The Effect of Warmed Parenteral Fluids During Delivery

Delivery, Obstetric Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03178461
• Other study ID #: 0049-17-MMC
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: March 2019
• Source: Meir Medical Center
• Contact: Hanoch Schreiber, MD
• Phone: 972-53-332-3248
• Email: hanoch.schreiber[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Delivery, Obstetric

Intervention

Other:
• Body temperature parenteral fluids
2 study groups shall receive the same parenteral fluids but at different temperatures.

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevalence of perineal tears and episiotomies	The prevalence of perineal tears and episiotomies that occurred during vaginal delivery	immediately after vaginal birth
Secondary	Neonatal APGAR score	Comparison of the 1 minute and 5 minute APGAR score that the neonates received, between the groups.	up to 5 minutes from delivery
Secondary	The rate of prolonged second stage	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.