Oxytocin Rest for Prolonged Labor

(ORCA Trial)

Overseen By Teresa C Logue

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Christiana Care Health Services

Must be taking: Oxytocin

Disqualifiers: Intraamniotic infection, Eclampsia, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: From randomization to delivery

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether taking a break from oxytocin, a common drug used to assist women in labor, can reduce the likelihood of a cesarean delivery in cases of prolonged labor. Typically, oxytocin is administered continuously, but the trial investigates if a 60-minute pause might enhance contractions and allow labor to progress more naturally. Women who are at least 36 weeks pregnant, have a single baby in the head-down position, and have been in labor for several hours under specific criteria may qualify for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve labor outcomes for many women.

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 focuses on the use of oxytocin during labor, so it's best to discuss your specific medications with the trial team.

What prior data suggests that the oxytocin rest protocol is safe for prolonged labor?

Research has shown that oxytocin, a medication used to assist with prolonged labor, is usually well-tolerated. Studies have found that stopping and then restarting oxytocin can reduce the likelihood of needing a cesarean delivery compared to continuous use. This suggests that taking a break from oxytocin might be a safe and effective strategy for managing long labor.

While specific information on side effects from taking a break with oxytocin is lacking, the drug itself is commonly used during childbirth and is known to be safe. However, because detailed research on the "oxytocin rest" method is limited, participants should feel comfortable asking questions and discussing any potential risks with their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Oxytocin Rest for prolonged labor because it explores a unique approach to managing labor differently from the usual continuous oxytocin infusion. While standard care involves a constant administration of oxytocin to help stimulate contractions, this method introduces a 60-minute rest period, potentially allowing the uterus to respond more effectively once oxytocin is resumed. This trial could offer insights into optimizing labor progression and reducing stress on both the mother and baby, making it a promising area of exploration for improving childbirth outcomes.

What evidence suggests that oxytocin rest could be effective for prolonged labor?

Research has shown that using oxytocin during labor can increase the chances of a natural vaginal birth. Studies have found that starting oxytocin early can improve the likelihood of a vaginal delivery by about 9%. In this trial, one group of participants will undergo a "60-minute oxytocin rest," which involves pausing the oxytocin drip temporarily before restarting it. This approach may help with prolonged labors. Evidence suggests that longer breaks from oxytocin might reduce the need for a cesarean section (C-section). However, strong, randomized data to fully support these ideas is not yet available. Another group in this trial will receive usual care with continuous oxytocin infusion. ^{1 6 7 8 9}

Who Is on the Research Team?

Matthew Hoffman, MD

Principal Investigator

Christiana Care Health Services

Teresa C Logue

Principal Investigator

Christiana Care Health Services

Are You a Good Fit for This Trial?

This trial is for individuals experiencing prolonged labor or difficult childbirth, specifically when induction methods have failed. To participate, they must have been receiving continuous oxytocin without seeing progress in their labor.

Inclusion Criteria

Singleton gestation in vertex presentation

≥36 weeks gestation

My labor was slow, with less than 6cm dilation after 8 hours of my water breaking and being on oxytocin.

Exclusion Criteria

Not meeting the above criteria

Cesarean section anticipated by the clinical team at time of randomization (for any reason excepting labor dystocia)

I cannot receive oxytocin due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either 60-minute oxytocin rest or continuous oxytocin infusion to manage prolonged labor

From randomization to delivery

Continuous monitoring during labor

Follow-up

Participants are monitored for maternal and neonatal outcomes until hospital discharge

Up to 28 days for neonates, average of 3 days for mothers

What Are the Treatments Tested in This Trial?

Interventions

• Oxytocin

Trial Overview The study tests 'oxytocin rest,' which means stopping and then restarting oxytocin infusion after an hour to see if it reduces the need for cesarean delivery by improving uterine contractions and labor progress.

How Is the Trial Designed?

Group I: 60-minute oxytocin rest Experimental Treatment 1 Intervention

Group II: Usual care with continuous oxytocin infusion 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?

