The Effect of Warmed Parenteral Fluids During Delivery

March 7, 2019 updated by: hanoch schreiber, Meir Medical Center

The Effect of Warmed Parenteral Fluids During Vaginal Delivery and Cesarean Section

To evaluate the influence of warm IV fluids during delivery and cesarean section on perinatal outcomes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Prospective randomized controlled trial. Assessing the influence of warmed parenteral fluids during delivery/cesarean section on the obstetrical and neonatal outcome. The investigators will randomize parturients during the active phase of labor to receive either body temperature warmed parenteral fluids or room temperature parenteral fluids. Both groups will receive the same fluid composition of 5% dextrose with normal saline. The investigators will compare the obstetrical and neonatal outcomes of the two groups.

Study Type

Interventional

Enrollment (Anticipated)

7000

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 Contact

Study Contact Backup

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Recruiting
        • Meir Medical Center
        • Contact:

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

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Singleton pregnancies
  • term pregnancies
  • receiving parenteral fluids

Exclusion Criteria:

  • high order pregnancies
  • preterm pregnancies (before 37 weeks of gestation)
  • known fetal major anomaly
  • known fetal significant chromosomal/genetic abnormality

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Room temperature parenteral fluids

This group will receive IV room temperature fluids, which is the standard of care.

The composition of the fluids given will be normal saline with 5% dextrose.
Experimental: Body temperature parenteral fluids

This group will receive IV warmed fluids, body temperature, which is the experimental intervention.

The composition of the fluids given will be normal saline with 5% dextrose.
Other: Body temperature parenteral fluids
2 study groups shall receive the same parenteral fluids but at different temperatures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of the second stage of labor
Time Frame: up to 5 hours from complete cervical dilation
How much time did it take from complete cervical dilation to the delivery of the baby.
up to 5 hours from complete cervical dilation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of perineal tears and episiotomies
Time Frame: immediately after vaginal birth
The prevalence of perineal tears and episiotomies that occurred during vaginal delivery
immediately after vaginal birth
Neonatal APGAR score
Time Frame: up to 5 minutes from delivery
Comparison of the 1 minute and 5 minute APGAR score that the neonates received, between the groups.
up to 5 minutes from delivery
The rate of prolonged second stage
Time Frame: immediately after completion of the delivery.
The percentage of patients, in each group, that were defined with a prolonged second stage. The definition is more than 2 hours from complete cervical dilation until delivery of the baby in multipara patients and more than 3 hours from complete cervical dilation until delivery of the baby in nullipara patients.
immediately after completion of the delivery.

Collaborators and Investigators

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

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Hanoch Schreiber, MD, Clalit Health Services

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 (Actual)

July 1, 2017

Primary Completion (Anticipated)

December 30, 2019

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

May 30, 2017

First Submitted That Met QC Criteria

June 4, 2017

First Posted (Actual)

June 7, 2017

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 7, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0049-17-MMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All primary and secondary outcome measures will be made available within 6 months of syudy completion

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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