Pitocin (Oxytocin) - Summary

PITOCIN SUMMARY

Pitocin (oxytocin injection, USP) is a sterile, clear, colorless aqueous solution of synthetic oxytocin, for intravenous infusion or intramuscular injection. Pitocin is a nonapeptide found in pituitary extracts from mammals. It is standardized to contain 10 units of oxytocic hormone/mL and contains 0.5% Chlorobutanol, a chloroform derivative as a preservative, with the pH adjusted with acetic acid. Pitocin may contain up to 16% of total impurities. The hormone is prepared synthetically to avoid possible contamination with vasopressin (ADH) and other small polypeptides with biologic activity.

IMPORTANT NOTICE

Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor.

Antepartum: Pitocin is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, preeclampsia at or near term, when delivery is in the best interests of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) as adjunctive therapy in the management of incomplete or inevitable abortion. In the first trimester, curettage is generally considered primary therapy. In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases.

Postpartum: Pitocin is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.

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NEWS HIGHLIGHTS

Media Articles Related to Pitocin (Oxytocin)

Study Links Genetic Variation To Individual Empathy, Stress Levels
Source: Anxiety / Stress News From Medical News Today [2009.11.17]
Researchers have discovered a genetic variation that may contribute to how empathetic a human is, and how that person reacts to stress. In the first study of its kind, a variation in the hormone/neurotransmitter oxytocin's receptor was linked to a person's ability to infer the mental state of others. Interestingly, this same genetic variation also related to stress reactivity.

The 'Love Hormone,' Also Affects Antisocial Behaviors, Such As Envy And Gloating
Source: Endocrinology News From Medical News Today [2009.11.14]
A new study carried out at the University of Haifa has found that the hormone oxytocin, the "love hormone", which affects behaviors such as trust, empathy and generosity, also affects opposite behaviors, such as jealousy and gloating.

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Published Studies Related to Pitocin (Oxytocin)

Study protocol. ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section. [2009.08.24]
BACKGROUND: Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%...

Haemodynamic effects of repeated doses of oxytocin during Caesarean delivery in healthy parturients. [2009.08]
BACKGROUND: The haemodynamic effects of oxytocin 5 u have been described previously, but still some authors attribute these effects to the delivery itself. We studied the haemodynamic effects of two repeated doses of oxytocin i.v. in 20 healthy women during spinal anaesthesia for Caesarean delivery... CONCLUSIONS: An initial bolus of oxytocin 5 u produced prominent haemodynamic changes, whereas a second bolus produced smaller changes. This could be due to desensitization of endothelial oxytocin receptors.

A randomized controlled trial of intranasal oxytocin as an adjunct to exposure therapy for social anxiety disorder. [2009.07]
In humans, oxytocin nasal administration reduces social-threat perception and improves processes involved in communication and the encoding of positive social cues. The aim of this study was to determine whether oxytocin given as an adjunct to exposure therapy improves treatment for social anxiety disorder (SAD) as indicated by a comprehensive set of symptom outcome measures...

Randomized trial of oxytocin antagonist atosiban versus beta-adrenergic agonists in the treatment of spontaneous preterm labor in Taiwanese women. [2009.06]
BACKGROUND/PURPOSE: Management of preterm labor involves the use of tocolytic drugs to inhibit preterm uterine contractions. This study compared the efficacy and safety of intravenous administration of atosiban and ritodrine in the treatment of spontaneous preterm labor... CONCLUSION: The present study showed similar effectiveness between atosiban and ritodrine, while tachycardia occurred more frequently in women treated with ritodrine. These results indicate that atosiban is an effective tocolytic drug without the conventional cardiovascular side effects often seen with beta-agonist treatment.

The effect of barusiban, a selective oxytocin antagonist, in threatened preterm labor at late gestational age: a randomized, double-blind, placebo-controlled trial. [2009.06]
OBJECTIVE: The objective of the study was to compare barusiban with placebo in threatened preterm labor... CONCLUSION: An intravenous bolus of barusiban was no more effective than placebo in stopping preterm labor in pregnant women at late gestational age.

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Clinical Trials Related to Pitocin (Oxytocin)

Oxytocin Administration in the Third Stage of Labour - A Study of Appropriate Route and Dose [Completed]
Mothers are given the medication oxytocin after birth to help the uterus (womb) contract and therefore reduce blood loss. In Canada, oxytocin is given either into the muscle of the thigh or into a vein. However, it is not known which route is better. This study will test which dose and route of oxytocin is best in reducing blood loss following vaginal delivery.

Ergot and Oxytocin During Cesarean Delivery Following Failure to Progress in Labour [Completed]
Despite of marked improvements in clinical management, early postpartum hemorrhage(PPH)remains a significant contributor to maternal morbidity and mortality both in developing countries and in hospitals equipped with all that modern medicine has to offer. This complication is amongst the most challenging that a clinician will face in the obstetric patient. Prevention, early recognition and prompt appropriate intervention are the keys to minimizing the impact of PPH on women’s health.

Patients undergoing Cesarean sections following failure to progress in labor are at great risk for PPH and should theoretically benefit from an additional uterotonic agent. This study will be conducted to define whether the addition of ergonovine maleate to oxytocin, administered in a prophylactic way, reduces blood loss during Cesarean section for failure to progress in labor.

The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes [Recruiting]
Fetal heart rate patterns are an important parameter in the diagnosis of non-reassuring fetal status. Combined-spinal epidural analgesia is a method of initiating labor analgesia used by approximately 90% of the parturients at Prentice Women's Hospital. Optimizing the variables which could affect fetal heart rate patterns at the time of initiation of analgesia, such as fluid administration and oxytocin management, could help us provide better care for our patients and their fetuses.

Hypotheses: Patients who receive a 1000 mL fluid bolus and lower rates of oxytocin administration will have fewer non-reassuring FHR changes.

Induction of Labor With Oxytocin: When Should Oxytocin be Held? [Recruiting]
The investigators propose to perform a prospective randomized control trial to compare the rate of cesarean delivery in women where Oxytocin (OT) is discontinued once active labor begins (5 cm dilation) when compared with women where OT is continued at a maintenance level per the usual protocol.

One study group will follow an oxytocin protocol which is incremental until 5 cm dilation and then maintained at the same level throughout labor. The second arm will follow an oxytocin protocol also incremental, but then discontinued once the cervix is 5 cm. The primary outcome will be the rate of cesarean delivery between the groups. Secondary outcomes to be evaluated will include duration of the labor, fetal heart rate abnormalities, and frequency of uterine hyperstimulation, maternal and neonatal outcomes.

As mentioned in the study proposal, the proposed experimental arm is currently not performed as part of the oxytocin guidelines at the investigators' institution. One study from Israel suggests no difference in pregnancy outcomes with the proposed use of oxytocin. Although some providers stop the oxytocin in active labor for their patients, this is not a commonly performed procedure at the investigators' institution. The investigators are not aware of other institutions employing the above practice.

Adjuvant Oxytocin for Preinduction Ripening With a Foley Catheter--a Clinical Trial [Completed]
The transcervical Foley catheter (TFC) is a proven and effective mode of cervical ripening. It is common practice to use TFC with simultaneous low-dose oxytocin under the assumption that the combination results in a more successful labor induction. Scientific validation of this practice is lacking. We seek to determine if the addition of oxytocin to TFC improves induction success.

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