SYNTOCINON SUMMARY
Syntocinon®
Syntocinon® (oxytocin) is a synthetic, (1-6) cyclic nonapeptide.
Important Notice
| Syntocinon® (oxytocin) injection is indicated for the medical rather than the elective induction of labor. Available data and information are inadequate to define the benefits to risk considerations in the use of the drug product for elective induction. Elective induction of labor is defined as the initiation of labor for convenience in an individual with a term pregnancy who is free of medical indications. |
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Antepartum
Syntocinon® (oxytocin) is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable, in order to achieve early vaginal delivery for fetal or maternal reasons. 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, pre-eclampsia at or near term, when delivery is in the best interest 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 the 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
Syntocinon® (oxytocin) injection 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 Syntocinon (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.
Clinical Trials Related to Syntocinon (Oxytocin)
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.
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.
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.
Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India [Not yet recruiting]
This cluster randomized community-based trial is designed to test the hypothesis that the
intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of
labor by an Auxiliary Nurse Midwife (ANM) at births occurring in homes, Sub-Centers and
Primary Health Centers in Bagalkot, India will reduce the risk of postpartum hemorrhage by
44% (from 9% to 5%) relative to home births attended by the same type of provider who does
not provide the intervention drug. The study will also document correct use of oxytocin in
Uniject, adverse maternal and fetal events associated with inappropriate use and a number of
indicators reflecting the programmatic feasibility of implementing this intervention.
Reports of Suspected Syntocinon (Oxytocin) Side Effects
Postpartum Haemorrhage (9),
Maternal Exposure During Pregnancy (4),
Agitation (2),
Akathisia (2),
Rhabdomyolysis (2),
Hyperpyrexia (2),
Chills (2),
Pyrexia (2),
Pallor (2),
Hallucination (2), more >>
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