Oxytocin Rest for Prolonged Labor
(ORCA Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Christiana Care Health Services
Must be taking: Oxytocin
Disqualifiers: Intraamniotic infection, Eclampsia, others
No Placebo Group
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?Prolonged labor is usually managed with continuous oxytocin infusion. "Oxytocin rest" has been proposed as a strategy to resolve protracted labor in patients who have received continuous oxytocin without progress. This strategy involves discontinuing oxytocin then restarting infusion after a period of time, under the theory that washout of the oxytocin receptor will strengthen uterine contractions to improve labor progress. "Oxytocin rest" is performed on labor and delivery units across the United States. Yet, there is no randomized or prospective data to support the practice.
The purpose of this study is to assess whether oxytocin rest of 60 minutes in patients with prolonged labor reduces risk for cesarean delivery.
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 data supports the effectiveness of the drug oxytocin for prolonged labor?
Research shows that synthetic oxytocin, like Pitocin, is commonly used in labor management and is considered as effective as natural oxytocin. However, its use requires careful supervision to avoid potential side effects, and there is no consensus on the optimal dose.
12345Is oxytocin safe for use in humans?
Oxytocin, including its synthetic forms like Syntocinon and Pitocin, has been used safely in many patients for labor-related purposes without observed side effects in some studies. However, misuse can lead to serious problems, so it should be used with proper supervision and dosage adjustment.
12456How does the drug oxytocin differ from other treatments for prolonged labor?
Oxytocin is unique because it is a commonly used drug to help manage labor by stimulating uterine contractions, but its use requires careful supervision and dosage adjustment to avoid potential risks. Unlike some alternatives, oxytocin needs cold storage, which can be a challenge in low-resource settings.
12789Eligibility Criteria
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
I am 18 years old or older.
+1 more
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.
+5 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: 60-minute oxytocin restExperimental Treatment1 Intervention
Group II: Usual care with continuous oxytocin infusionActive Control1 Intervention
Oxytocin is already approved in United States, European Union, Canada, Australia 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
🇦🇺 Approved in Australia as Oxytocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
ChristianaCare Health SystemNewark, DE
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Who Is Running the Clinical Trial?
Christiana Care Health ServicesLead Sponsor
References
Variations in oxytocin regimes in Scottish labour wards in 1998. [2004]Oxytocin (Syntocinon, Sandoz Pharmaceuticals) is a commonly used drug in the modern management of labour. A recently published British survey found that 38% of low risk primigravid labours were augmented, most commonly by intravenous syntocinon. Unfortunately the misuse of syntocinon can lead to potentially serious problems for the fetus and mother. Despite the frequency of usage there appears to be no consensus as to the optimal dose and mode of administration. This paper explores the extent of this variation among Scottish obstetric units, the reasons for any variation in its use and makes some suggestions as to the way forward based on the current literature.
Synthetic oxytocin. [2018]A synthetic oxytocin, Syntocinon(R), was used in 3,342 obstetrical patients for a wide variety of indications. It was concluded that the preparation is as effective as natural oxytocin.(1) There were no side effects observed, particularly vasospasm or anaphylactic reaction. Its use in clinical obstetrics can be recommended provided there is a proper indication for its use and the need for close supervision and individual adjustment of dosage is recognized.
Ambulation versus oxytocin in protracted labour: a pilot study. [2019]We compared ambulation with oxytocin in the treatment of protracted labour with a randomized, controlled trial of 57 patients. Sixty percent of the women in the ambulant group delivered their babies without oxytocin. In the ambulant group, the mean length of the second stage of labour was shorter and the women themselves held relatively positive views on their experiences. In the oxytocin group, on the other hand, the women experienced stronger contractions before pushing and also suffered from more excessively strong contractions. Our trial included too few women to judge which treatment is better for the infant's health. Nevertheless, the women's opinions and the quality of their contractions demonstrate that more attention should be paid to ambulation as a treatment for protracted labour.
