The Effect of Warmed Parenteral Fluids During Delivery

Clalit Health Services

Status: Unknown

Conditions: Delivery, Obstetric

Treatments: Other: Body temperature parenteral fluids

Study type: Interventional

Funder types: Other

Identifiers

NCT03178461

0049-17-MMC

Details and patient eligibility

About

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

Full 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.

Enrollment: 7,000 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7,000 participants in 2 patient groups

Room temperature parenteral fluids

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Body temperature parenteral fluids