Actively Recruiting
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
Led by Queen Savang Vadhana Memorial Hospital, Thailand · Updated on 2025-12-03
60
Participants Needed
1
Research Sites
16 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Singleton pregnancy
- Thai nationality
- Gestational age 37 weeks or more
- Maternal age between 20 and 35 years
- Cephalic presentation (baby positioned head down)
- Electronic fetal monitoring Category II
You will not qualify if you...
- Maternal underlying diseases such as cardiac disease, pulmonary disease, overt diabetes mellitus, or thyroid disease
- High risk pregnancy including pre-eclampsia or eclampsia, and gestational diabetes mellitus
- Fetal abnormalities
- Maternal use of medications like magnesium sulfate, pethidine, or opioids
- Oligohydramnios (low amniotic fluid)
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Trial Site Locations
Total: 1 location
1
Queen Savang Vadhana Memorial Hospital, Chon Buri, Chon Buri 20110 Recruiting
Si Racha, Changwat Chon Buri, Thailand, 20110
Actively Recruiting
Research Team
T
Tawanrat Anannaweenusorn
CONTACT
P
Phanubhan Meepon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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