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Controlled Release Dinoprostone Insert and Foley Compared to Foley Alone: A Randomized Pilot Trial
Rodney K Edwards1, Michelle L Norris1, Mitchell D West2
1Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma.
American Journal of Perinatology
|March 3, 2020
Summary
This pilot study found that combining dinoprostone vaginal insert with Foley catheter may reduce time to vaginal delivery for nulliparous women. However, this combined method did not show a significant benefit for parous women compared to Foley catheter alone.
Area of Science:
- Obstetrics and Gynecology
- Reproductive Medicine
Background:
- Cervical ripening and labor induction are critical in managing term pregnancies.
- Various methods exist for cervical ripening, each with potential benefits and drawbacks.
Purpose of the Study:
- To compare the efficacy of a combined dinoprostone vaginal insert and Foley catheter (DVI + Foley) versus Foley catheter alone for cervical ripening and labor induction.
- To evaluate the primary outcome of time to vaginal delivery in a pilot randomized controlled trial.
Main Methods:
- An open-label pilot randomized controlled trial was conducted with 100 women at ≥37 weeks gestation.
- Participants were randomized to receive either DVI + Foley or Foley alone for cervical ripening.
- Oxytocin was administered post-ripening in both groups; parity was a stratification factor.
Main Results:
- For nulliparous women, the median time to vaginal delivery was significantly shorter with DVI + Foley (21.2 hours) compared to Foley alone (31.3 hours) (p=0.05).
- For parous women, no significant difference in median time to vaginal delivery was observed between the DVI + Foley (17.1 hours) and Foley alone (14.8 hours) groups (p=0.21).
- Cumulative incidence functions were used to analyze the competing risk of cesarean delivery.
Conclusions:
- Combined dinoprostone vaginal insert and Foley catheter may shorten the time to vaginal delivery in nulliparous women.
- This combination therapy did not demonstrate a significant benefit in reducing time to vaginal delivery for parous women.
- Further research may be warranted to explore optimal induction strategies based on parity.
