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

Published Studies Related to Pitocin (Oxytocin)

Adjunctive intranasal oxytocin improves verbal memory in people with schizophrenia. [2012]
CONCLUSIONS: This is the first report we are aware of documenting a beneficial

Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial. [2012]
among women who delivered vaginally... CONCLUSION: Compared with 10 units, 80 units or 40 units of prophylactic oxytocin

Carbetocin versus oxytocin for prevention of postpartum hemorrhage in patients with severe preeclampsia: a double-blind randomized controlled trial. [2011.11]
Objective: In patients with severe preeclampsia there is an increased risk of postpartum hemorrhage, but the hemodynamic changes associated with severe preeclampsia make the management of any kind of bleeding particularly troublesome... Considering that it appears not to have a major hemodynamic effect in women with severe preeclampsia and that it uses a lower volume per dose than oxytocin, it should be considered a valid option in the management of the third stage of labour in women with hypertensive disorders of pregnancy.

Intranasal oxytocin reduces psychotic symptoms and improves Theory of Mind and social perception in schizophrenia. [2011.10]
Oxytocin has numerous prosocial and antipsychotic-like effects in animals.

Haemodynamic effects of carbetocin and oxytocin given as intravenous bolus on women undergoing caesarean delivery: a randomised trial. [2011.10]
OBJECTIVE: This study compares the maternal heart rate effects of carbetocin and oxytocin during elective caesarean delivery. DESIGN: Double blind randomised single centre study (1:1). SETTING: University hospital providing intrapartum care. POPULATION: Fifty-six women undergoing elective caesarean section after spinal anaesthesia... CONCLUSION: Both oxytocins have comparable haemodynamic effects and are uterotonic drugs with an acceptable safety profile for prophylactic use. Minimal differences in the recovery phase beyond 70 seconds are in keeping with the fact that carbetocin has an extended half-life compared with oxytocin. (c) 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology (c) 2011 RCOG.

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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.

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.

Oxytocin Treatment of Schizophrenia [Recruiting]
Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, improves social cognition, social functioning and decreases paranoia and other psychotic symptoms in schizophrenia.

Participants: 80 adults with schizophrenia for at least one year and with a high rating for paranoia.

Procedures (methods): Oxytocin or placebo will be administered twice daily in an intranasal spray (6 insufflations/dose or 24 IU) for 6 weeks. Before, during and at the end of the trial, each subject will undergo psychiatric symptom ratings and tests of mental abilities used in social functioning and social competence and subjects and an informant will complete ratings of social functioning.

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.

Effect of Prophylactic Administration of Oxytocin in Uniject™ on Postpartum Hemorrhage at Home Births in Ghana [Not yet recruiting]
This study is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by a Community Health Officer (CHO) at home births in Ghana will reduce the risk of postpartum hemorrhage by 50 percent relative to home births attended by the same type of provider who does not provide a uterotonic drug.

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Reports of Suspected Pitocin (Oxytocin) Side Effects

Drug Ineffective (2),  Postpartum Haemorrhage (2),  Unresponsive TO Stimuli (1),  Foetal Growth Restriction (1),  Hyperventilation (1),  Feeling Hot (1),  Foetal Heart Rate Decreased (1),  Blood Magnesium Increased (1),  Procedural Pain (1),  Product Quality Issue (1), more >>