Research Opportunities

Institutes & Services > Women's Services

PROSPECT Study

IRB Approved January 12, 2021

Contact

Research Nurse: (513) 862-2330
Marta McClellan MSN, RN, CCRC
Principal Investigator: Mounira Habli MD
Maternal Fetal Medicine

A Randomized Trial of Pessary and Progesterone for Preterm Birth Prevention in Twin Gestation with a Short Cervix

This study plans to learn more about whether a pessary {round, soft silicone device that fits around the cervix) or vaginal progesterone (hormone normally produced by the placenta) lowers the risk of twin babies being born preterm to women with a short cervix. The cervix is the lower narrow part of your womb.

Why is this study beingdone?

Studies have shown that women who are pregnant with twins are more likely to deliver their babies preterm (before 37 weeks of pregnancy) when compared with women who are pregnant with one baby. Babies born preterm have a greater chance of having serious, long-term health problems or dying.

A short cervix 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 iif used by mother are pregnant with twins and have a shortened cervix, lowers the risk of their babies being born preterm.

Who can join the study?

Women who are pregnant with twins and between 1 6-24 weeks gestation that have a shortened cervix (less than 30 mm, which is about 1 inch) may be eligible.

What will be asked of me?

You will be consented for the study and scheduled for a vaginal speculum exam and vaginal swab testing. You will be randomized (like choosing one of three numbers out of a hat) into one of three treatment groups:

  • Daily vaginal progesterone (medicated pill to place in your vagina)
  • Arabin Pessary (round, soft device that fits around the cervix)
  • Placebo ( a plain pill to place in your vaginal that contains no medication)

You will meet with the research nurse every month until delivery for medication refills or pessary follow-up. If you are taking vaginal medication, you will continue to take It until you are 36 weeks pregnant. If you are randomized to Arabin Pessary, it will remain in place until 35-36 weeks, at which time a physician will remove it at a clinic appointment.

How Many People will be in this study?

At TriHealth up to 50 mothers and their babies will participate in the study. (50 moms, 100 babies). Up to 630 mother and their babies from other hospitals around the USA will also participate in the study.

Will I be paid for being in the study?

You will receive monetary compensation for your time to participate in the study.


TOPS Study

IRB Approved January 12, 2021

Contact

Research Nurse: (513) 862-2330
Marta McClellan MSN, RN, CCRC
Principal Investigator: Mounira Habli MD
Maternal Fetal Medicine

A Randomized Trial of Pessary in Singleton Pregnancies with a Short Cervix

This study plans to learn more about whether a pessary (round, soft silicone device that fits around the cervix) lowers the risk of babies being born preterm to women with a short cervix. The cervix is the lower, narrow part of your womb.

Why is this study being done?

Studies have shown that women who have a short cervix (the lower narrow part of the uterus) are more likely to deliver preterm. Babies born preterm have a greater chance of having serious long-term health problems or dying.

The purpose of this study is to find out whether the use of pessary lowers the risk of a baby being born too soon to women who have a short cervix. A pessary is a round, soft silicone device that fits around the cervix. Who can join the study? Women who are pregnant with one baby and between 1 6 and 24-weeks’ gestation who have a shortened cervix (less than or equal to 20 mm, which is about 3/4 of an inch) may be eligible.

What will be asked of me?

You will be consented for the study and scheduled for a vaginal swab testing. You will be randomized (like flipping a coin) Ii nto one of two groups:

  • Arabin Pessary (round ,soft device that fits around the cervix)
  • No Pessary

You will meet with a research nurse every month until delivery for a study visit to ask questions about your health during your pregnancy. IIf you are randomized to the Arabin Pessary, it will remain in place until around 36 weeks, at which time a physician will remove it at a clinic appointment.

How many people will be in this study?

At TriHealth up to 100 mothers and their babies will participate in the study (100 moms,100 babies) Up to 825 mothers and their babies from other hospitals around the USA will also participate in the study.

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