The Effect of Warmed Parenteral Fluids During Delivery

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

Detailed Description
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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.

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

Conditions
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Delivery, Obstetric

Intervention / Treatment
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* Other: Body temperature parenteral fluids


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Room temperature parenteral fluids<br>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. | |
| Experimental: Body temperature parenteral fluids<br>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<br>* 2 study groups shall receive the same parenteral fluids but at different temperatures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of perineal tears and episiotomies | The prevalence of perineal tears and episiotomies that occurred during vaginal delivery | immediately after vaginal birth | 
| 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 | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caesarean Section, Delivery