Principal Investigator, Oslo University Hospital)

References

None.

Links

None.

Date Verified: May 1st, 2010
First Received: May 26th, 2010
Last Changed: May 26th, 2010

Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.

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