Energy-containing soft drink in Labor, Obstetric - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Labor, Obstetric

Intervention / Treatment

Dietary supplement: Energy-containing soft 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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Norway
- - Oslo, Norway, 0027
    - Kristin Kardel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Oslo

Investigators

Principal Investigator: Tore Henriksen, MD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

August 22, 2006

First Submitted That Met QC Criteria