Reduced Oxytocin for Fetal Bradycardia

Recruiting at 1 trial location

Overseen By Unyime Ituk

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Unyime Ituk

Must be taking: Oxytocin

Must not be taking: Chronic analgesics, Systemic opioids

Disqualifiers: Non-vertex presentation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 hours

730 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 4 6}

How 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. ^{1 2 4 7 8}

Research Team

Unyime Ituk

Principal Investigator

University of Iowa

Eligibility 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.

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.

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

Treatment Details

Interventions

• Oxytocin

Trial Overview 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.

Participant Groups

Group I: Half Dose Oxytocin Experimental Treatment 1 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 Oxytocin Active Control 1 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

Who Is Running the Clinical Trial?

Unyime Ituk

Lead Sponsor

Trials

1

Recruited

730+

Findings from Research

Oxytocin is widely used to augment labor in low-risk first-time mothers, with a survey indicating that 38% of such labors in the UK are treated with intravenous syntocinon.

There is significant variation in the dosing and administration of syntocinon across Scottish obstetric units, which raises concerns about potential risks to both mothers and fetuses due to misuse, highlighting the need for standardized guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variations in oxytocin regimes in Scottish labour wards in 1998. Arnott, N., Harrold, AJ., Lynch, P.[2004]

In a study of 20 first-time mothers, the combination of prostaglandin E(2) and oxytocin during labor induction significantly reduced the amount of oxytocin needed for effective uterine contractions.

The use of prostaglandin E(2) also shortened the duration of labor without any observed side effects, suggesting a safe and effective approach to labor induction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction of labour by simultaneous intravenous administration of prostaglandin E 2 and oxytocin. Naismith, WC., Barr, W., MacVicar, J.[2019]

Carbetocin is as effective as syntometrine in preventing primary postpartum hemorrhage, with no significant difference in hemoglobin drop or the need for additional oxytocic injections among 329 women studied.

Carbetocin has a lower incidence of adverse effects such as nausea, vomiting, and hypertension compared to syntometrine, making it a safer alternative for managing the third stage of labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised trial of carbetocin versus syntometrine in the management of the third stage of labour. Leung, SW., Ng, PS., Wong, WY., et al.[2021]

Syntocinon(R), a synthetic form of oxytocin, was found to be as effective as natural oxytocin in a study involving 3,342 obstetrical patients.

The use of Syntocinon(R) showed no significant side effects, such as vasospasm or anaphylactic reactions, suggesting it is safe for clinical use in obstetrics when properly indicated and monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthetic oxytocin. HIBBARD, LT., ANDREWS, AV.[2018]

Carbetocin was found to be more effective than intra-umbilical oxytocin for expelling the placenta, with a success rate of 86.84% compared to 77.5% in the oxytocin group, based on a study involving 78 women with retained placenta.

Both treatments were similarly effective in reducing the need for manual removal of the placenta, but carbetocin demonstrated a better hemodynamic safety profile, as it did not significantly lower blood pressure like oxytocin did.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbetocin versus intra-umbilical oxytocin in the management of retained placenta: a randomized clinical study. Elfayomy, AK.[2017]

Preterm birth remains a significant issue, affecting 12.7% of all births, and current interventions have not successfully reduced this rate over the past 40 years.

Oxytocin antagonists like atosiban show promise as effective tocolytics with potentially fewer side effects compared to traditional treatments, making them a safer option for managing preterm labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxytocin antagonists for the management of preterm birth: a review. Usta, IM., Khalil, A., Nassar, AH.[2014]

Preservative-free oxytocin does not significantly affect the muscle contractures associated with malignant hyperpyrexia in pigs, indicating it may not be effective for this condition.

The commercial preparation Syntocinon, which contains the preservative chlorbutol, was able to reverse the muscle responses related to malignant hyperpyrexia, but this effect is attributed solely to the chlorbutol, not the oxytocin itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of oxytocin on porcine malignant hyperpyrexia susceptible skeletal muscle. Sim, AT., White, MD., Denborough, MA.[2019]

Synthetic oxytocin (Syntocinon) has been shown to effectively reduce or eliminate ST-T changes in the heart caused by various conditions, including hypoxia and the administration of ergometrine, indicating its potential protective effects on cardiac function.

Oxytocin can reverse ventricular fibrillation induced by picrotoxin, suggesting it may have a therapeutic role in counteracting myocardial ischemia and supporting its physiological action in protecting the heart during low oxygen conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthetic oxytocin as an antagonist of experimental cardiac anoxic changes in rabbits. MELVILLE, KI., VARMA, DR.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Variations in oxytocin regimes in Scottish labour wards in 1998. [2004]

2. England pubmed.ncbi.nlm.nih.gov

Induction of labour by simultaneous intravenous administration of prostaglandin E 2 and oxytocin. [2019]

3. England pubmed.ncbi.nlm.nih.gov

A randomised trial of carbetocin versus syntometrine in the management of the third stage of labour. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Synthetic oxytocin. [2018]

5. Australia pubmed.ncbi.nlm.nih.gov

Carbetocin versus intra-umbilical oxytocin in the management of retained placenta: a randomized clinical study. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Oxytocin antagonists for the management of preterm birth: a review. [2014]

7. Australia pubmed.ncbi.nlm.nih.gov

The effect of oxytocin on porcine malignant hyperpyrexia susceptible skeletal muscle. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Synthetic oxytocin as an antagonist of experimental cardiac anoxic changes in rabbits. [2019]