PROSPECT Study

STUDY BASICS

Are you pregnant with twins? Are you between 16-23 weeks pregnant and delivering at Magee-Womens Hospital of UPMC? If so, you may be able to participate in a research study to find out if the use of vaginal progesterone or a cervical pessary (a round, soft silicone device that goes around the cervix) can help prevent preterm birth. Compensation provided.

STUDY PURPOSE

A short cervix (which is the lower, narrow part of the womb) is more common in women carrying twins. Women who have a short cervix are more likely to deliver their babies preterm (before 37 weeks of pregnancy). Babies born preterm can have serious, life-threatening health problems. The purpose of this research study is to find out whether a pessary or vaginal progesterone lowers the risk of babies being born preterm to women with a short cervix. A pessary is a round, soft silicone device that goes around the cervix. Progesterone is a hormone naturally produced by the placenta.

COULD THIS STUDY BE RIGHT FOR YOU?

• Pregnant with twins
• Between 16-23 weeks pregnant
• Planning to deliver babies at Magee-Womens Hospital of UPMC

WHAT PARTICIPANTS CAN EXPECT

During the initial screening visit, participants will have an ultrasound. If the ultrasound shows that you have a short cervix, you will have a cervical exam and be randomly placed into one of three groups: 1) the pessary group will have a pessary placed around the cervix, 2) the progesterone group will be given vaginal progesterone capsules, and 3) the placebo group will be given vaginal placebo capsules (the placebo capsules look like the progesterone capsules but contain no medicine). The progesterone product used in this study contains peanut oil and should not be used if you are allergic to peanuts. Participants will have monthly study visits for questionnaires and assessments. The last visit will take place between weeks 35-36. If you received the pessary, it will be removed at this visit. If you received study medication, all unused medication will be returned. You will continue to receive routine care from your health care provider while you are in this study. After delivery, we will collect information about your pregnancy, labor, deliveries, and the health of your babies. We will review your and your babies’ medical records and will contact you by telephone.