Category II Fetal Heart Rate TracingIUR-RCTNCT07260240
Recovery Rate From Category II to Category I EFM Tracings in Pregnant Women Receiving Bolus vs Continuous Intravenous Fluid Administration
A study testing Normal saline bolus infusion and Continuous normal saline infusion in people with Category II Fetal Heart Rate Tracing, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Category II Fetal Heart Rate Tracing
- What is being tested?
- Normal saline bolus infusion and Continuous normal saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 10 Dec 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Queen Savang Vadhana Memorial Hospital
Si Racha, Changwat Chon Buri, 20110
About this study
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.
Read the detailed description
Intravenous fluid is a component of intrauterine resuscitation for Category II fetal heart rate tracings. No randomized trial had directly compared bolus and continuous intravenous fluid administration.
Both arms were prescribed 1,000 mL of normal saline through a 21-gauge cannula and the same volumetric infusion pump. The bolus group received 500 mL at 1,000 mL/h during the first 30 minutes. The remaining 500 mL was then administered at 150 mL/h. The continuous group received 150 mL/h throughout. Programmed delivery by 30 minutes was approximately 500 mL in the bolus group and 75 mL in the continuous group. Resuscitation continued until the attending declared Category I recovery or until 120 minutes.
Both groups received standard intrauterine resuscitation. This included left lateral positioning, oxytocin discontinuation where applicable, and oxygen at 10 L/min through a face mask.
The primary outcome was first recovery from Category II to Category I within 30 minutes. First Category I recovery was an absorbing endpoint. A later observed Category II classification did not reverse recovered endpoint status. The participant and attending outcome assessor were masked to allocation. Two masked reviewers independently re-adjudicated the fetal heart rate classifications.
A trained operator measured the inferior vena cava collapsibility index and umbilical artery Doppler pulsatility index at baseline and 30 minutes. The primary analysis used Fisher's exact test, risk difference, relative risk, and number needed to treat.
- Conditions
- Category II Fetal Heart Rate Tracing
- Being tested
- Normal saline bolus infusion, Continuous normal saline infusion
- Keywords
- bolus intravenous fluid administration, continuous intravenous fluid administration, Category II fetal heart rate tracing, electronic fetal monitoring, intrauterine resuscitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal saline bolus infusionDrug
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.
Continuous normal saline infusionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Continuous normal saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (6)
First recovery from Category II to Category I EFM tracing within 60 minutes
Cumulative proportion of participants with first recovery from Category II to Category I electronic fetal monitoring tracing within 60 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 by 60 minutes was persistent Category II or progression to Category III.
Measured: 60 minutes
First recovery from Category II to Category I EFM tracing within 120 minutes
Cumulative proportion of participants with first recovery from Category II to Category I electronic fetal monitoring tracing within 120 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 by 120 minutes was persistent Category II or progression to Category III.
Measured: 120 minutes
Mode of delivery
Route of delivery classified as vaginal delivery or caesarean section.
Measured: At delivery
Neonatal Intensive Care Unit (NICU) admission
Proportion of neonates admitted to the neonatal intensive care unit following delivery.
Measured: Within 24 hours of delivery
Apgar score at 1 minute
Proportion of neonates with 1-minute Apgar score below 7
Measured: 1 minute after delivery
Apgar score at 5 minutes
Proportion of neonates with 5-minute Apgar score below 7
Measured: 5 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start10 Dec 2025
- Primary completion27 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Category II Fetal Heart Rate TracingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260240
- Sponsor's protocol ID
- 013/2568
- Acronym
- IUR-RCT
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data that underlie the reported results may be available from the corresponding author. Direct identifiers will not be shared. Participant confidentiality and the Thailand Personal Data Protection Act B.E. 2562 (2019) will apply.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Rate From Category II to Category I EFM Tracings in Pregnant Women Receiving Bolus vs Continuous Intravenous Fluid Administration
- ClinicalTrials.gov ID
- NCT07260240
- Acronym / sponsor ID
- IUR-RCT / 013/2568
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intravenous fluid is a component of intrauterine resuscitation for Category II fetal heart rate tracings. No randomized trial had directly compared bolus and continuous intravenous fluid administration.
Both arms were prescribed 1,000 mL of normal saline through a 21-gauge cannula and the same volumetric infusion pump. The bolus group received 500 mL at 1,000 mL/h during the first 30 minutes. The remaining 500 mL was then administered at 150 mL/h. The continuous group received 150 mL/h throughout. Programmed delivery by 30 minutes was approximately 500 mL in the bolus group and 75 mL in the continuous group. Resuscitation continued until the attending declared Category I recovery or until 120 minutes.
Both groups received standard intrauterine resuscitation. This included left lateral positioning, oxytocin discontinuation where applicable, and oxygen at 10 L/min through a face mask.
The primary outcome was first recovery from Category II to Category I within 30 minutes. First Category I recovery was an absorbing endpoint. A later observed Category II classification did not reverse recovered endpoint status. The participant and attending outcome assessor were masked to allocation. Two masked reviewers independently re-adjudicated the fetal heart rate classifications.
A trained operator measured the inferior vena cava collapsibility index and umbilical artery Doppler pulsatility index at baseline and 30 minutes. The primary analysis used Fisher's exact test, risk difference, relative risk, and number needed to treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A: Bolus group | Experimental | Drug: Normal saline bolus infusionParticipants 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. |
| Group B: Continuous group | Experimental | Drug: Continuous normal saline infusionParticipants 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Singleton pregnancy
- Thai nationality
- Gestational age of 37 weeks or more
- Maternal age from 20 to 35 years
- Cephalic presentation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal saline bolus infusionParticipants 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 | Group A: Bolus group |
| Continuous normal saline infusionParticipants 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. | Drug | Group B: Continuous group |
Primary outcome
First recovery from Category II to Category I EFM tracing within 30 minutes
Time frame: 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.
6 secondary outcomes
First recovery from Category II to Category I EFM tracing within 60 minutes
Time frame: 60 minutes
First recovery from Category II to Category I EFM tracing within 120 minutes
Time frame: 120 minutes
Mode of delivery
Time frame: At delivery
Neonatal Intensive Care Unit (NICU) admission
Time frame: Within 24 hours of delivery
Apgar score at 1 minute
Time frame: 1 minute after delivery
Apgar score at 5 minutes
Time frame: 5 minutes after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data that underlie the reported results may be available from the corresponding author. Direct identifiers will not be shared. Participant confidentiality and the Thailand Personal Data Protection Act B.E. 2562 (2019) will apply.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline bolus infusion and Continuous normal saline infusion in people with Category II Fetal Heart Rate Tracing, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First recovery from Category II to Category I EFM tracing within 30 minutes (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.