Oxytocin Dosing for Prolonged Labor

Overseen By Luis Pacheco, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: The University of Texas Medical Branch, Galveston

Must be taking: Oxytocin

Disqualifiers: Cervical ripening, Fetal demise, 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: Induction to delivery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different doses of oxytocin, a medication that helps initiate or accelerate labor, to assess its impact on delivery time, delivery type, and the health of both mother and baby. Participants will be randomly assigned to receive either a low or high dose of oxytocin through an IV. The trial seeks women expecting their first baby, with a single baby in the correct position, who require assistance in starting or accelerating labor with oxytocin. The researchers aim to determine the optimal use of oxytocin for a safer and potentially quicker delivery. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand how oxytocin can benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for oxytocin?

Research has shown that oxytocin, a drug commonly used to assist with childbirth, is generally safe but carries some risks. Studies have found that high doses of oxytocin can speed up labor but might also cause the uterus muscles to become too tight, leading to complications like severe bleeding after birth. However, other research found no significant differences in problems for mothers or babies when using doses above 20 milli-units/min.

Low-dose oxytocin is effective and has fewer risks, as it is less likely to cause the uterus to contract too often. The FDA has already approved oxytocin for helping start labor and control bleeding after childbirth. Still, using low doses might increase the risk of heavy bleeding after birth if labor lasts more than 4.5 hours.

In conclusion, while both high and low doses of oxytocin have been used safely for labor, they present different risks. High doses can speed up labor but may increase risks, while low doses are safer but might take longer. Discuss potential risks and benefits with a healthcare provider. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the oxytocin dosing protocol because it could refine how prolonged labor is managed. Unlike the standard approach, which typically involves a fixed increase in oxytocin dosage, this trial explores both high and low dosing strategies, allowing for a more tailored approach to inducing labor. This method aims to optimize uterine contractions more effectively, potentially leading to shorter labor durations and improved outcomes for both mothers and babies. By fine-tuning the dosing, the hope is to enhance safety and efficiency compared to traditional methods.

What evidence suggests that this trial's oxytocin dosing protocols could be effective for prolonged labor?

This trial will compare high-dose and low-dose oxytocin for prolonged labor. Research has shown that a high dose of oxytocin can shorten labor and reduce the need for a C-section. Studies also suggest it may result in more vaginal births and fewer infections for mothers and babies. However, high doses can increase the risk of excessive contractions. Conversely, a low dose of oxytocin is effective and causes fewer cases of excessive contractions. Both methods can initiate labor, but the choice affects delivery method and safety. ^{6 7 8 9 10}

Who Is on the Research Team?

Amanda Wang, MD

Principal Investigator

University of Texas

Are You a Good Fit for This Trial?

This trial is for first-time mothers aged 18-50, at least 37 weeks pregnant with one baby in the head-down position, and no prior uterine surgery. They must be presenting for labor induction or need help speeding up their labor. Women can't join if they have a non-reassuring fetal heart rate, allergy to oxytocin, certain pregnancy complications like growth restriction of the fetus, contraindications to vaginal delivery or previous cervical ripening treatments.

Inclusion Criteria

I am a woman aged between 18 and 50.

I have never had surgery on my uterus.

I need medication to help with labor.

Exclusion Criteria

Allergy to oxytocin

My pregnancy ended in loss or my baby was diagnosed with a severe condition.

I cannot have a baby through natural childbirth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either low-dose or high-dose oxytocin infusion for induction and augmentation of labor

Induction to delivery

Follow-up

Participants are monitored for maternal and neonatal outcomes, including mode of delivery and maternal side effects

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Oxytocin

Trial Overview The study compares low-dose versus high-dose oxytocin protocols for inducing and accelerating labor in women giving birth for the first time. One group will receive a starting dose of oxytocin at 2 milli-units/min increased every 20 minutes up to a max of 40 milli-units/min; the other starts at 6 milli-units/min with similar increases.

How Is the Trial Designed?

Group I: High dose oxytocin Active Control 1 Intervention

The high dose oxytocin group will receive a controlled infusion pump at a proximal port on the peripheral IV line. The infusion will start at 6 milli-units/min and will be increased by 6 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min. Oxytocin infusion rate is adjusted to maintain adequate uterine contractions.

Group II: Low dose oxytocin Active Control 1 Intervention

The low dose oxytocin group will receive a controlled infusion pump at a proximal port on the peripheral IV line. The infusion will start at 2 milli-units/min and will be increased by 2 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min. Oxytocin infusion rate is adjusted to maintain adequate uterine contractions.

Oxytocin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Pitocin for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

Approved in European Union as Syntocinon for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

Approved in Canada as Oxytocin for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

Published Research Related to This Trial

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]

The implementation of an evidence-based Pitocin administration checklist at a tertiary-level hospital significantly reduced the average duration of hospitalization from 2.02 days to 1.72 days, indicating improved efficiency in labor management.

