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 (Bolus fluid)

Queen Savang Vadhana Memorial Hospital, Thailand

Status: Enrolling

Conditions: Fetal Non Reassuring

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT07260240

013/2568

Details and patient eligibility

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.

Full description

This is a randomized controlled trial study 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

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Singleton
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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

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

Description:

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

Treatment:

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