Intrapartum Hydration

February 20, 2016 updated by: Raed Salim, HaEmek Medical Center, Israel
The purpose of this study is to determine that maternal hydration during labor with fluids containing glucose at a rate of 125 ml per hour does not affect the duration of labor compared to Ringer Lactate at a rate of 250 ml per hour.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During labor it is a common practice that the parturient is fastening and having fluid replacement through intravenous hydration (IVH), the rational being to avoid aspiration of gastric content in a situation of need for urgent intervention and general anesthesia with tracheal intubation. It is acceptable to infuse 125 ml per hour of a physiological solution that does not contain sugar, but the volume is not adjusted to the weight of mother, the level of effort or relaxation she is experiencing and it may well be below the required amount. From studies in the field of sport medicine it is clear that the amount of fluid reaching the muscle has an impact on the efficiency of the muscle at the level of tissue and the level of personal achievement in sports. Only few studies dealt with the amount and contents of IVH during labor that will be sufficient and meet all physiologic requirements of the parturient and her fetus.

Study Type

Interventional

Enrollment (Actual)

300

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

  • Israel
      • Afula, Israel
        • Dep OB/GYN, HaEmek Medical Center

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Nulliparous women
  • Gestational age 37-41 weeks
  • Cervical dilatation 1-3 cm
  • Vertex presentation
  • Singleton

Exclusion Criteria:

  • Diabetes
  • Preeclampsia
  • Intra uterine fetal growth restriction
  • Duration of labor less than an hour
  • Maternal chronic disease
  • Maternal fever upon admission.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 0.9% Saline with glucose 5%
rate of infusion is 125cc/h
Other: 0.9% Saline with glucose 5%
intravenous hydration at a rate of 125 ml per hour during labor
Active Comparator: Ringer lactate
rate of infusion is 250cc/h
Other: Ringer lactate
intravenous hydration at a rate of 250 ml per hour during labor
Active Comparator: Ringer lactate - Controls
rate of infusion is 125cc/h
Other: Ringer lactate - Controls
intravenous hydration at a rate of 125 ml per hour during labor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of time from enrollment until delivery
Time Frame: within the first 48 hours after delivery
within the first 48 hours after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Mode of delivery
Time Frame: within the first 48 hours after delivery
within the first 48 hours after delivery
Neonatal outcome
Time Frame: within the first 48 hours after delivery
within the first 48 hours after delivery

Collaborators and Investigators

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

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: Raed Salim, MD, Dep. OB/GYN, HaEmek Medical Center, Afula, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2010

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 15, 2010

First Submitted That Met QC Criteria

November 15, 2010

First Posted (Estimate)

November 17, 2010

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 20, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 0062-10-EMC
  • IH-1 (Other Identifier: 0062-10-EMC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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