Oxytocin Dosing for Prolonged Labor
Recruiting in Palo Alto (17 mi)
AW
Overseen byAmanda Wang, MD
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: The University of Texas Medical Branch, Galveston
No Placebo Group
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
The goal of this clinical trial is to compare oxytocin infusion rates for induction and augmentation of labor in nulliparous women. The main question\[s\] it aims to answer are: * Does a high dose oxytocin infusion protocol affect length of induction to delivery interval? * Does a high dose oxytocin infusion protocol affect mode of delivery? * Does a high dose oxytocin infusion protocol affect maternal and neonatal outcomes? Participants will be randomized to either low- or high-dose oxytocin groups: * The low dose group will receive an infusion to start at 2 milli-units/min and will be increased by 2 milli-units/min every 20 minutes. The maximum rate of infusion is 40 milli-units/min. * The high dose group will receive an infusion to start at 6 milli-units/min and will be increased by 6 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that Oxytocin Dosing for Prolonged Labor is an effective drug?
The available research shows that synthetic oxytocin, like Syntocinon, is effective in managing labor. One study found it to be as effective as natural oxytocin without any observed side effects, making it a recommended option when used correctly. Another study suggests that using oxytocin in a pulsatile manner can reduce the risk of negative effects for both mother and baby. However, a comparison with ambulation (walking around) showed that many women preferred ambulation due to less intense contractions, indicating that while oxytocin is effective, other methods might offer a more comfortable experience for some women.12345
What safety data exists for oxytocin use in labor?
Oxytocin, including its synthetic forms like Syntocinon and Pitocin, has been widely studied for use in labor. Studies show that when used correctly, oxytocin is effective and generally safe, with no significant side effects like vasospasm or anaphylactic reactions observed. However, misuse can lead to serious problems for both the mother and fetus. Safety measures such as standardized protocols, checklists, and trained staff are recommended to minimize risks. High-dose regimens have been shown to be safe, with no significant differences in adverse outcomes like fetal heart rate abnormalities or postpartum hemorrhage. Overall, oxytocin is safe when administered with proper supervision and dosage adjustments.12678
Is the drug Oxytocin a promising treatment for prolonged labor?
Research Team
AW
Amanda Wang, MD
Principal Investigator
University of Texas
Eligibility Criteria
This trial is for first-time mothers aged 18-50, at least 37 weeks pregnant with one baby in the head-down position, and no prior uterine surgery. They must be presenting for labor induction or need help speeding up their labor. Women can't join if they have a non-reassuring fetal heart rate, allergy to oxytocin, certain pregnancy complications like growth restriction of the fetus, contraindications to vaginal delivery or previous cervical ripening treatments.Inclusion Criteria
I am a woman aged between 18 and 50.
I have never had surgery on my uterus.
I need medication to help with labor.
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Exclusion Criteria
Allergy to oxytocin
My pregnancy ended in loss or my baby was diagnosed with a severe condition.
I cannot have a baby through natural childbirth.
See 5 more
Treatment Details
Interventions
- Oxytocin (Hormone Therapy)
Trial OverviewThe study compares low-dose versus high-dose oxytocin protocols for inducing and accelerating labor in women giving birth for the first time. One group will receive a starting dose of oxytocin at 2 milli-units/min increased every 20 minutes up to a max of 40 milli-units/min; the other starts at 6 milli-units/min with similar increases.
Participant Groups
2Treatment groups
Active Control
Group I: High dose oxytocinActive Control1 Intervention
The high dose oxytocin group will receive a controlled infusion pump at a proximal port on the peripheral IV line. The infusion will start at 6 milli-units/min and will be increased by 6 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min. Oxytocin infusion rate is adjusted to maintain adequate uterine contractions.
Group II: Low dose oxytocinActive Control1 Intervention
The low dose oxytocin group will receive a controlled infusion pump at a proximal port on the peripheral IV line. The infusion will start at 2 milli-units/min and will be increased by 2 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min. Oxytocin infusion rate is adjusted to maintain adequate uterine contractions.
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:
University of Texas Medical BranchGalveston, TX
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Who Is Running the Clinical Trial?
The University of Texas Medical Branch, Galveston
Lead Sponsor
Trials
263
Patients Recruited
55,400+
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.
