PROSPECT Study
Sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
A Randomized Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation with a Short Cervix (PROSPECT)
You are being invited to participate in a research study. This flyer provides you with information about the study. A member of the research team will describe this study to you and answer all of your questions. Please read the information below and ask questions about anything you don’t understand before deciding whether or not to take part. Please tell the study doctor or study staff if you are taking part in another research study.
Prospect Study Information
Why is this study being done?
Studies have shown that women pregnant with twins are more likely to deliver their babies preterm (before 37 weeks of pregnancy) compared with women pregnant with one baby. Babies born preterm have a greater chance of having serious, long-term health problems or dying.
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.
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.
Other people in this study
Up to 75 mother baby-pairs from your area will participate in the study (75 moms, 150 babies). Up to 630 mother-baby pairs from around the country will be in the study.
What happens if I join this study?
If the length of your cervix measures less than 30 mm (about 1 inch), a member of the research staff may contact you to talk about taking part in the study in which you will be randomized (like choosing one of three numbers out of a hat) into one of three study groups:
- the pessary group will have a pessary placed around the cervix,
- the progesterone group will be given vaginal progesterone capsules, and
- the placebo group will be given vaginal placebo capsules (the capsules look like the progesterone capsules but contain no medicine).
What are the procedures of the study?
An exam will be done to look at your cervix to find out if it is opening or if you have an infection. During the exam, vaginal swabs will be collected. Vaginal swabs will also be taken at your first study visit between 26 and 30 weeks of pregnancy .
If you are randomized to the pessary group, a pessary will be placed around your cervix at your first study visit.
If you are randomized to either the progesterone group or the placebo group, you will place the study medication into your vagina at the first study visit. A research staff member will be there to help you. You will be given a one month supply of the study medication along with directions for daily use.
A research staff member will call you within one week of your first study visit to see how you are doing.
If you are randomized to the pessary group and feel discomfort in the pelvic area, you will be asked to visit the doctor to find out if the pessary should be moved or changed so that it feels better.
After the first study visit, you will meet with a member of the research staff every four weeks until the 35th or 36th week of your pregnancy.
At your second study visit after randomization (about 8 weeks after randomization) you will be asked to complete a questionnaire about your feelings on the pessary (if you were randomized to pessary) or on the study medication (if you are randomized to study medication).
The last in-person study visit will take place between the 35th and 36th week of your pregnancy. If you were randomized to pessary, the pessary will be removed at this visit. If you were randomized to study medication, all unused study medication is to be returned at this visit and no more study medication will be given.
You will continue to receive standard care (routine obstetrical care) from your doctor (your regular OBGYN) while you are in this research trial.
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.
What are the possible risks or discomforts?
If you are in the pessary group, you may feel discomfort during the placement of the pessary. You may have vaginal itching, vaginal odor or vaginal burning, no matter which treatment group you are randomized to. Your doctor will advise on treatment if necessary.
What are the possible benefits?
If you decide to take part in this research study, you and your babies may or may not directly benefit from your participation. If the study shows that treatment is successful, you and your babies may benefit if you are assigned to receive the progesterone medication or a pessary.
Are there alternative treatments?
The alternative to this study is not to participate and to continue receiving standard monitoring and care during pregnancy, labor and delivery.
Will I have to pay for anything/ Will I be paid for being in the study?
It will not cost you anything to be part of the study. We will compensate you $10 after each study visit
Is my participation voluntary?
If you are eligible, taking part in this research study is voluntary.
Who do I call if I have questions?
The researchers carrying out this study are Dr. Biggio and Dr. Tita. You may ask any questions you have now. If you have questions, concerns, or complaints later, you may call :
Dr. Biggio or Dr. Tita at:
205-934-5611
Study Title: A Randomized Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation with a Short Cervix – The PROSPECT Study
Principal Investigator: Joseph Biggio, MD and Alan Tita, MD
Study Coordinator: Stacy Harris
E-mail: stacylharris@uabmc.edu
Phone: (205)996-6262