Nutrition as a Determinant of Labor Outcome

Labor, Obstetric Clinical Trial

Official title:

Nutrition as Determinant of Labor Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367549
• Other study ID #: REK-SØR: S-05308
• Status: Completed
• Phase: N/A
• First received: August 22, 2006
• Last updated: July 3, 2011
• Start date: September 2006
• Est. completion date: December 2009

Study information

• Verified date: May 2010
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Data Protection AuthorityNorway: Directorate of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

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

Study Design

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

Related Conditions & MeSH terms

• Labor, Obstetric

Intervention

Dietary Supplement:
• Energy-containing soft drink
Commercial energy/sports drink

Locations

Country	Name	City	State
Norway	Kristin Kardel	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The course of the labor by women (parity 0) at gestational age > 36 weeks, including: total labor time		At time of birth
Secondary	Length of stage 1 (cervical opening < 10 cm) and stage 2 (pushing time)
Secondary	Use of epidural anesthetics
Secondary	Use of contraction-stimulating drugs
Secondary	Instrumental delivery