Evolving concepts of oxytocin for induction of labor. [2005]Based on findings of maternal and fetal circulating oxytocin levels during spontaneous labor and the available information on oxytocin secretion patterns, the dosage and mode of administration of oxytocin for induction of labor is discussed. It is recommended that intravenous infusion rates should not exceed 2 to 8 mU/min. Oxytocin administered in a pulsatile fashion beginning with 1 mU/min every 8 minutes with doubling the pulse dose every 24 minutes is equally as efficient as continuous infusion. Because both the peak levels and the total dose of oxytocin needed for induction are lower with pulsatile than continuous administration, the risk of adverse effects for the mother and the fetus is significantly reduced.
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.
The use of oxytocin. [2018]Synthetic oxytocin offers a safe and effective means of producing regular uterine activity and has a fairly large therapeutic index; however, the mild antidiuretic and vasoactive properties of oxytocin increase the risk of water intoxication and hypotension. The issue of reduction in cesarean section rates through the use of an active management protocol is being studied actively in the United States and Canada at this time. The authors recommend infusion protocols for the augmentation and induction of labor that use low doses of dilute oxytocin, increased at intervals no more than 40 minutes. Pharmacokinetic and clinical studies support the use of oxytocin in the physiologic range as efficacious and prudent. The longer induction to delivery time demonstrated by some, but not all authors, in our opinion, is a reasonable alternative to avoidable uterine hyperstimulation with the potential for fetal and maternal injury. We advocate the use of the lowest dose necessary to produce adequate uterine contractility and cervical change.
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
Oxytocin: physiology, pharmacology, and clinical application for labor management. [2023]Oxytocin is a peptide hormone that plays a key role in regulating the female reproductive system, including during labor and lactation. It is produced primarily in the hypothalamus and secreted by the posterior pituitary gland. Oxytocin can also be administered as a medication to initiate or augment uterine contractions. To study the effectiveness and safety of oxytocin, previous studies have randomized patients to low- and high-dose oxytocin infusion protocols either alone or as part of an active management of labor strategy along with other interventions. These randomized trials demonstrated that active management of labor and high-dose oxytocin regimens can shorten the length of labor and reduce the incidence of clinical chorioamnionitis. The safety of high-dose oxytocin regimens is also supported by no associated differences in fetal heart rate abnormalities, postpartum hemorrhage, low Apgar scores, neonatal intensive care unit admissions, and umbilical artery acidemia. Most studies reported no differences in the cesarean delivery rates with active management of labor or high-dose oxytocin regimens, thereby further validating its safety. Oxytocin does not have a predictable dose response, thus the pharmacologic effects and the amplitude and frequency of uterine contractions are used as physiological parameters for oxytocin infusion titration to achieve adequate contractions at appropriate intervals. Used in error, oxytocin can cause patient harm, highlighting the importance of precise administration using infusion pumps, institutional safety checklists, and trained nursing staff to closely monitor uterine activity and fetal heart rate changes. In this review, we summarize the physiology, pharmacology, infusion regimens, and associated risks of oxytocin.
Improving patient safety and uniformity of care by a standardized regimen for the use of oxytocin. [2009]Oxytocin is 1 of the most commonly used drugs in labor and has been associated with adverse maternal and fetal outcomes. In an attempt to improve patient safety, we constructed a standardized protocol for labor induction with oxytocin. We reviewed the numerous publications regarding oxytocin use for either induction or augmentation of labor in order to determine if there was a protocol available that would maximize success of delivery and minimize the adverse maternal and fetal effects of the drug. Using the literature review and the specific pharmacokinetics of oxytocin, we developed a standardized approach for the dilution and administration of oxytocin in order to improve patient safety, develop uniformity of the drug use, maximize its benefits, and minimize its side effects. We suggest that a standardized approach to oxytocin use be adopted that uses an oxytocin dilution of 10 mU/mL, initial dose of 2 mU/min (12 mL/hr), incremental increase of 2 mU (12 mL) every 45 minutes until adequate labor with the maximum dose being 16 mU/min (96 mL/hr).
Induction of labour by pharmacological and physiological doses of intravenous oxytocin. [2019]In addition to membrane rupture, pharmacological doses of oxytocin (2.6 mU/minute rusing stepwise to 422.4 mU/minute) were used in 134 patients and the results compared to those obtained in 144 patients given only physiological doses of oxytocin (2.6 to 13.2 mU/minute). Pharmacological doses of oxytocin gave better results in terms of induction-delivery intervals, incidence of failed inductions and puerperal morbidity. The incidence of hypertonus was similar in both groups and unrelated to oxytocin doses. A uterine activity of 276 Montevideo units, modified to 200 to 220 Montevideo units for grande multiparae, is defined as the goal of oxytocin treatment in induction of labour. A sign of imminent uterine tetany in the intrauterine pressure curve (the 'damping sign') is described.