Oxytocin for Labor Complications

(ROSSoL Trial)

Recruiting at 1 trial location

Overseen By Nandini Raghuraman, MD MSCI

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must be taking: Oxytocin

Disqualifiers: Multiple gestations, Multiparous, Major fetal anomalies, others

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

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether oxytocin, a hormone that aids contractions, is beneficial during the second stage of labor. Participants will either continue or stop oxytocin to determine its effect on labor complications. The trial targets women having their first baby who are at least 37 weeks pregnant. Women expecting one baby and admitted for labor, whether naturally or induced, may qualify. The goal is to make labor safer and more effective. As an unphased trial, this study allows participants to contribute to important research that could enhance labor outcomes for many women.

Do I need to stop my current medications to join the trial?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that oxytocin can pose safety concerns, especially in high amounts. Studies have found that high doses can lead to issues like uterine tears, excessive muscle tension, and muscle spasms during labor.

Further research indicates that oxytocin use can cause complications for the uterus, mother, or baby. For instance, using more than 20 milliunits per minute during labor can increase the risk of heavy bleeding after birth, particularly if labor exceeds 4.5 hours. Additionally, a high total dose of oxytocin during labor has been linked to more severe postpartum bleeding.

While oxytocin often assists with labor, awareness of these potential risks is important. Discuss the benefits and risks with healthcare providers to understand your specific situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the traditional approach of either using or discontinuing oxytocin during labor, this trial explores the effects of continuing versus discontinuing oxytocin to manage labor complications. Researchers are excited because this could provide insights into optimizing oxytocin use, potentially improving outcomes for mothers and babies. The trial aims to determine the safest and most effective way to use oxytocin, a common labor-inducing drug, which could lead to better guidelines for managing labor complications.

What evidence suggests that this trial's treatments could be effective for labor complications?

Research has shown that oxytocin can reduce the risk of heavy bleeding after childbirth, known as postpartum hemorrhage. Studies have found that it significantly lowers this risk compared to no treatment. In this trial, participants will either continue or discontinue oxytocin to assess its effects. Using oxytocin during active labor can shorten the time to give birth by about two hours. Thus, oxytocin not only helps manage possible complications but also speeds up the delivery process. These findings suggest that oxytocin is a valuable tool for effectively managing labor complications. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for first-time pregnant women who are at least 37 weeks along, either going into labor on their own or being induced. It's not for those already fully dilated without oxytocin, have had children before, are expecting multiples, or whose babies have significant health issues.

Inclusion Criteria

Admission for induction of labor or spontaneous labor

Nulliparous pregnant women >/= 37 weeks gestation

You are pregnant with one baby.

Exclusion Criteria

I am not on oxytocin when my cervix is fully dilated.

Your baby's head is visible at the opening of the birth canal when the cervix is fully dilated.

You are pregnant and your baby has major health problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

First Stage of Labor

Oxytocin is administered to increase uterine contractility and cause cervical dilation

Varies

Second Stage of Labor

Randomized controlled trial investigating the utility of oxytocin administration

During admission for delivery

Follow-up

Participants are monitored for postpartum outcomes such as endometritis, neonatal morbidity, and perineal laceration

During admission for delivery

What Are the Treatments Tested in This Trial?

Interventions

• Discontinue Oxytocin
• Oxytocin
• Placebo

Trial Overview The study randomly assigns participants to either continue using oxytocin during the second stage of labor or stop it altogether. The goal is to see how stopping or continuing oxytocin affects labor complications.

How Is the Trial Designed?

Group I: Discontinue Oxytocin Experimental Treatment 1 Intervention

Group II: Continue Oxytocin Active Control 1 Intervention

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?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

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]

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]

Uterine atony is the leading cause of postpartum hemorrhage, which poses significant risks to maternal health, and while risk factors exist, many cases occur without identifiable risks, making prediction challenging.

Oxytocin is the first-line treatment for uterine atony, with a low dose of 1 IU effective for elective cesarean deliveries, while higher doses are recommended for intrapartum cesarean deliveries; alternative second-line treatments include ergot alkaloids and prostaglandins, chosen based on their side effects and patient health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refractory uterine atony: still a problem after all these years. Balki, M., Wong, CA.[2021]

A systematic review of 26 trials and 5 systematic reviews found that the most common primary outcomes for measuring the effectiveness of oxytocin in treating delays in labor were caesarean section rates, length of labor, and uterine activity, indicating a focus on clinical interventions rather than patient-centered outcomes.

The study highlighted a lack of positive health-focused outcomes in the trials, suggesting that future research should incorporate more women-centered measures to improve the overall childbirth experience and promote better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome measures in studies on the use of oxytocin for the treatment of delay in labour: a systematic review. Begley, CM., Gross, MM., Dencker, A., et al.[2018]

In a study of 284 patients, using a 12-hour regimen of sustained-release dinoprostone for cervical ripening resulted in a higher need for artificial rupture of membranes and oxytocin induction compared to a 24-hour regimen (49.3% vs 38%, P = 0.03).

Despite the differences in induction methods, both regimens showed similar outcomes in terms of active labor duration, cesarean section rates, and neonatal health, indicating that dinoprostone can effectively induce labor without increasing obstetrical risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of prolonged dinoprostone cervical ripening on the rate of artificial induction of labor: a prospective study of 330 patients. Denoual-Ziad, C., Aicardi-Nicolas, S., Creveuil, C., et al.[2016]

Carbetocin is likely as effective as oxytocin and syntometrine in preventing postpartum hemorrhage, based on a review of various studies that assessed multiple outcome measures.

The safety profile of carbetocin is similar to that of oxytocin, which is currently the standard treatment for this condition, although further research is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbetocin for the prevention of postpartum hemorrhage: a systematic review. Peters, NC., Duvekot, JJ.[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]

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]

Citations

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Oxytocin - StatPearls - NCBI Bookshelf - NIH High dosages of oxytocin can cause uterine rupture, hypertonicity, and spasms. When oxytocin is given to women in the first or second stages of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12355890/

Association between total oxytocin dose and maternal and ... They conclude that high cumulative oxytocin dose had increased risks for PPH (> 1000 ml), bladder overdistension, and a negative birth ...

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The Effectiveness of Oxytocin for Preventing Postpartum ... Analysis of trustworthy data confirms that oxytocin significantly reduces the risk of PPH and severe PPH compared to no intervention and is ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933325000916

High- vs low-dose oxytocin protocols for labor induction: a ... Induction with high-dose oxytocin was associated with a lower frequency of postpartum hemorrhage, compared with a low-dose protocol (7.6% vs 9.9%, RR 0.78, 95% ...

5. ajog.org ajog.org/article/S0002-9378(23)00439-8/fulltext

Oxytocin: physiology, pharmacology, and clinical ... They found that active labor management with the early use of oxytocin reduced the length of labor by approximately 2 hours (−2.20 hours; 95% CI ...

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

Cumulative oxytocin dose in spontaneous labour High cumulative oxytocin dose in labour increases adverse postpartum outcomes. · High cumulative oxytocin dose almost tripled cases of severe bleedings ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7435109/

The Use of Oxytocin by Healthcare Professionals During ... While stimulating labor, the use of oxytocin could lead to contraindications associated with uterine, maternal, and fetal causes.

8. ajogmfm.org ajogmfm.org/article/S2589-9333(25)00046-1/fulltext

Oxytocin regimen used for induction of labor and ... Among nulliparous women, oxytocin <20 mU/min can significantly increase the risk for PPH when labor exceeds 4.5 hours.