The condition of the cervix should be assessed carefully before PROPESS is used. After insertion, uterine activity and fetal condition must be monitored regularly. PROPESS must only be used if facilities for continuous fetal and uterine monitoring are available. If there is any suggestion of maternal or fetal complications or if adverse effects occur, the pessary should be removed from the vagina.
The experience of PROPESS in patients with ruptured membranes is limited. Therefore, PROPESS should be used with caution in those patients. Since the release of dinoprostone from the pessary can be affected in the presence of amniotic fluid, special attention should be given to uterine activity and fetal condition.
PROPESS should be used with caution in patients with a previous history of uterine hypertonus, glaucoma or asthma.
Medication with non-steroidal anti-inflammatory drugs, including acetylsalicylic acid, should be stopped before administration of dinoprostone.
If uterine contractions are prolonged or excessive, there is possibility of uterine hypertonus or rupture and the pessary should be removed immediately. Uterine rupture has been reported in association with the use of PROPESS, mainly in patients with contraindicated conditions (see Contraindications). Therefore, PROPESS should not be administered to patients with a history of previous caesarean section or uterine surgery given the potential risk for uterine rupture and associated obstetrical complications.
PROPESS should be used with caution when there is a multiple pregnancy. No studies in multiple pregnancy have been performed.
PROPESS should be used with caution when the woman has had more than three full term deliveries. No studies in woman with more than three full term deliveries have been performed.
A second dose of PROPESS is not recommended, as the effects of a second dose have not been studied.
The use of the product in patients with diseases which could affect the metabolism or excretion of dinoprostone, e.g. lung, liver or renal disease, has not been specifically studied. The use of the product in such patients is not recommended.
Women aged 35 and over, women with complications during pregnancy, such as gestational diabetes, arterial hypertension and hypothyroidism, and women at gestational age above 40 weeks have a higher post‑partum risk for developing disseminated intravascular coagulation (DIC). These factors may additionally enhance the risk of disseminated intravascular coagulation in women with pharmacologically induced labour (see Adverse Reactions). Therefore, dinoprostone and oxytocin should be used with caution in these women. In the immediate post‑partum phase the physician should look out carefully for early signs of a developing DIC (e.g. fibrinolysis).
The Clinician should be alert that, as with other labour induction methods, use of dinoprostone may result in inadvertent abruption of placenta and subsequent embolization of antigenic tissue causing in rare circumstances the development of Anaphylactoid Syndrome of Pregnancy (Amniotic Fluid Embolism).
Effects on Ability to Drive and Use Machines: Not relevant.