Oxytocin for Labor Complications
(ROSSoL Trial)
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Washington University School of Medicine
Must be taking: Oxytocin
Disqualifiers: Multiple gestations, Multiparous, Major fetal anomalies, others
No Placebo Group
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.
12345Is 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.
12367How 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.
12378Eligibility 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.
+2 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Discontinue OxytocinExperimental Treatment1 Intervention
Group II: Continue OxytocinActive 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:
Barnes Jewish HospitalSaint Louis, MO
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Who Is Running the Clinical Trial?
Washington University School of MedicineLead Sponsor
University of MichiganCollaborator
References
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
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.
Outcome measures in studies on the use of oxytocin for the treatment of delay in labour: a systematic review. [2018]to identify primary and secondary outcome measures in randomised trials, and systematic reviews of randomised trials, measuring effectiveness of oxytocin for treatment of delay in the first and second stages of labour, and to identify any positive health-focussed outcomes used.
Impact of prolonged dinoprostone cervical ripening on the rate of artificial induction of labor: a prospective study of 330 patients. [2016]The aim of this study was to evaluate two regimens of administration of sustained-release dinoprostone on the need for oxytocin induction of labor.
Carbetocin for the prevention of postpartum hemorrhage: a systematic review. [2018]The objective of this review was to evaluate the efficacy and safety of carbetocin in the prevention of postpartum hemorrhage. All trials found during a targeted Medline and Cochrane database search were screened for eligibility. Outcome measures were estimated blood loss, uterine tone, amount and type of lochia, fundal position after delivery (number of centimeters above or below the umbilicus), side-effects, adverse effects, vital signs, levels of hemoglobin/hematocrit before delivery compared with 24 or 48 hours postpartum, the need for additional uterotonic therapy, and/or uterine massage and duration of the third stage of labor. The retrieved studies were difficult to compare because of differences in study design and outcome. We conclude that carbetocin probably is as effective as oxytocin or syntometrine in the prophylactic management of the third stage of labor. Also carbetocin has a similar safety profile to oxytocin, which is now used as a standard prophylactic treatment. However, more research on this subject is needed.
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.
Refractory uterine atony: still a problem after all these years. [2021]Postpartum hemorrhage is a leading cause of maternal morbidity and mortality, and uterine atony is the leading cause of postpartum hemorrhage. Risk factors for uterine atony include induced or augmented labor, preeclampsia, chorio-amnionitis, obesity, multiple gestation, polyhydramnios, and prolonged second stage of labor. Although a risk assessment is recommended for all parturients, many women with uterine atony do not have risk factors, making uterine atony difficult to predict. Oxytocin is the first-line drug for prevention and treatment of uterine atony. It is a routine component of the active management of the third stage of labor. An oxytocin bolus dose as low as 1 IU is sufficient to produce satisfactory uterine tone in almost all women undergoing elective cesarean delivery. However, a higher bolus dose (3 IU) or infusion rate is recommended for women undergoing intrapartum cesarean delivery. Carbetocin, available in many countries, is a synthetic oxytocin analog with a longer duration than oxytocin that allows bolus administration without an infusion. Second line uterotonic agents include ergot alkaloids (ergometrine and methylergonovine) and the prostaglandins, carboprost and misoprostol. These drugs work by a different mechanism to oxytocin and should be administered early for uterine atony refractory to oxytocin. Rigorous studies are lacking, but methylergonovine and carboprost are likely superior to misoprostol. Currently, the choice of second-line agent should be based on their adverse effect profile and patient comorbidities. Surgical and radiologic management of uterine atony includes uterine tamponade using balloon catheters and compression sutures, and percutaneous transcatheter arterial embolization.