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
NCT ID: NCT07260240
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-12-05
2026-03-30
Brief Summary
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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.
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Detailed Description
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There are 2 interventions :
Intervention 1 (Bolus Group):
Participants receive 500 mL of normal saline (NSS) intravenously as a bolus over 20 minutes, followed by 1,000 mL of NSS infused continuously at 150 mL/hour.
Intervention 2 (Continuous Infusion Group):
Participants receive 1,000 mL of normal saline infused continuously at 150 mL/hour without a preceding bolus.
Short-term Outcome Collection
Primary short-term outcome:
Conversion of FHR Category II to Category I within 30 minutes after starting the assigned IV hydration regimen, assessed by continuous electronic fetal monitoring (EFM).
Secondary short-term outcomes:
Measured at baseline, 10 minutes, and 30 minutes after intervention:
Maternal hemodynamic parameters: Blood pressure, heart rate, respiratory rate, SpO₂ IVC collapsibility index (IVC-CI) assessed by ultrasound (M-mode) Umbilical artery Doppler indices: Resistance Index (RI), Pulsatility Index (PI), S/D ratio FHR variability and deceleration pattern All outcomes are recorded in the Case Record Form (CRF) by blinded assessors. All participants are women in labor with Category II fetal heart rate (FHR) tracing, randomized by block randomization (block size = 4).
During the intervention, standard intrauterine resuscitation measures (maternal left lateral position, discontinuation of oxytocin, oxygen 15 L/min by mask if indicated) are maintained uniformly.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Group A (Bolus group): Receives 500 mL of normal saline intravenously as a bolus
Receives 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
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.
Group B (Continuous infusion group): Receives 1,000 mL of normal saline at 150 mL/hour
Group B (Continuous infusion group): Receives 1,000 mL of normal saline at 150 mL/hour without a preceding bolus
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Thai nationality
3. Gestational Age more than equal 37 Weeks
4. Maternal Age 20-35 Years
5. Cephalic Presentation
6. Electronic Fetal Monitoring (EFM) Category II
Exclusion Criteria
2. High risk pregnancy :Pre-eclampsia/Eclampsia), GDM
3. Fetal abnormalities
4. Maternal receiving medications for example : Magnesium sulfate, Pethidine, Opioids
5. Oligohydramnios
20 Years
35 Years
FEMALE
No
Sponsors
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Queen Savang Vadhana Memorial Hospital, Thailand
OTHER
Responsible Party
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Locations
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Queen Savang Vadhana Memorial Hospital, Chon Buri, Chon Buri 20110 Recruiting
Si Racha, Changwat Chon Buri, Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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013/2568
Identifier Type: -
Identifier Source: org_study_id
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