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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether lowering the dose of oxytocin, a drug used during labor, can reduce the risk of slow fetal heart rates after administering pain relief through a spinal epidural. The trial compares the standard dose with a reduced dose to determine which is safer for the baby. Healthy women, pregnant with one baby and planning to use oxytocin during labor, may be suitable candidates for this study. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

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 is the safety track record for oxytocin?

Research has shown that oxytocin is usually safe during labor. It often helps start or speed up labor by strengthening contractions. However, studies have found that high doses can sometimes cause issues like excessive uterine tension and a slow heart rate in the baby. This trial tests a half-dose of oxytocin to see if it reduces these risks. Oxytocin is already FDA-approved for use in labor, indicating its safety when used correctly. Adjusting the dose might enhance safety for both mother and baby. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores the impact of reducing oxytocin dosage during labor to manage fetal bradycardia. Unlike the standard approach, which uses a full dose of oxytocin to induce or augment labor, this trial investigates whether cutting the dose in half could minimize the risk of fetal heart rate issues without compromising the effectiveness of labor induction. By potentially identifying a safer dosing strategy, the trial aims to improve outcomes for both mothers and babies during delivery.

What evidence suggests that reducing oxytocin might be effective for fetal bradycardia?

Research has shown that a lower dose of oxytocin can be as effective as a higher dose in aiding labor progression. Studies have found that a low-dose oxytocin plan reduces the risk of excessive contractions, which can be safer for both mother and baby. Evidence suggests that high doses of oxytocin might not significantly improve baby outcomes compared to standard care. In this trial, participants will receive either a standard dose or a half dose of oxytocin. The study aims to determine if reducing the oxytocin dose by half can lower the risk of changes in the baby's heart rate during labor. This approach might help prevent overly strong contractions and a slow baby heart rate. ^{1 2 3 6 7}

Who Is on the Research Team?

Unyime Ituk

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8932234/

High‐dose versus low‐dose oxytocin infusion regimens for ... The authors concluded that high‐dose oxytocin regimens were associated with a reduction in the length of labour and in caesarean section, and an increase in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03232918

NCT03232918 | Oxytocin and Fetal Heart Rate Changes The reported risk of nonreassuring fetal heart trace following neuraxial analgesia is 3-23%. This variability may be due to fluid and oxytocin management ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11278403/

High-Dose versus Low-Dose Oxytocin for Labor ... Labor augmentation with a low-dose oxytocin regimen is effective as with a high-dose regimen, but with significantly less uterine tachysystole events.

4. journals.lww.com journals.lww.com/md-journal/fulltext/2019/07120/uterine_hypertonus_and_fetal_bradycardia_occurred.24.aspx

Uterine hypertonus and fetal bradycardia occurred after... We herein present a case that uterine hypertonus and fetal bradycardia occurred after combined spinal-epidural (CSE) analgesia during induction of labor with ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/76/NCT00787176/Prot_SAP_000.pdf

The association between fluid administration, oxytocin ... In contrast, a study comparing high-dose oxytocin management with standard care found that there were no differences in fetal outcomes or the ...

6. clinicaltrial.be clinicaltrial.be/en/details/70941?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Oxytocin and Fetal Heart Rate Changes Oxytocin is used in labor and delivery to increase the frequency of contractions and augment uterine contractile strength, ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03232918/oxytocin-and-fetal-heart-rate-changes?state=IA&city=Carver

Oxytocin and Fetal Heart Rate Changes The reported risk of nonreassuring fetal heart trace following neuraxial analgesia is 3-23%. This variability may be due to fluid and ...