Reduced Oxytocin for Fetal Bradycardia
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Unyime Ituk
Must be taking: Oxytocin
Must not be taking: Chronic analgesics, Systemic opioids
Disqualifiers: Non-vertex presentation, others
No Placebo Group
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?The reported risk of nonreassuring fetal heart trace following neuraxial analgesia is 3-23%. This variability may be due to fluid and oxytocin management prior to and during the initiation of neuraxial analgesia. The study hypothesis is that decreasing the oxytocin infusion rate by 50 % prior to initiation of combined spinal epidural analgesia will cause a reduction in the incidence of adverse fetal heart rate changes.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use chronic pain medications.
What data supports the effectiveness of the drug oxytocin for fetal bradycardia?
Research shows that oxytocin, often used in labor, can effectively induce labor with reduced dosage when combined with another drug, prostaglandin E2, without side effects. Additionally, synthetic oxytocin has been found to be as effective as natural oxytocin in various obstetric uses, suggesting its potential effectiveness in managing fetal bradycardia.
12345Is reduced oxytocin safe for use in humans?
Synthetic oxytocin, used in many patients for various conditions, has shown no side effects like vasospasm (blood vessel spasm) or allergic reactions when used with proper supervision and dosage adjustment. However, misuse can lead to serious problems for both the mother and fetus, so careful administration is important.
12346How does the drug oxytocin differ from other treatments for fetal bradycardia?
The use of reduced oxytocin for fetal bradycardia is unique because it involves adjusting the dosage of a commonly used labor-inducing drug to address potential heart rate issues in the fetus. Unlike standard treatments that may not focus on dosage adjustments, this approach aims to minimize risks associated with oxytocin misuse, such as fetal distress, by carefully managing its administration.
12478Eligibility Criteria
This trial is for healthy pregnant women with a single baby at term (37 weeks or more), who want neuraxial analgesia for pain relief during labor and are already receiving oxytocin as per hospital guidelines. It's not open to those on chronic pain meds, who've had systemic opioid labor analgesia, have a baby in non-head-down position, or can't have an epidural due to other risks.Inclusion Criteria
I received oxytocin to help start or speed up my labor as per hospital guidelines.
I am a healthy woman at or past 37 weeks of pregnancy.
You are pregnant with only one baby.
+1 more
Exclusion Criteria
I cannot have spinal or epidural pain relief.
My baby's heart rate was category 3 before starting epidural pain relief.
I regularly use pain relief medication.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either standard or half dose oxytocin infusion prior to the initiation of combined spinal epidural analgesia
24 hours
In-hospital monitoring
Follow-up
Participants are monitored for fetal heart rate changes and maternal-fetal outcomes after treatment
1.5 hours
Continuous monitoring during labor
Participant Groups
The study is testing if reducing the rate of oxytocin infusion by half before starting combined spinal epidural analgesia lowers the risk of adverse changes in the baby's heart rate during birth.
2Treatment groups
Experimental Treatment
Active Control
Group I: Half Dose OxytocinExperimental Treatment1 Intervention
Patients randomized to the half dose oxytocin will have their oxytocin infusion reduced by 50 % prior to placement of a combined spinal epidural for labor analgesia.
Group II: Standard Dose OxytocinActive Control1 Intervention
Patients randomized to the standard dose oxytocin will have their oxytocin infusion maintained at the standard of care protocol prior to placement of a combined spinal epidural for labor analgesia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical College of WisconsinMilwaukee, WI
University of Iowa Hospitals and ClinicsIowa City, IA
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Who Is Running the Clinical Trial?
Unyime ItukLead Sponsor
References
Variations in oxytocin regimes in Scottish labour wards in 1998. [2004]Oxytocin (Syntocinon, Sandoz Pharmaceuticals) is a commonly used drug in the modern management of labour. A recently published British survey found that 38% of low risk primigravid labours were augmented, most commonly by intravenous syntocinon. Unfortunately the misuse of syntocinon can lead to potentially serious problems for the fetus and mother. Despite the frequency of usage there appears to be no consensus as to the optimal dose and mode of administration. This paper explores the extent of this variation among Scottish obstetric units, the reasons for any variation in its use and makes some suggestions as to the way forward based on the current literature.