Outcomes of the Evidence-Based Pitocin Administration Checklist at a Tertiary-Level Hospital. [2018]Pitocin, a synthetic form of the hormone oxytocin, is a high-alert medication that heightens patient harm when used incorrectly. This investigation examined the outcomes of an evidence-based Pitocin administration checklist used for labor augmentation at a tertiary-level hospital. Data came from patient records. Using the Perinatal Trigger Tool, N = 372 clinical records (n = 194 prior to and n = 178 following checklist implementation) were reviewed. Checklist implementation resulted in statistically significant reductions in the duration of hospitalization (1.72 vs. 2.02 days, p = .0005), presence of meconium (23.7% vs. 6.7%, p
A randomised trial of carbetocin versus syntometrine in the management of the third stage of labour. [2021]Syntometrine is an effective uterotonic agent used in preventing primary postpartum haemorrhage but has adverse effects including nausea, vomiting, hypertension and coronary artery spasm. Carbetocin is a newly developed long-acting oxytocin analogue that might be used as an uterotonic agent. We compare the efficacy and safety of intramuscular (IM) carbetocin with IM syntometrine in preventing primary postpartum haemorrhage.
Induction of labour by simultaneous intravenous administration of prostaglandin E 2 and oxytocin. [2019]In a group of 20 matched primigravid patients labour was induced by forewater amniotomy followed by intravenous oxytocin (Syntocinon) administered in escalating doses. Ten of these patients, in a double-blind trial, also received prostaglandin E(2) infused simultaneously with the oxytocin. In the combined prostaglandin-oxytocin group there was a noticeable reduction in the dosage of oxytocin required to produce effective uterine action, and the duration of labour was also reduced. No side effects were observed.
Clinical and financial evaluation of carbetocin as postpartum haemorrhage prophylaxis at caesarean section: A retrospective cohort study. [2020]The long-acting oxytocic agent; carbetocin, has been consistently shown to reduce the need for additional uterotonics at caesarean section, but not postpartum haemorrhage (PPH). While promising, current evidence is limited by heterogenicity in study design and findings.
Carbetocin: Worth the extra expense? [2020]Every six minutes, a mother dies from post-partum haemorrhage (PPH) in low- and middle-income countries, often in the prime of her life and often leaving behind a young family. To prevent PPH, the routine administration of a uterus-contracting ('uterotonic') agent is a standard practice across the world. Oxytocin is the standard uterotonic agent recommended for this purpose, and is recommended for all women giving birth. Oxytocin is problematic as it requires cold storage and transport, and in low-resource settings, the cold chain is not commonly available. Hence, using heat-stable carbetocin in these settings can be advantageous. Heat-stable carbetocin is a promising alternative to oxytocin. Because of its heat stability, it can overcome the persistent problems with oxytocin quality as it does not require cold chain for storage and transport. Considering the totality of the evidence, it appears to have some additional desirable effects compared with oxytocin and a very favourable side effect profile similar to oxytocin. However, because carbetocin costs 20 times more than oxytocin and is not widely available yet, oxytocin remains the mainstay for prevention of PPH. However, this may change as WHO has signed a memorandum of understanding with the manufacturer to provide carbetocin for the public sector of LMIC at a similar price level to that of oxytocin. Currently, carbetocin is being registered in 90 low- and middle-income countries to be made available and improve access to this life-saving uterotonic agent.
The association between the time from oxytocin cessation during labour to Cesarean delivery and postpartum blood loss: a retrospective cohort study. [2018]Prolonged exposure to oxytocin during augmentation of labour is associated with uterine atony and an increased risk of postpartum hemorrhage (PPH) due to oxytocin receptor desensitization. Cessation of oxytocin infusion during labour may facilitate recovery of oxytocin receptor function, which then helps to restore myometrial contractility and decrease postpartum blood loss. We examined the association between oxytocin recovery interval, i.e., the time from discontinuing oxytocin to Cesarean delivery (CD) for labour arrest, and blood loss.