NCT03178461

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
7,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

2.5 years

First QC Date

May 30, 2017

Last Update Submit

March 7, 2019

Conditions

Delivery, Obstetric

Keywords

Caesarean SectionDelivery

Outcome Measures

Primary Outcomes (1)

  • Length of the second stage of labor

    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 Outcomes (3)

  • Prevalence of perineal tears and episiotomies

    immediately after vaginal birth

  • Neonatal APGAR score

    up to 5 minutes from delivery

  • The rate of prolonged second stage

    immediately after completion of the delivery.

Study Arms (2)

Room temperature parenteral fluids

NO INTERVENTION

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.

Body temperature parenteral fluids

EXPERIMENTAL

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

Interventions

Body temperature parenteral fluidsOTHER

2 study groups shall receive the same parenteral fluids but at different temperatures.

Body temperature parenteral fluids

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly females are pregnant. The baby can be of either sex
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Singleton pregnancies
  • term pregnancies
  • receiving parenteral fluids

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Study Officials

  • Hanoch Schreiber, MD

    Clalit Health Services

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanoch Schreiber, MD

CONTACT

972-53-332-3248hanoch.schreiber@clalit.org.il

Tal Weissbach, MD

CONTACT

972-546-250-299ferbyt@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomization two 2 groups according to temperature of IV fluids. One group will receive room temperature fluids and the other group will receive body temperature fluids.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 7, 2017

Study Start

July 1, 2017

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

March 8, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

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

Locations

IL(2)