Skip to main content

Table 1 Misoprostol dose escalation design

From: Efficacy and safety of administering oral misoprostol by titration compared to vaginal misoprostol and dinoprostone for cervical ripening and induction of labour: study protocol for a randomised clinical trial

Scenarios

Oral Misoprostol

Vaginal Misoprostol

Vaginal Dinoprostone

No or little uterine activity (UA)

Increase dose according to the regimen: 3 h on + 1 h off (Example 1)

Maintain regimen

Maintain regimen

Optimal UA

Maintain the dose and continue with the regimen (3 h on + 1 h off) (Example 2)

Maintain regimen

Maintain regimen

Active labour

Maintain the dose and continue with the regimen (3 h on + 1 h off) (Example 2)

Maintain regimen

Maintain regimen

Loss of UA after optimal UA

- When “off” drug: respect the period of rest and restart with dose depending on the previous level of UA (following the 3 + 1 regimen) (Example 3)

- When “on” drug: increase the dose and follow the 3 + 1 regimen (Example 4)

Maintain regimen

Confirm the presence of the drug in vagina:

- Lack of drug: administer additional dose.

- Presence: maintain regimen.

Active labour + loss of UA after optimal UA

When in combination with a lack of progression of labour, STOP treatment + oxytocin protocol

Active labour + no progress

STOP treatment + oxytocin protocol

Non-reassuring cardiotocographic pattern

STOP treatment + oxytocin protocol

Uterine tachysystole or hypertonicity

STOP treatment (if later UA falls below optimal levels, restart treatment with a lower dose than before the episode of hyperstimulation) (Example 5)

STOP treatment (if later UA falls below optimal levels, restart treatment)

STOP treatment (if later UA falls below optimal levels, start oxytocin protocol)

End of treatment without UA

Oxytocin protocol

End of treatment with UA

Watchful waiting + oxytocin protocol if loss of UA

  1. Optimal UA: at least 3 contractions lasting more than 60 s every 10 min
  2. Little UA: less than 3 contractions every 10 min
  3. Active labour: at least 4 cm of dilatation with optimal UA
  4. No progress of labour: The following criteria must be met:
  5. - Latent phase of labour completed and active phase of labour started (cervical dilation of 4 cm or more)
  6. - Contraction pattern of 3 contractions every 10 min with adequate intensity for 4 h without cervical changes
  7. Non-reassuring cardiotocographic trace:
  8. - Recurrent late decelerations lasting for 30 min or more
  9. - Atypical variable decelerations in more than 50% of the contractions for 30 min or more
  10. - Prolonged decelerations: decrease in foetal heart rate (FHR) by ≥15 beats per minute (bpm) for 2 to 10 min
  11. - Foetal bradycardia: FHR < 100 bpm for more than 10 min
  12. - Reduction in variability indicating a need for intervention
  13. - Sinusoidal FHR pattern
  14. Uterine tachysystole: Six or more contractions in 10 min for at least 30 min
  15. Hypertonicity: Sustained uterine contractions for more than 2 min without complete uterine relaxation
  16. Uterine hyperstimulation: Excessive uterine activity with abnormal FHR