Induction of labour by simultaneous intravenous administration of prostaglandin E 2 and oxytocin. [2019]In a group of 20 matched primigravid patients labour was induced by forewater amniotomy followed by intravenous oxytocin (Syntocinon) administered in escalating doses. Ten of these patients, in a double-blind trial, also received prostaglandin E(2) infused simultaneously with the oxytocin. In the combined prostaglandin-oxytocin group there was a noticeable reduction in the dosage of oxytocin required to produce effective uterine action, and the duration of labour was also reduced. No side effects were observed.
A randomised trial of carbetocin versus syntometrine in the management of the third stage of labour. [2021]Syntometrine is an effective uterotonic agent used in preventing primary postpartum haemorrhage but has adverse effects including nausea, vomiting, hypertension and coronary artery spasm. Carbetocin is a newly developed long-acting oxytocin analogue that might be used as an uterotonic agent. We compare the efficacy and safety of intramuscular (IM) carbetocin with IM syntometrine in preventing primary postpartum haemorrhage.
Synthetic oxytocin. [2018]A synthetic oxytocin, Syntocinon(R), was used in 3,342 obstetrical patients for a wide variety of indications. It was concluded that the preparation is as effective as natural oxytocin.(1) There were no side effects observed, particularly vasospasm or anaphylactic reaction. Its use in clinical obstetrics can be recommended provided there is a proper indication for its use and the need for close supervision and individual adjustment of dosage is recognized.
Carbetocin versus intra-umbilical oxytocin in the management of retained placenta: a randomized clinical study. [2017]This study aimed to compare the hemodynamic profile and efficacy of carbetocin versus intra-umbilical oxytocin in the management of retained placenta following vaginal delivery.
Oxytocin antagonists for the management of preterm birth: a review. [2014]Preterm birth, the leading cause of neonatal morbidity and mortality, is estimated at incidence of 12.7% of all births, which has not decreased over the last four decades despite intensive antenatal care programs aimed at high-risk groups, the widespread use of tocolytics, and a series of other preventive and therapeutic interventions. Oxytocin antagonists, namely atosiban, represent an appealing choice that seems to be effective with apparently fewer side effects than the traditional tocolytics. This article reviews the available literature on the pharmacokinetics, mode of administration, and clinical utility of oxytocin antagonists for acute and maintenance tocolysis with special emphasis on its safety profile.
The effect of oxytocin on porcine malignant hyperpyrexia susceptible skeletal muscle. [2019]1. Certain commercial preparations of oxytocin have been reported to reverse the development of pale soft exudative meat and malignant hyperpyrexia (MH) in pigs in vitro. 2. In this study it is shown that preservative-free oxytocin has no significant effect on the characteristic contractures of MH susceptible (MHS) muscle to halothane, caffeine, succinylcholine and KCl in vitro. 3. Whilst a commercial preparation of oxytocin, Syntocinon (containing chlorbutol as preservative), reversed and prevented the MHS characteristic responses, this study demonstrates conclusively that this was entirely due to the preservative chlorbutol.
Synthetic oxytocin as an antagonist of experimental cardiac anoxic changes in rabbits. [2019]Synthetic oxytocin (Syntocinon) can be shown to reduce or abolish ST-T changes induced experimentally by hypoxaemia alone, by hypoxaemia and ergometrine, by vasopressin, and by a new procedure involving injection of small doses of picrotoxin into the lateral cerebral ventricle. Ventricular fibrillation induced by picrotoxin can also be reversed by oxytocin. These effects suggest a probable metabolic action of oxytocin against cardiac anoxic changes, and its possible therapeutic usefulness as an antagonist of myocardial ischaemia. It is speculated that this might be a physiological action of the hormone.