The Effect of Warmed Parenteral Fluids During Delivery

Not Applicable

• Conditions: Delivery, Obstetric
• Interventions: Other: Body temperature parenteral fluids

• Registration Number: NCT03178461
• Lead Sponsor: Meir Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-06-04
• Study First Posted: 2017-06-07
• Study Start: 2017-07-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-07
• Last Update Posted: 2019-03-08
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 7000

Inclusion Criteria

• Singleton pregnancies
• term pregnancies
• receiving parenteral fluids

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Body temperature parenteral fluids	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.

Primary Outcome Measures

Name	Time	Method
Length of the second stage of labor	up to 5 hours from complete cervical dilation	How much time did it take from complete cervical dilation to the delivery of the baby.

Secondary Outcome Measures

Name	Time	Method
Neonatal APGAR score	up to 5 minutes from delivery	Comparison of the 1 minute and 5 minute APGAR score that the neonates received, between the groups.
Prevalence of perineal tears and episiotomies	immediately after vaginal birth	The prevalence of perineal tears and episiotomies that occurred during vaginal delivery
The rate of prolonged second stage	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.

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel