Actively Recruiting

Phase Not Applicable
Age: 20Years - 35Years
FEMALE
NCT07260240

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

Age: 20Years - 35Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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)

AI-Screening

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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

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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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