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Comparison of the Efficacy of Intravenous Fluid Administration Between Bolus and Continuous Infusion in Pregnant Women With Fetal Heart Rate Tracing Category II: A Randomized Controlled Trial
Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
Summary
The goal of this clinical trial is to compare the efficacy of two methods of intravenous (IV) fluid administration-bolus infusion versus continuous infusion-for intrauterine resuscitation in pregnant women who present with Category II fetal heart rate (FHR) tracings during labor. The main research question is: Does intrauterine resuscitation using an adjusted IV hydration bolus of normal saline more effectively convert the FHR tracing from Category II to Category I within 30 minutes compared to adjusted IV hydration using a continuous infusion of 1000 mL normal saline at 150 mL/hour? Objectives Primary Objective: \- To compare the rate of improvement of electronic fetal monitoring (EFM) category from Category II to Category I within 30 minutes between two hydration methods: Normal saline bolus loading (adjusted dose) Normal saline continuous infusion (1000 mL at 150 mL/hr) Secondary Objectives: * To identify the characteristics of IV fluid administration used during intrauterine resuscitation. * To determine whether fluid bolus improves fetal heart rate patterns more rapidly or effectively than continuous infusion. Methods Study Design: Randomized controlled trial with block randomization (block of four). Participants: Pregnant women in labor who present with Category II FHR tracing on admission. Intervention: Group A: Adjusted IV hydration with normal saline bolus loading. Group B: Adjusted IV hydration with normal saline continuous infusion (1000 mL at 150 mL/hr). Monitoring: Electronic fetal monitoring (EFM) will be continuously observed to detect any change in FHR category after intervention. Primary Outcome: Conversion of FHR from Category II to Category I within 30 minutes.
Key Details
Gender
FEMALE
Age Range
20 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-12-05
Completion Date
2026-03-30
Last Updated
2025-12-03
Healthy Volunteers
No
Conditions
Interventions
Giving 500 mL of normal saline intravenously as a bolus over 20 minutes, followed by 1,000 mL normal saline at 150 mL/hour
Giving 500 mL of normal saline intravenously as a bolus over 20 minutes, followed by 1,000 mL normal saline at 150 mL/hour which the another one will be giving 1,000 mL of normal saline at 150 mL/hour without a preceding bolus.
Locations (1)
Queen Savang Vadhana Memorial Hospital, Chon Buri, Chon Buri 20110 Recruiting
Si Racha, Changwat Chon Buri, Thailand