Ripening Approaches for Prompt Induction and Delivery - Sequential Versus Concurrent Dilapan-S and Misoprostol to Achieve Vaginal Delivery (RAPID-DS)

Summary

The purpose of this study is to compare the effectiveness of sequential versus combined multimodal cervical ripening strategies to achieve vaginal delivery within 24 hours among nulliparous patients with singleton, vertex pregnancies at term undergoing induction of labor.

Eligibility

Age range

18+ years

Sex

Female

Healthy volunteers

No

Interventions

• Combination Product
  Sequential Cervical Ripening

  Those assigned to sequential cervical ripening will be scheduled with a trained physician for placement of Dilapan-STM osmotic cervical dilators in the outpatient setting at 12 to 24 hours prior to their scheduled labor and delivery admission. Upon admission to labor and delivery, sequential patients will have Dilapan-S removed during clinical vaginal exam and will receive misoprostol 25 mcg every two hours up to 8 doses until modified Bishop score is greater than 4, warranting transition to oxytocin infusion.

• Combination Product
  Inpatient Combined Cervical Ripening

  Those randomized to scheduled induction of labor in the inpatient setting will present as scheduled to labor unit, at which time they will undergo clinical assessment and will receive placement of Dilapan-S by a trained physician along with misoprostol 25 mcg every 2 hours up to 8 doses or until clinical exam demonstrates modified Bishop score greater than 4, warranting transition to oxytocin infusion.

Location