IV bolus plus drip versus steady IV drip to help abnormal fetal heart tracings during labor
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
This trial tests whether a quick 500 mL IV fluid bolus followed by a steady drip or just a steady drip better turns a Category II fetal heart tracing into Category I within 30 minutes for women in labor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 35 Years |
| Sex | Female |
| Sponsor | Queen Savang Vadhana Memorial Hospital, Thailand Academic / other |
| Locations | 1 site (Si Racha, Changwat Chon Buri) |
| Trial ID | NCT07260240 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized controlled trial enrolls term women in labor with Category II fetal heart rate tracings and randomizes them by block randomization (block size = 4) to receive either a 500 mL normal saline bolus over 20 minutes followed by 1,000 mL at 150 mL/hr or 1,000 mL at 150 mL/hr alone. The primary outcome is conversion from Category II to Category I within 30 minutes as measured by continuous electronic fetal monitoring, with secondary measures including maternal hemodynamics, IVC collapsibility by ultrasound, umbilical artery Doppler indices, and FHR variability at baseline, 10, and 30 minutes. Interventions are delivered during active intrauterine resuscitation and outcomes are recorded in case report forms by blinded assessors. The trial is conducted at Queen Savang Vadhana Memorial Hospital in Chon Buri, Thailand, and enrolls low-risk term singleton pregnancies in cephalic presentation.
Who should consider this trial
Good fit: Ideal candidates are women in labor at term (≥37 weeks) with a singleton cephalic pregnancy, aged 20–35, who have a Category II fetal heart tracing and no major maternal or fetal complications.
Not a fit: Patients with significant maternal disease (cardiac, pulmonary, overt diabetes, thyroid disease), high-risk pregnancies (preeclampsia/eclampsia, gestational diabetes), fetal anomalies, oligohydramnios, or those receiving medications such as magnesium sulfate or opioids are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could provide a simple, low-cost way to reduce fetal distress and potentially avoid urgent interventions like emergency cesarean delivery.
How similar studies have performed: IV fluids are a standard part of intrauterine resuscitation, but randomized direct comparisons of a bolus plus drip versus drip alone are limited, making this a relatively novel head-to-head comparison.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Si Racha, Changwat Chon Buri
- Queen Savang Vadhana Memorial Hospital, Chon Buri, Chon Buri 20110 Recruiting — Si Racha, Changwat Chon Buri, Thailand (Recruiting)
Study contacts
- Study coordinator: Tawanrat Anannaweenusorn
- Email: Anantawanrat@gmail.com
- Phone: +66868162510
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.