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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

NCT07260240 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-03

No results posted yet for this study

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

Interventions

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

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.

Sponsors & Collaborators

  • Queen Savang Vadhana Memorial Hospital, Thailand

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-05
Primary Completion
2025-12-30
Completion
2026-03-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07260240 on ClinicalTrials.gov