Effect of vaginal progesterone among patients with a shortened cervix

Perinatal Center of Iowa (PCI) is participating in a clinical trial sponsored by National Institutes of Health (NIH) Perinatal Research Branch and Columbia Laboratories, Inc. The study is titled “The Effect of Vaginal Progesterone Administration in the Prevention of Preterm Birth in Women with a Short Cervix [Also Known as: Vaginal progesterone bioadhesive gel (Prochieve)® Extending Gestation A New Therapy for Short Cervix - Trial (PREGNANT Short Cervix - Trial)”, and is available for review online.

This international, multi-center, double blinded, randomized controlled trial is looking at the effect of vaginal progesterone among patients with a cervical length between 10-20 mm between 190 and 236 weeks of gestation. Patients will be randomized to placebo vs. progesterone bioadhesive gel from the time of enrollment until PPROM, 36 weeks of gestation or delivery.

The study requires an initial transvaginal ultrasound (TVU) screening between 190 and 236 weeks of gestation, and if qualified, the patient can be consented to participate in the trial. Once the patient agrees to the trial and starts drug therapy, the patient can be managed in an obstetrical standard that you feel is appropriate. She can remain in your practice for the duration of the pregnancy.

We feel this is an important trial which will help us change our treatment options for those patients with a short cervix in early pregnancy. Please consider counseling your patients for this important trial, and contact us if a patient is interested.