Dinoprostone Insert / Prostaglandin E2 (Cervidil®)

Section 2.1

Midwives may administer this drug after consulting with and on the order of a medical practitioner.

This is a vaginal insert which contains 10 mg of dinoprostone (prostaglandin E2) in a controlled-release formulation. The vaginal insert is a thin, flat, wafer which is rectangular in shape with rounded corners contained within the pouch of an off-white knitted polyester retrieval system. The dinoprostone in the vaginal insert is released at approximately 0.3 mg/hour and, once in the plasma, is rapidly cleared and metabolized by most tissues.

Indications and Clinical Use:

For in-hospital use, Dinoprostone Insert/Prostaglandin E2 (Cervidil®) is primarily used as a method of ripening the cervix in preparation for labour or inducing labour in the presence of a medical or obstetrical indication for the induction of labour. Prostaglandin has been recommended over the use of oxytocin for induction of labour as the preferred method of induction of labour, unless there are specific clinical reasons for not using it.

Dinoprostone Insert/Prostaglandin E2 (Cervidil®) can be used in the presence of rupture of membranes (ROM); please refer to warnings and precautions below.

In the presence of ROM, the following options should be offered: expectant management or induction of labour with prostaglandin or oxytocin.

Contraindications:

Known hypersensitivity to prostaglandins, clinical suspicion or definite evidence of any condition where labour is contraindicated – including abnormal fetal status, unexplained vaginal bleeding, placenta previa, vasa previa, cord presentation, cephalopelvic disproportion, active genital herpes, pelvic structural deformities, and cervical carcinoma. It is not recommended if there is a history of previous cesarean section or major uterine surgery, high parity ≥6 term pregnancies, multiple pregnancy, polyhydramnios, fetal malpresentation, history of epilepsy, and should not be used simultaneously with other oxytocics.

Warnings and Precautions:

There may be an increase in chorioamnionitis with rupture of membranes and induction of labour with vaginal prostaglandin compared to when oxytocin only is used, but less than with expectant management.

Pregnancy:

First 28 weeks of pregnancy – Contraindicated unless for termination/evacuation
Pregnancy near or at term – Compatible

Lactation:

Category L3 – No Data – Probably Compatible (but will be well-metabolized before lactogenesis)

Adverse Reactions:

Hypotension, syncope, tachycardia, dizziness, hyperthermia, nausea, vomiting, diarrhea, tachysystole, hypertonus, hyperstimulation, abnormal fetal heart tones.

Dosage and Administration:

Dinoprostone (Cervidil®) 10 mg vaginal insert digitally placed transversely deep in the posterior fornix of the vagina ensuring there is no visible string exposed outside the vagina.

Onset of Action:

Time to peak: 0.5-1 hour

Half-life:

2.5-5 minutes

  • Dinoprostone Insert/Prostaglandin E2 (Cervidil®) should be removed after 12-24 hrs or at the onset of active labour.
  • If cervical ripeness is not achieved in 12-24 hrs and Dinoprostone Insert/Prostaglandin E2 (Cervidil®) has been removed, it may be repeated as needed.
  • Oxytocin infusion may be started 30 minutes after Dinoprostone Insert/Prostaglandin E2 (Cervidil®) has been removed if cervix is favourable. Please see section: Induction and Augmentation of Labour – Oxytocin.
  • Dinoprostone Insert/Prostaglandin E2 (Cervidil®) must be removed: a) when active labour is established b) in the presence of excessive uterine activity such as in hyperstimulation or hypertonus c) in the presence of an abnormal fetal heart rate pattern.

If fetal heart assessment is atypical:

  • Follow FH Surveillance/Intrapartum Electronic Fetal Monitoring guidelines.
  • Consult with a physician to seek guidance regarding management plan.

If fetal heart assessment is abnormal:

  • Remove the Dinoprostone Insert/Prostaglandin E2 (Cervidil®), institute immediate intrauterine fetal resuscitation, prepare for expedited birth and immediately consult with a physician.

If Dinoprostone Insert/Prostaglandin E2 (Cervidil®) has been removed for tachysystole or hypertonus (more than 5 contractions in 10 minutes over 30 minutes or one contraction lasting more than 2 minutes):

  • Immediately consult with a physician.
  • A tocolytic such as nitroglycerin may be administered.

For tachysystole or hypertonus (six or more contractions in 10 minutes averaged over 30 minutes and/or the presence of moderate/strong contraction(s) lasting more than 90 seconds and/or less than 30 seconds of adequate resting tone between contractions) and if fetal heart is abnormal:

  • Immediately consult with a physician. A tocolytic such as nitroglycerin may be administered.

*Administration of nitroglycerin should be accomplished while simultaneously arranging an emergency consult with a physician.

(See section on Nitrates for administration)