Delivery, Obstetric
Conditions
Keywords
Caesarean Section, Delivery
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.
Interventions
OTHERBody temperature parenteral fluids
2 study groups shall receive the same parenteral fluids but at different temperatures.
Sponsors
Meir Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of perineal tears and episiotomies | immediately after vaginal birth | The prevalence of perineal tears and episiotomies that occurred during vaginal delivery |
| 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. |
| 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. |
Countries
Israel
Contacts
Primary ContactHanoch Schreiber, MD
Backup ContactTal Weissbach, MD
Outcome results
None listed