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Nutrition as a Determinant of Labor Outcome

This study has been completed.
Sponsor:
Collaborator:
University of Oslo
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00367549
First received: August 22, 2006
Last updated: July 3, 2011
Last verified: May 2010
  Purpose
This is a randomized, double-blind trial looking at how nutrition intake is associated with labor progress and complications.

Condition Intervention
Labor, Obstetric Dietary Supplement: Energy-containing soft drink

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nutrition as Determinant of Labor Outcome

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • The course of the labor by women (parity 0) at gestational age > 36 weeks, including: total labor time [ Time Frame: At time of birth ]

Secondary Outcome Measures:
  • Length of stage 1 (cervical opening < 10 cm) and stage 2 (pushing time)
  • Use of epidural anesthetics
  • Use of contraction-stimulating drugs
  • Instrumental delivery

Estimated Enrollment: 200
Study Start Date: September 2006
Study Completion Date: December 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Energy-containing soft drink
    Commercial energy/sports drink
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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367549

Locations
Norway
Kristin Kardel
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Investigators
Principal Investigator: Tore Henriksen, MD Oslo University Hospital
  More Information

Responsible Party: Kristin Kardel, Stip., Rikshospitalet University Hospital
ClinicalTrials.gov Identifier: NCT00367549     History of Changes
Other Study ID Numbers: REK-SØR: S-05308
Study First Received: August 22, 2006
Last Updated: July 3, 2011

Keywords provided by Oslo University Hospital:
Labor
instrumental delivery
nutrition
epidural anesthesia
oxytocin

ClinicalTrials.gov processed this record on September 21, 2017