drugset / Trial / NCT07260240

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

NCT07260240

RandomizedParallel-groupDouble-blindTreatment

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

EvaluationDrugModalityDoseRoute
Subject sodium chloride Unknown 500 ml Intravenous
Subject sodium chloride Unknown 1000 ml Intravenous

Indications

No indication recorded.