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Completed

NCT Number: NCT00367549

Nutrition as a Determinant of Labor Outcome

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

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Key information

Conditions

Labor, Obstetric

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kristin Kardel

Oslo, 0027, Norway

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Energy-containing soft drink

Dietary Supplement

Commercial energy/sports drink

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University of Oslo

Registry information

Official study title

Nutrition as Determinant of Labor Outcome

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Aug 23, 2006
Registry last updated
Jul 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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