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Recovery Rate From Category II to Category I EFM Tracings in Pregnant Women Receiving Bolus vs Continuous Intravenous Fluid Administration

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

Last updated 2026-08-17

No results posted yet for this study

Summary

This randomized trial compared a normal saline bolus regimen with continuous normal saline infusion. The participants were low-risk pregnant women at term with Category II fetal heart rate tracings. Both groups were prescribed 1,000 mL of normal saline through the same volumetric infusion pump. The bolus group received 500 mL at 1,000 mL/h during the first 30 minutes, followed by 150 mL/h. The continuous group received 150 mL/h throughout. The primary outcome was first recovery from Category II to Category I within 30 minutes. Both groups also received standard intrauterine resuscitation. Fetal heart rate tracings were assessed at 30, 60, and 120 minutes.

Conditions

  • Category II Fetal Heart Rate Tracing

Interventions

DRUG

Normal saline bolus infusion

Participants were prescribed 1,000 mL of normal saline through a 21-gauge cannula and the same volumetric infusion pump. The first 500 mL was administered at 1,000 mL/h during the first 30 minutes. The remaining 500 mL was then administered at 150 mL/h. The intervention continued until the attending declared Category I recovery or until 120 minutes.

DRUG

Continuous normal saline infusion

Participants were prescribed 1,000 mL of normal saline through a 21-gauge cannula and the same volumetric infusion pump. Normal saline was administered continuously at 150 mL/h throughout. The intervention continued until the attending declared Category I recovery or until 120 minutes.

Sponsors & Collaborators

  • Queen Savang Vadhana Memorial Hospital, Thailand

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2026-03-27
Completion
2026-03-31

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