Oxytocin for Labor Complications

(ROSSoL Trial)

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

Trial Summary

What is the purpose of this trial?

This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.

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.

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

Research shows that using a checklist for administering Pitocin (a synthetic form of oxytocin) significantly reduced hospital stay duration and the presence of meconium (a sign of fetal distress) during labor, indicating its effectiveness when used correctly. ^{1 2 3 4 5}

Is oxytocin safe for use in labor complications?

Oxytocin, including its synthetic forms like Syntocinon and Pitocin, is generally considered safe for use in labor when administered correctly and under supervision. However, misuse can lead to serious problems for both the mother and fetus, so careful monitoring and dosage adjustment are important. ^{1 2 3 6 7}

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

Oxytocin, often used as Pitocin or Syntocinon, is unique because it is a synthetic form of a natural hormone that helps induce or augment labor by stimulating uterine contractions. Unlike other uterotonic agents like ergot alkaloids or prostaglandins, oxytocin is typically the first-line treatment for preventing and treating uterine atony (lack of muscle tone in the uterus) and is administered intravenously, allowing for precise control of dosage and effects. ^{1 2 3 7 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

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

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

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

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

Synthetic oxytocin. [2018]

4. Scotland pubmed.ncbi.nlm.nih.gov

Outcome measures in studies on the use of oxytocin for the treatment of delay in labour: a systematic review. [2018]

5. Australia 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. [2016]

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

Carbetocin for the prevention of postpartum hemorrhage: a systematic review. [2018]

7. England pubmed.ncbi.nlm.nih.gov

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

Refractory uterine atony: still a problem after all these years. [2021]