Christiana Care Health Services

Lead Sponsor

Trials

118

Recruited

204,000+

Published Research Related to This Trial

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]

Heat-stable carbetocin is a promising alternative to oxytocin for preventing post-partum hemorrhage (PPH) in low-resource settings, as it does not require cold storage, addressing a major logistical challenge with oxytocin.

While carbetocin has a favorable side effect profile and potential additional benefits compared to oxytocin, its higher cost (20 times more) currently limits its use, although efforts are underway to make it more accessible in low- and middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbetocin: Worth the extra expense? Gallos, ID., Coomarasamy, A.[2020]

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]

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]

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]

In a study of 2499 women undergoing cesarean sections, carbetocin significantly reduced moderate blood loss (>500 mL) and the need for additional uterotonics by 20% compared to oxytocin.

While carbetocin did not significantly lower the incidence of postpartum hemorrhage (≥1000 mL), it still provided a cost-effective option, resulting in a $63.46 reduction in costs per patient despite higher drug costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and financial evaluation of carbetocin as postpartum haemorrhage prophylaxis at caesarean section: A retrospective cohort study. Wohling, J., Edge, N., Pena-Leal, D., et al.[2020]

In a study of 490 women undergoing Cesarean delivery after oxytocin-augmented labor, a longer recovery interval from oxytocin infusion was linked to reduced estimated blood loss, suggesting that allowing time for oxytocin receptor recovery can improve outcomes.

Morbidly obese women experienced significantly higher blood loss compared to those with a lower body mass index, highlighting the need for careful management of oxytocin use and monitoring in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between the time from oxytocin cessation during labour to Cesarean delivery and postpartum blood loss: a retrospective cohort study. Tran, G., Kanczuk, M., Balki, M.[2018]

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. trialx.com trialx.com/clinical-trials/listings/317750/oxytocin-rest-to-reduce-cesarean-delivery/

Oxytocin Rest to Reduce Cesarean Delivery The purpose of this study is to assess whether oxytocin rest of 60 minutes in patients with prolonged labor reduces risk for cesarean delivery. Description.

2. acog.org acog.org/clinical/clinical-guidance/clinical-practice-guideline/articles/2024/01/first-and-second-stage-labor-management

First and Second Stage Labor Management Early oxytocin was associated with a modest increase in the probability of spontaneous vaginal delivery (RR 1.09; 95% CI, 1.03–1.17). The meta-analysis ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32028487/

Association of Oxytocin Rest During Labor Induction ... Conclusion: An oxytocin rest of at least 8 hours is a clinical tool that may reduce the risk of cesarean delivery among women with protracted latent labor ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/31/NCT06268431/Prot_SAP_000.pdf

01/21/2024 Page 1 of 7 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 ... There is no randomized or prospective data to support oxytocin rest. ... • Composite maternal adverse outcomes (CAMO):. 53 o Operative ...

5. journals.lww.com journals.lww.com/mcnjournal/fulltext/2020/07000/considerations_for_active_labor_management_with.13.aspx

Considerations for Active Labor Management with Oxytocin:... Recent evidence suggests an oxytocin “rest” or discontinuing oxytocin once active labor has been established may be one way to minimize labor complications.

6. withpower.com withpower.com/trial/oxytocin-rest-for-prolonged-labor-51b11

Oxytocin Rest for Prolonged Labor (ORCA Trial) 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 ...

7. trial.medpath.com trial.medpath.com/clinical-trial/d9488ba33bafcbe1/nct06268431-oxytocin-reduce-cesarean-delivery-prolonged-labor

Oxytocin Rest to Reduce Cesarean Delivery - MedPath The purpose of this study is to assess whether oxytocin rest of 60 minutes in patients with prolonged labor reduces risk for cesarean delivery. Detailed ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40113155/

Reduced risk of cesarean delivery with oxytocin ... The rate of cesarean delivery, reported in 13 studies, was lower with discontinuation of oxytocin in the active phase of labor (relative risk=0.80; 95% ...

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/97/NCT02487797/Prot_SAP_000.pdf

A randomized double blind clinical trial comparing oxytocin ... Our data will allow us to help establish evidence-based guidelines for the optimal use of oxytocin for labor augmentation. Furthermore, this ...