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

NCT07260240 | Recruiting DMC

• 1 other identifier: 013/2568
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fetal Non Reassuring

Keywords

Bolus fluid administration, Non-reassuring fetal status, Fetal distress, Intrauterine resuscitation

Outcome Measures

Primary Outcomes (1)

• To compare the rate of improvement of electronic fetal monitoring (EFM) category from Category II to Category I within 30 minutes

  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: 1. Normal saline bolus loading (adjusted dose) 2. Normal saline continuous infusion (1000 mL at 150 mL/hr)

  30 minutes

Study Arms (2)

Group A (Bolus group): Receives 500 mL of normal saline intravenously as a bolus

EXPERIMENTAL

Receives 500 mL of normal saline intravenously as a bolus over 20 minutes, followed by 1,000 mL normal saline at 150 mL/hour

Drug: Giving 500 mL of normal saline intravenously as a bolus over 20 minutes, followed by 1,000 mL normal saline at 150 mL/hour

Group B (Continuous infusion group): Receives 1,000 mL of normal saline at 150 mL/hour

EXPERIMENTAL

Group B (Continuous infusion group): Receives 1,000 mL of normal saline at 150 mL/hour without a preceding bolus

Drug: Giving 500 mL of normal saline intravenously as a bolus over 20 minutes, followed by 1,000 mL normal saline at 150 mL/hour

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 DRUG

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 A (Bolus group): Receives 500 mL of normal saline intravenously as a bolus; Group B (Continuous infusion group): Receives 1,000 mL of normal saline at 150 mL/hour

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton
• Thai nationality
• Gestational Age more than equal 37 Weeks
• Maternal Age 20-35 Years
• Cephalic Presentation
• Electronic Fetal Monitoring (EFM) Category II

You may not qualify if:

• Maternal underlying diseases : Cardiac disease, Pulmonary disease), Overt DM, Thyroid disease,. etc
• High risk pregnancy :Pre-eclampsia/Eclampsia), GDM
• Fetal abnormalities
• Maternal receiving medications for example : Magnesium sulfate, Pethidine, Opioids
• Oligohydramnios

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

Study Sites (1)

Queen Savang Vadhana Memorial Hospital, Chon Buri, Chon Buri 20110 Recruiting

Si Racha, Changwat Chon Buri, 20110, Thailand

RECRUITING

MeSH Terms

Conditions

Fetal Distress

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tawanrat Anannaweenusorn

CONTACT

+66868162510; Anantawanrat@gmail.com

Phanubhan Meepon

CONTACT

+66643644653; t_op038@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients were divided into two groups using computer-generated block 0f-four randomization. The experimental group receives 500 mL of normal saline intravenously as a bolus in 30 minutes, followed by 1,000 mL normal saline at 150 mL/hour, while the control group receives 1,000 mL of normal saline at 150 mL/hour without a preceding bolus.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 3, 2025
• Study Start: December 5, 2025
• Primary Completion: December 30, 2025
• Study Completion: March 30, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

TH (1)