An interventional study of Body temperature parenteral fluids in Delivery, Obstetric, sponsored by Meir Medical Center. Status unknown at 2 sites in Israel. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-08.
Sponsored by Meir Medical Center · Not applicable, Interventional, and Supportive care
To evaluate the influence of warm IV fluids during delivery and cesarean section on perinatal outcomes.
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.
Meir Medical Center is the lead sponsor of 389 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Length of the second stage of labor
How much time did it take from complete cervical dilation to the delivery of the baby.
Time frame: up to 5 hours from complete cervical dilation
Prevalence of perineal tears and episiotomies
The prevalence of perineal tears and episiotomies that occurred during vaginal delivery
Time frame: immediately after vaginal birth
Neonatal APGAR score
Comparison of the 1 minute and 5 minute APGAR score that the neonates received, between the groups.
Time frame: up to 5 minutes from delivery
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.
Time frame: immediately after completion of the delivery.
Plan to share: Yes — All primary and secondary outcome measures will be made available within 6 months of syudy completion
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Meir Medical Center