Nutrition as a Determinant of Labor Outcome

University of Oslo (UIO)

Status: Completed

Conditions: Labor, Obstetric

Treatments: Dietary Supplement: Energy-containing soft drink

Study type: Interventional

Funder types: Other

Identifiers

NCT00367549

REK-SØR: S-05308

Details and patient eligibility

About

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

Full description

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

Enrollment: 200 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind