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

NCT07260240 | Completed DMC

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

Brief 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

Keywords

bolus intravenous fluid administration; continuous intravenous fluid administration; Category II fetal heart rate tracing; electronic fetal monitoring; intrauterine resuscitation

Outcome Measures

Primary Outcomes (1)

• First recovery from Category II to Category I EFM tracing within 30 minutes

  Proportion of participants with first recovery from Category II to Category I electronic fetal monitoring tracing within 30 minutes of intervention initiation, classified using the NICHD three-tier system. First Category I recovery was an absorbing endpoint. A later observed Category II classification did not reverse recovered endpoint status. Non-recovery was persistent Category II or progression to Category III. Classification was performed in real time by the masked attending outcome assessor.

  30 minutes

Secondary Outcomes (6)

• First recovery from Category II to Category I EFM tracing within 60 minutes

  60 minutes

• First recovery from Category II to Category I EFM tracing within 120 minutes

  120 minutes

• Mode of delivery

  At delivery

• Neonatal Intensive Care Unit (NICU) admission

  Within 24 hours of delivery

• Apgar score at 1 minute

  1 minute after delivery

Study Arms (2)

Group A: Bolus group

EXPERIMENTAL

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. Resuscitation continued until the attending declared Category I recovery or until 120 minutes.

Drug: Normal saline bolus infusion

Group B: Continuous group

EXPERIMENTAL

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

Drug: Continuous normal saline infusion

Interventions

Normal saline bolus infusion DRUG

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.

Group A: Bolus group

Continuous normal saline infusion DRUG

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.

Group B: Continuous group

Eligibility Criteria

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

You may qualify if:

• Singleton pregnancy
• Thai nationality
• Gestational age of 37 weeks or more
• Maternal age from 20 to 35 years
• Cephalic presentation
• Category II electronic fetal monitoring tracing during labor

You may not qualify if:

• Pre-existing cardiac, pulmonary, thyroid, or overt diabetic disease
• Pre-eclampsia or gestational diabetes
• Suspected fetal structural anomaly, growth restriction, arrhythmia, or chromosomal abnormality
• Recent magnesium sulfate or opioid analgesia
• Oligohydramnios

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

Study Sites (1)

Queen Savang Vadhana Memorial Hospital

Si Racha, Changwat Chon Buri, 20110, Thailand

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were not informed of their group assignment. The attending physician assessed EFM tracings from a separate room without knowledge of allocation. Two independent reviewers re-adjudicated the baseline and 30-minute EFM tracings after delivery. They were masked to allocation, real-time classification, and each other's assessments. The statistician received coded group labels before unblinding. The resident and bedside nurse were not masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm parallel-group randomised controlled trial with 1:1 allocation ratio. Participants were randomly assigned to either intravenous fluid bolus or continuous infusion and remained in their assigned group throughout the study.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 3, 2025
• Study Start: December 10, 2025
• Primary Completion: March 27, 2026
• Study Completion: March 31, 2026
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Requests will be considered after publication of the primary results. No fixed end date is planned.
• Access Criteria: Qualified researchers must submit a written request to the corresponding author. The request must include a research proposal, requested variables, planned analyses, and evidence of ethics approval. Access requires institutional review board approval and a signed data use agreement. Approved data must remain secure and cannot be used to identify participants. Use must comply with the Thailand Personal Data Protection Act B.E. 2562 (2019).

Locations

TH (1)