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The goal of this clinical trial is to learn which method of intravenous fluid works better for treating abnormal fetal heart rate patterns during labour in low-risk pregnant women at term. The main question it aims to answer is:
Does a rapid fluid bolus (500 mL given quickly) convert abnormal fetal heart rate tracings to normal within 30 minutes better than slow continuous infusion? Researchers will compare a 500 mL normal saline bolus followed by continuous infusion to continuous infusion alone to see which method improves fetal heart rate patterns faster.
Participants will:
Intravenous fluid is a key component of intrauterine resuscitation (IUR) for Category II fetal heart rate tracings. However, no randomised trial has compared bolus versus continuous infusion directly.
Intervention :
Both groups receive normal saline from a 1000 mL bag through a 21-gauge cannula. The bolus group receives the first 500 mL as a rapid free-flow infusion (IV bag positioned 110 cm above hand level), followed by the remaining 500 mL at 150 mL/h. The continuous group receives the full 1000 mL at 150 mL/h throughout. All participants also receive standard IUR: left lateral positioning, oxytocin discontinuation where applicable, and supplemental oxygen 10 L/min by face mask.
Outcome Assessment :
The primary outcome (EFM category at 30 minutes) is assessed by the attending physician from a separate room, blinded to group allocation. All EFM tracings are also independently re-adjudicated by two blinded reviewers after delivery.
Physiological Surrogates :
A single trained operator measures inferior vena cava collapsibility index (IVC-CI) by M-mode ultrasound and umbilical artery Doppler pulsatility index (UA PI) at baseline and 30 minutes to assess maternal volume status and fetoplacental resistance.
Statistical Analysis :
The primary analysis uses Fisher's exact test with risk difference, relative risk, and number needed to treat. Cumulative recovery is modelled by discrete-time survival analysis. A pre-specified BMI subgroup analysis and blinded re-adjudication sensitivity analysis are included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Bolus group): Receives 500 mL of normal saline intravenously as a bolus | Experimental | Receives 500 mL of normal saline intravenously as a bolus, followed by 1,000 mL normal saline at 150 mL/hour |
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| Group B (Continuous infusion group): Receives 1,000 mL of normal saline at 150 mL/hour | Experimental | Group B (Continuous infusion group): Receives 1,000 mL of normal saline at 150 mL/hour without a preceding bolus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 500 mL normal saline rapid bolus followed by remaining volume at 150 mL/hour | Drug | Participants receive 500 mL of normal saline as a rapid free-flow intravenous bolus through a 21-gauge cannula, with the IV bag positioned 110 cm above hand level. Once 500 mL is delivered, the remaining 500 mL from the same bag is continued at 150 mL/h. All infusions are continued until delivery or clinical decision to discontinue. |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery rate from Category II to Category I EFM tracing at 30 minutes | Proportion of participants with conversion from Category II to Category I electronic fetal monitoring (EFM) tracing within 30 minutes of intervention initiation, classified using the NICHD three-tier system. Recovery is defined as conversion to Category I. Non-recovery is defined as persistence of Category II or progression to Category III at 30 minutes. Classification is performed by the attending physician by real-time bedside assessment. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery rate from Category II to Category I EFM tracing at 60 minutes | Proportion of participants with conversion from Category II to Category I EFM tracing within 60 minutes of intervention initiation, using the same NICHD classification. Time Frame: | 60 minutes |
| Recovery rate from Category II to Category I EFM tracing at 120 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Savang Vadhana Memorial Hospital, Chon Buri, Chon Buri 20110 Recruiting | Si Racha | Changwat Chon Buri | 20110 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. World Health Organization. WHO statement on caesarean section rates. WHO/RHR/15.02. Geneva: World Health Organization; 2015. 2. Royal Thai College of Obstetricians Gynaecologists. Position Statement on Caesarean Section (Revised Edition 2023). Bangkok: RTCOG; 2023. 3. Freeman RK, Garite TJ, Nageotte MP, Miller LA. Fetal Heart Rate Monitoring. 4th ed. Philadelphia: Lippincott Williams & Wilkins; 2012. 4. Abati I, Micaglio M, Giugni D, Seravalli V, Vannucci G, Di Tommaso M. Maternal oxygen administration during labor: a controversial practice. Children. 2023;10(8):1420. 5. Kearney L, Craswell A, Dick N, Massey D, Nugent R. Evidence-based guidelines for intrapartum maternal hydration assessment and management: a scoping review. Birth. 2024;51(2):253-63. 6. Simpson KR, James DC. Efficacy of intrauterine resuscitation techniques in improving fetal oxygen status during labor. Obstetrics & Gynecology. 2005;105(6):1362-8. 7. Reddy UM, Weiner SJ, Saade GR, Varner MW, Blackwell SC, Thorp JM, Jr. Intrapartum resuscitation interventions for category II fetal heart rate tracings and improvement to category I. Obstetrics & Gynecology. 2021;138(3):409-16. 8. American College of Obstetrician Gynecologists. Practice Bulletin No. 116: Management of intrapartum fetal heart rate tracings. Obstetrics & Gynecology. 2010;116(5):1232-40. 9. Kitsricharoenchai A, Sunsaneevithayakul P, Boriboonhirunsarn D. Success rate of intrauterine fetal resuscitation in NICHD category II abnormal fetal heart rate pattern. Thai Journal of Obstetrics and Gynaecology. 2021;29(3):159-68. 10. Hopewell S, Chan A-W, Collins GS, Hróbjartsson A, Moher D, Schulz KF, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ. 2025;389:e081123. 11. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. 12. Manyara AM, Davies P, Stewa |
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Data was saved in form of Microsoft excel spreadsheet and SPSS file
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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.
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Participants were not informed of their group assignment. The attending physician who assessed EFM tracings at 30 minutes did so from a separate room without knowledge of treatment allocation. Two independent reviewers re-adjudicated all EFM tracings after delivery, blinded to allocation, real-time classification, and each other's assessments. The statistician received a locked dataset with coded group labels (A and B) and performed all analyses prior to unblinding. The resident and bedside nurse who administered the fluid were aware of the assigned infusion regimen and were not blinded.
|
Proportion of participants with conversion from Category II to Category I EFM tracing within 120 minutes of intervention initiation. |
| 120 minutes |
| Mode of delivery | Route of delivery classified as vaginal delivery or caesarean section. | At delivery |
| Neonatal Intensive Care Unit (NICU) admission | Proportion of neonates admitted to the neonatal intensive care unit following delivery. | Within 24 hours of delivery |
| Apgar score at 1 minute | Proportion of neonates with 1-minute Apgar score below 7 | 1 minute after delivery |
| Apgar score at 5 minutes | Proportion of neonates with 5-minute Apgar score below 7 | 5 minutes after delivery |
| ID | Term |
|---|---|
| D005316 | Fetal Distress |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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