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

170 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare oxytocin infusion rates for induction and augmentation of labor in nulliparous women. The main question\[s\] it aims to answer are: * Does a high dose oxytocin infusion protocol affect length of induction to delivery interval? * Does a high dose oxytocin infusion protocol affect mode of delivery? * Does a high dose oxytocin infusion protocol affect maternal and neonatal outcomes? Participants will be randomized to either low- or high-dose oxytocin groups: * The low dose group will receive an infusion to start at 2 milli-units/min and will be increased by 2 milli-units/min every 20 minutes. The maximum rate of infusion is 40 milli-units/min. * The high dose group will receive an infusion to 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.

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 data supports the idea that Oxytocin Dosing for Prolonged Labor is an effective drug?

The available research shows that synthetic oxytocin, like Syntocinon, is effective in managing labor. One study found it to be as effective as natural oxytocin without any observed side effects, making it a recommended option when used correctly. Another study suggests that using oxytocin in a pulsatile manner can reduce the risk of negative effects for both mother and baby. However, a comparison with ambulation (walking around) showed that many women preferred ambulation due to less intense contractions, indicating that while oxytocin is effective, other methods might offer a more comfortable experience for some women. ^{1 2 3 4 5}

What data supports the effectiveness of the drug oxytocin for prolonged labor?

Research shows that synthetic oxytocin, like Syntocinon, is effective in managing labor by producing regular uterine activity. It is recommended to use low doses to reduce risks, and studies suggest it is as effective as natural oxytocin when used with proper supervision. ^{1 2 3 4 5}

What safety data exists for oxytocin use in labor?

Oxytocin, including its synthetic forms like Syntocinon and Pitocin, has been widely studied for use in labor. Studies show that when used correctly, oxytocin is effective and generally safe, with no significant side effects like vasospasm or anaphylactic reactions observed. However, misuse can lead to serious problems for both the mother and fetus. Safety measures such as standardized protocols, checklists, and trained staff are recommended to minimize risks. High-dose regimens have been shown to be safe, with no significant differences in adverse outcomes like fetal heart rate abnormalities or postpartum hemorrhage. Overall, oxytocin is safe when administered with proper supervision and dosage adjustments. ^{1 2 6 7 8}

Is oxytocin safe for use in humans?

Oxytocin, also known as Pitocin or Syntocinon, is generally considered safe when used correctly under medical supervision. Studies have shown that it can be used effectively in labor management without significant side effects, but misuse can lead to serious problems for both the mother and baby. Therefore, it is important to follow standardized protocols and closely monitor its administration. ^{1 2 6 7 8}

Is the drug Oxytocin a promising treatment for prolonged labor?

Yes, Oxytocin is a promising drug for prolonged labor. It is commonly used to help start or speed up labor, and studies show it can be effective when used correctly. A standardized approach to its use can improve safety and effectiveness, making it a valuable option for managing labor. ^{1 2 3 8 9}

How does the drug oxytocin differ from other treatments for prolonged labor?

Oxytocin is unique in its ability to induce or augment labor by mimicking the natural hormone that stimulates uterine contractions. Unlike other treatments, it can be administered in a pulsatile fashion, which reduces the risk of adverse effects for both the mother and fetus compared to continuous infusion. ^{1 2 3 8 9}

Research Team

Amanda Wang, MD

Principal Investigator

University of Texas

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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]

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]

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 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]

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]

References

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

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

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

Synthetic oxytocin. [2018]

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

Evolving concepts of oxytocin for induction of labor. [2005]

4. Ireland pubmed.ncbi.nlm.nih.gov

Ambulation versus oxytocin in protracted labour: a pilot study. [2019]

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

The use of oxytocin. [2018]

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

Outcomes of the Evidence-Based Pitocin Administration Checklist at a Tertiary-Level Hospital. [2018]

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

Oxytocin: physiology, pharmacology, and clinical application for labor management. [2023]

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

Improving patient safety and uniformity of care by a standardized regimen for the use of oxytocin. [2009]

9. England pubmed.ncbi.nlm.nih.gov

Induction of labour by pharmacological and physiological doses of intravenous oxytocin. [2019]