The checklist also led to notable decreases in complications such as the presence of meconium (from 23.7% to 6.7%), maternal fevers (from 7.2% to 2.3%), and episiotomies (from 8.8% to 1.7%), suggesting enhanced safety and better birth outcomes for mothers and infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of the Evidence-Based Pitocin Administration Checklist at a Tertiary-Level Hospital. Wojnar, DM., Cowgill, K., Hoffman, L., et al.[2018]

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]

Oxytocin is effective in shortening labor and reducing the incidence of clinical chorioamnionitis when used in high-dose regimens as part of active labor management, based on randomized trials.

High-dose oxytocin is considered safe, with no significant differences in fetal heart rate abnormalities or other adverse outcomes, but requires careful administration and monitoring to prevent potential harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxytocin: physiology, pharmacology, and clinical application for labor management. Hermesch, AC., Kernberg, AS., Layoun, VR., et al.[2023]

Synthetic oxytocin is a safe and effective option for inducing regular uterine activity during labor, but it carries risks of water intoxication and hypotension due to its antidiuretic and vasoactive effects.

The authors recommend using low doses of dilute oxytocin with careful monitoring and gradual increases to minimize risks, advocating for the lowest effective dose to ensure safety for both mother and baby.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of oxytocin. Shyken, JM., Petrie, RH.[2018]

Intravenous oxytocin for labor induction should be administered at rates not exceeding 2 to 8 mU/min, as this dosage is crucial for safety and efficacy.

Pulsatile administration of oxytocin, starting at 1 mU/min and doubling every 24 minutes, is as effective as continuous infusion but requires lower peak levels and total doses, reducing the risk of adverse effects for both mother and fetus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving concepts of oxytocin for induction of labor. Dawood, MY.[2005]

A standardized protocol for oxytocin administration during labor induction was developed to enhance patient safety and reduce adverse maternal and fetal outcomes, based on a comprehensive literature review.

The proposed protocol includes a specific dilution of 10 mU/mL and a gradual dosing strategy, starting at 2 mU/min and increasing every 45 minutes, with a maximum dose of 16 mU/min, aiming to optimize the drug's efficacy while minimizing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety and uniformity of care by a standardized regimen for the use of oxytocin. Hayes, EJ., Weinstein, L.[2009]

In a study involving 278 patients, pharmacological doses of oxytocin (up to 422.4 mU/minute) were found to significantly improve induction-delivery intervals and reduce the incidence of failed inductions compared to physiological doses (2.6 to 13.2 mU/minute).

Both dosing groups had similar rates of hypertonus, indicating that higher doses of oxytocin do not increase the risk of this complication, while a target uterine activity of 200 to 220 Montevideo units is recommended for effective labor induction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction of labour by pharmacological and physiological doses of intravenous oxytocin. Toaff, ME., Hezroni, J., Toaff, R.[2019]

In a study of 57 women, 60% of those who were allowed to walk during labor delivered without the need for oxytocin, suggesting that ambulation may be an effective alternative for managing protracted labor.

Women in the ambulation group reported more positive experiences and had shorter second stages of labor, while those receiving oxytocin experienced stronger and more painful contractions, highlighting the potential benefits of allowing movement during labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulation versus oxytocin in protracted labour: a pilot study. Hemminki, E., Lenck, M., Saarikoski, S., et al.[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. ajogmfm.org ajogmfm.org/article/S2589-9333(25)00046-1/fulltext

Oxytocin regimen used for induction of labor and ... The risk for PPH is significantly higher for oxytocin ≥20 mU/min, irrespective of the duration of the labor.

3. mdpi.com mdpi.com/2075-4426/14/7/724

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. clinicaltrials.gov clinicaltrials.gov/study/NCT00957593

NCT00957593 | Induction of Labor With Oxytocin: When ... The primary outcome will be the rate of cesarean delivery between the groups. Secondary outcomes to be evaluated will include duration of the labor, fetal heart ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0267400

Comparison of delivery outcomes in low-dose and high-dose ... Implementation of the new continuous high-dose oxytocin protocol resulted in higher rate of vaginal delivery and lower rate of maternal and neonatal infections.

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

High-Dose versus Low-Dose Oxytocin for Labor ... High doses may shorten the duration of labor, but at the cost of potentially dangerous side effects. These include uterine hypertonicity (excessive muscle tone) ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36649339/

Maximum Dose Rate of Intrapartum Oxytocin Infusion and ... In multivariable analyses, there are no significant differences in maternal or perinatal adverse outcomes based on exceeding 20 milliunits/min of oxytocin.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0301211524000484

Cumulative oxytocin dose in spontaneous labour High cumulative oxytocin dose almost tripled cases of severe bleedings postpartum. Overdistended bladders were twice as common after high cumulative oxytocin ...

9. ahrq.gov ahrq.gov/patient-safety/settings/labor-delivery/perinatal-care/modules/strategies/medication/tool-safe-oxytocin.html

Safe Medication Administration: Oxytocin Labor augmentation with oxytocin may reduce time to delivery but has no impact on rate of Cesarean section or instrumental vaginal delivery. Several ...

10. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-020-02938-4

High dose and low dose oxytocin regimens as determinants of ... Higher successful induction (72.2% versus 61.1%) and lower Cesarean Section rate (27.8% vs. 38.9) were observed among participants who received ...