Recovery Rate From Category II to Category I EFM Tracings in Pregnant Women Receiving Bolus vs Continuous Intravenous Fluid Administration
Summary
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: * Be placed in the left lateral position and receive supplemental oxygen by face mask * Have oxytocin stopped if it is being given * Receive normal saline through an IV line - either as a rapid bolus or a slow continuous drip, depending on which group they are assigned to * Have fetal heart rate monitored continuously and assessed at 30, 60, and 120 minutes * Have blood pressure, heart rate, and oxygen levels checked every 15 minutes * Have two ultrasound measurements taken - one of a vein in the abdomen and one of blood flow in the umbilical cord - at the start and at 30 minutes
Timeline
- Start
- 2025-12-10
- Primary completion
- 2026-03-27
- Completion
- 2026-03-31
Publications
- 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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sodium chloride | Unknown | 500 ml | Intravenous |
| Subject | sodium chloride | Unknown | 1000 ml | Intravenous |
Indications
No indication recorded.