NCT00367549

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2006

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 6, 2011

Status Verified

May 1, 2010

Enrollment Period

2.1 years

First QC Date

August 22, 2006

Last Update Submit

July 3, 2011

Conditions

Labor, Obstetric

Keywords

Laborinstrumental deliverynutritionepidural anesthesiaoxytocin

Outcome Measures

Primary Outcomes (1)

  • The course of the labor by women (parity 0) at gestational age > 36 weeks, including: total labor time

    At time of birth

Secondary Outcomes (4)

  • Length of stage 1 (cervical opening < 10 cm) and stage 2 (pushing time)

  • Use of epidural anesthetics

  • Use of contraction-stimulating drugs

  • Instrumental delivery

Interventions

Energy-containing soft drinkDIETARY_SUPPLEMENT

Commercial energy/sports drink

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women at gestational age \> 36 weeks, parity 0

You may not qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kristin Kardel

Oslo, 0027, Norway

Location

Study Officials

  • Tore Henriksen, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2006

First Posted

August 23, 2006

Study Start

September 1, 2006

Primary Completion

October 1, 2008

Study Completion

December 1, 2009

Last Updated

July 6, 2011

Record last verified: 2010-05

Locations

NO(1)