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Nutrition as a Determinant of Labor Outcome

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ClinicalTrials.gov Identifier: NCT00367549
Recruitment Status : Completed
First Posted : August 23, 2006
Last Update Posted : July 6, 2011
Sponsor:
Collaborator:
University of Oslo
Information provided by:
Oslo University Hospital

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

Condition or disease Intervention/treatment Phase
Labor, Obstetric Dietary Supplement: Energy-containing soft drink Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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
Study Start Date : September 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : December 2009

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


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


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Ages Eligible for Study:   Child, Adult, Older Adult
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kristin Kardel, Stip., Rikshospitalet University Hospital
ClinicalTrials.gov Identifier: NCT00367549     History of Changes
Other Study ID Numbers: REK-SØR: S-05308
First Posted: August 23, 2006    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: May 2010

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