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Women's Health Services

Research Opportunities


IRB Approved January 12, 2021


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 being done?

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 if 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 16-24 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.


IRB Approved November 16, 2021


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

A Randomized Trial of Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy

What is Sleep Apnea?

Sleep apnea is a sleep disorder that affects the quality of your sleep and your daytime functioning. Normally during sleep, air moves through the throat and in and out of the lungs at a regular rhythm. In a person with sleep apnea, air movement is periodically diminished or stopped. In obstructive sleep apnea, breathing is abnormal because of narrowing or closure of the throat.

Sleep apnea is common in pregnancy. About one in five women who are overweight or report snoring will test positive for sleep apnea in pregnancy.

What are the symptoms of Sleep Apnea?

The symptoms of sleep apnea in women may not be the same as those in men. For women, symptoms may be mistaken for depression or other medical conditions.

Nighttime Symptoms*

  • Frequent or load snoring, gasping or snorting sounds
  • Difficulty falling asleep, frequent awakenings
  • Restless sleep, changes in dreaming
  • Frequent bathroom visits at night
  • Nighttime heartburn

Daytime Symptoms

  • Feeling tired, drained, or lacking energy
  • Feeling sleepy or falling asleep at the wrong time or place
  • Feeling depressed, anxious, or irritable
  • Forgetfulness, lack of focus

*Some of these symptoms could be observed by a bed partner or roommate

Sleep Apnea is treatable

The most commonly prescribed treatment for sleep apnea is continuous positive airway pressure or CPAP

Weight loss, adjusting sleep positions, and avoiding alcohol or other sedatives also can help. Treatment of sleep apnea has been shown to help women sleep better and function better, both physically and mentally during the day.

More research is being done to understand the other possible health benefits of treatment.

What is the SLEEP study?

The Maternal Fetal Medicine Units SLEEP trial is a study of using CPAP in pregnancy.

The goal is to understand if using CPAP in pregnancy can help women have healthier pregnancies.

How will I know if I am eligible?

The first part of the study involves going home with a portable sleep monitor. Wearing this monitor for one night will let research staff see if you have sleep apnea.

If you test positive for mild or moderate sleep apnea, you will be eligible for a treatment trial in pregnancy.

If you agree to participate in the trial, you will be randomly (like the flip of a coin) assigned to one of two groups:

  • Sleep advice and treatment with CPAP
  • Sleep advice only

If you are in the CPAP group, we will teach you how to use, clean and track your device usage. We will help you get used to sleeping with CPAP and encourage you to sleep with it every night.

If you agree to participate in the trial, we will follow you throughout pregnancy and collect data on your prenatal care and delivery. Part of your participation may include collection of blood samples and asking you to complete sleep related surveys.

You will be compensated for your time and effort.