The EASE Study

Official Title
A STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE MATERNA PREP DEVICE IN REDUCING PELVIC MUSCLE INJURIES DURING VAGINAL DELIVERY
Purpose

This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery.

Could this study be right for you?

You may be eligible for this study if you:
1. Are scheduled for vaginal birth.
2. Are pregnant with a single fetus.
3. Haven't given birth previously, or had a previous pregnancy terminated within 24 weeks gestation.
4. Are willing to comply with the protocol required follow-up visits.
5. Are able and willing to provide written informed consent prior to enrollment.
6. Are 18 years of age or older at time of consent.

You will be ineligible for this study if you:
1. Have a high likelihood of less than 1 hour of potential device dilation time after you arrive at the hospital.
2. Have a need for or is planning a Caesarean-section.
3. Begin labor with less than 36 weeks gestation.
4. Have a neurological disorder that could cause pelvic floor dysfunction, such as multiple sclerosis or spinal cord injury
5. Have a collagen-associated disorder that affects tissue elasticity, such as scleroderma or Ehlers-Danlos syndrome
6. Have a localized (genital tract) or systemic infection.
7. Have had prior surgical procedures to the vaginal anatomy which could lead to pelvic floor dysfunction, such as pelvic fractures or pelvic soft tissue injuries
8. Have any general health condition or systemic disease that may represent, in the opinion of the investigator, a potential increased risk associated with device use or pregnancy.
9. Have placenta previa or vasa previa.
10. Have a known significant chromosomal or structural fetal anomalies.
11. Have a category 2 and/or 3 fetal tracing that is unresolved.

Age Range
18 and up

A Study for New Moms about Pelvic Floor Disorders

Official Title
Pelvic Floor Disorders in the First Year After Childbirth: (PEACH Study)
Purpose

The goal of this study is to learn more about problems with urine or stool control, prolapse (feeling or seeing a vaginal bulge), and pain with sex, all which can affect mothers after delivery when they are most busy with their newborn.

If you join this study, you will complete a series of online surveys over a period of 12 months. The surveys will ask about urine and stool control, pelvic issues, and sexual issues. Each survey will take about 5-10 minutes.

Could this study be right for you?

You may be eligible if upon reading this, you:

- Have given birth within the last 10 days at The Ohio State University Wexner Medical Center
- Are 18 years of age or older
- Recently had a full term vaginal delivery of one baby
- Able to speak and read English

Age Range
18 and up

A Study on the Prediction of Preterm Birth

Official Title
Elastography and the Prediction of Preterm Birth Using E‐cervix
Purpose

This study will assess the use of elastography ultrasound using E‐cervix technology in the prediction of preterm birth before 37 weeks of their pregnancy in women with a history of preterm birth.

Could this study be right for you?

You may be eligible if you are :
* Pregnant women between the ages of 18‐50 years of age
* Scheduled for a routine anatomy ultrasound and cervical length measurement between 18‐24 weeks gestation.
* Prior preterm birth not induced between 16 weeks and 36 weeks of pregnancy
* Currently pregnant with one child

Exclusion Criteria
* Women with a cervical cerclage in place
* Women pregnant with multiples

Age Range
18 and up

A Study to Evaluate Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy

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

The purpose of this study is to understand how Continuous Positive Airway Pressure (CPAP)
for mild to moderate sleep apnea may affect hypertensive disorders of pregnancy and other
complications of pregnancy such as gestational diabetes.

Could this study be right for you?

1. No prior delivery at or after 20 weeks 0 days of gestation
2. Pregnancy with only one fetus
3. Gestational age at randomization between 14 weeks 0 days and 21 weeks 6 days
4. Diagnosis with mild to moderate OSA as defined by an AHI score ≥ 5 and <30

Age Range
18 and up

A Study of Mobile Health (mHealth), Breast Disease, and Lifestyle Modification

Official Title
Mobile Health (mHealth), Breast Disease, and Lifestyle Modification: Developing a Grounded Theory
Purpose

The purpose of this study is to understand breast cancer survivors use of mobile health (mHealth) apps for lifestyle behavior change - eating a healthier diet, exercising more, dealing with stress, & stopping smoking. Interviews will last approximately 60 - 90 minutes.

Could this study be right for you?

- You have a diagnosis of breast disease or are a breast cancer survivor.
- You are age 18 or older
- You are a female

Age Range
18 and up

A Resistance Training Study for Postmenopausal Women Ages 40-75

Official Title
Acute Inflammatory and Affective Responses to Varying Resistance Training Intensities in Postmenopausal Women.
Purpose

The primary aim of this study is to determine the effects of resistance exercise intensity on inflammatory markers and psychosocial response in postmenopausal women. Inflammation is part of your body’s immune response to various stimuli and is the body’s way of protecting itself from damage. It’s important to measure inflammation to determine the response to exercise. In this study, we aim to measure inflammation in the blood (what are called inflammatory markers) in response to three different resistance exercise intensities.

Could this study be right for you?

You may be eligible for this study if you are:
• Female, ages 40-75
• Postmenopausal (as diagnosed by a physician)
• Overweight (BMI >25 kg/m2)
• Physically capable to perform regular physical activity
• Recreationally trained (regular resistance exercise participation 2 times per week for the past 6 months)

Age Range
40 and up

A Treatment Study for Those with Moderate to Severe Postpartum Depression--The Hummingbird Study

Official Title
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-547 Injection in the Treatment of Adult Female Subjects with Severe or Moderate Post-partum Depression
Purpose

The purpose of this study is to evaluate the safety and effectiveness of an investigational medication in women with moderate to severe postpartum depression. The investigational medication is called SAGE-547 (allopregnanolone) . An investigational medication is one that is not yet approved by the United States Food and Drug Administration (FDA).

Could this study be right for you?

- Ages 18-45
- Currently depressed
- Less than 6 months postpartum

We will ask you to complete 4 study visits, including a Screening visit, a 3-day and night stay at the study center, and 2 follow-up visits.

Age Range
18 and up

A Study for Women Who are Carrying Twins (PROSPECT)

Official Title
A Randomized Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation with a Short Cervix (PROSPECT)
Purpose

The purpose of this research study is to determine if the use of a pessary or vaginal progesterone will reduce the likelihood of preterm delivery in mothers who are pregnant with twins who have a shortened cervix.

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 only 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 best treatment for pregnant women with twins who have a short cervix is not known. Some studies have shown that placing a pessary around the cervix or using vaginal progesterone may help to prolong the pregnancy.

Could this study be right for you?

- Women who are pregnant with twins
- Are between 16-23 weeks 6 days gestation, based on clinical information and evaluation of the earliest ultrasound
- Vaginal progesterone NOT used during pregnancy OR discontinued prior to 14 weeks gestation

Age Range
18 and up