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Endometriosis and microvascular dysfunction 3
Endometriosis, is a disorder that occurs in women, is when tissue that should be normally found inside the womb is also found in sites outside of the womb. Endometriosis is a disorder that is associated with systemic inflammation. This disorder impairs the function of the endothelium, the cells that line the body’s blood vessels (endothelium). The endothelium helps to control blood flow in healthy vessels. Women with endometriosis not only have an increased risk for high blood pressure and high cholesterol, they also have an increased risk for cardiovascular disease. With this study, we will learn how systemic inflammation in endometriosis impairs the lining of blood vessels and increases the risk for cardiovascular disease.We will use a short term intervention with a non-steroidal anti-inflammatory to examine how inflammation impact endothelial function in women with endometriosis
There will be 4 in person visits, at all visits blood will be drawn. Two of the visits will be experimental visits where we will measure skin blood flow and blood flow in the brachial artery. Participants will be required to take a placebo or the drug salsalate for 4 days prior to each experimental visit.
With and without Endometriosis
Pregnant and/or breastfeeding
Taking blood pressure medication
Known allergy to Salsalate
Healthy Mom Zone: Control Systems Engineering for Optimizing a Prenatal Weight Gain Intervention Study 2.0
The proposed overall research aims to establish feasibility of delivering an individually-tailored, behavioral intervention to manage gestational weight gain [GWG] that adapts to the unique needs and challenges of overweight/obese pregnant women [OW/OB-PW] and will utilize control systems engineering to optimize this intervention; in other words, make this intervention manage GWG in OW/OB-PW as effectively and efficiently as possible.
You will be randomized into an intervention or attention control group from ~8 weeks gestation to ~37 weeks gestation with a BMI of 25-45 (>40 with physician consent).You will have 1 pre-intervention session that explains the study procedures and to get you ready for the study. Here you will also complete various measures of demographics, behavioral surveys, etc.Over the course of the study, you will weigh yourself each day, wear an activity monitor and complete various surveys. If you are randomized to the intervention group, you may have healthy eating demonstrations and/or physical activity sessions each week.You will have 1 post-intervention session where you will return your devices, complete a 30-60 minute interview and complete the last of the surveys.
BMI 25-45 (>40 with provider consent)
Younger than 18
Prospective Cohort Assessing Novel Biomarkers of Early Pregnancy
The purpose of this research is to take and store blood, urine samples from pregnant women diagnosed by a positive pregnancy test or by ultrasound imaging. The purpose of this study is to determine a better way to diagnose the location and/or viability (chance of survival) of a pregnancy, as compared to current clinical care. Many women are found to be pregnant by a hCG (human chorionic gonadotropin) test which detects a hormone that is indicative of pregnancy. However, in early pregnancy, it is often difficult to see the pregnancy by ultrasound, which is called a pregnancy of unknown location (PUL). In early pregnancy, doctors do many tests (including blood tests and ultrasounds) to try to determine how far along the pregnancy is, whether it is healthy, and most importantly whether the pregnancy is growing in the right place. The doctors running this research project are trying to see if there are substances (biomarkers) in the blood or urine of a pregnant woman that can tell whether the pregnancy is a normal, healthy pregnancy, an ectopic pregnancy, or if pregnancy is not viable (miscarriage). To do this, blood and/or urine samples are being collected from women who have a pregnancy of unknown location, an ectopic pregnancy, women who are having a miscarriage, and women with a healthy growing pregnancy. The study will then look at a pre- determined panel of biomarkers that have been shown to be elevated (higher) or decreased (lower) in different types of pregnancy to determine the effectiveness and accuracy of this test in earlier diagnosing the viability and location of early pregnancy.
There will be one visit at the visit participants will be consented and following consenting blood and urine will be collected.
Live intrauterine pregnancy through 14 weeks, diagnosed by ultrasound demonstrating fetal heart motion
Diagnosed ectopic pregnancy
Pain or bleeding or at risk for ectopic pregnancy
Women seeking confimation of a pregnancy with a urine or serum pregnancy test (less than 14 weeks)
The HEALthy Brain and Child Development Study (HBCD)
This multi-site consortium research study, entitled the HEALthy Brain and Child Development (HBCD) study, will prospectively examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally through age 10 years. The study will determine the short- and long-term impacts of a variety of potentially harmful as well as protective environmental factors. These include prenatal substance use, mental health, stress, sociodemographics, biological and genetic factors, and parent/child interaction. The overall goal of this study is to understand the neurodevelopmental trajectories of children growing up in diverse environments. A sample of ~7,500 pregnant women will be recruited from 25 sites across the U.S. and they and their liveborn children will be followed for 10 years.
If you agree for you and your child to participate, we will ask you to take part in completing visits from pregnancy through the first 10 years of your child’s life. These visits will take place both in-person and remotely. The length of visits will vary and may last between approximately one to nine hours per visit (which can be broken up into multiple visits). Over the first four years of the study, all study visits will require about 33-37 hours total. This will include interviews, questionnaires and other tests about yourself and your child. We will ask you and your child to wear small devices for a few days to measure heart rate and or movement. We will ask you and your child to provide some biological samples. Because this study is looking at how a child’s brain develops in the first years of life, we will ask that you allow your child to have brain scans and other measures of how your child’s brain is developing. This study is being offered in both State College, PA at the University Park campus and in Hershey, PA at the College of Medicine campus. You may choose to complete this study at either site.
Speaks English or Spanish
Does not speak English or Spanish
Women and Infants' Stress and Health
The goal of this study is to understand how babies and their mothers learn to respond to stress during the early years of the baby's life. Participating women complete questionnaires and do a mildly stressful task alone (during pregnancy) or with their babies (at four different times over the first two years of the baby's life) and collect saliva samples that tell us about stress responses, either at home or at one of our lab sites. We aim to use what we learn to better support expecting parents who may be at risk for stress-related health problems and improve their children's resilience to stress throughout life.
Women are asked to participate in six sessions over Zoom and/or at the PACT Center between their 28th week of pregnancy and when their child is 2 years old. During these sessions, which last up to 2 hours each, mothers and babies will1.participate in mildly stressful tasks (like having the mother leave the room for up to 3 minutes and then return) and games to assess the baby’s emotional and cognitive development2.provide saliva samples by drooling into a tube (for the mother) or holding a cotton swab in their baby’s mouth to get it wet3.fill out questionnaires about themselves and their baby4.take part in clinical interviews that ask about mood and other markers of psychological ill-being
18 or older
Smart Connected Water Bottle and Lighting Devices: A Prenatal Pilot Study
We will conduct a pilot study to test feasibility of an innovative light device and blue-light glasses for promoting better sleep and a novel, smart water bottle for proper hydration. We will also examine women’s sleep and hydration behaviors in relation to their perceptions of pain, and obtain feedback from the participants on the overall patient intervention content to reduce prescription opioid use and promote behavioral pain management strategies after delivery.
Currently recruiting pregnant women who are in their 2nd or 3rd trimester.Attend a pre-session (in person OR remote) to explain the use of the water bottle, lighting devices, activity monitors, and weight scaleUse the devices for 22 days and complete surveys in your own homeAttend a post-session (in person OR remote) to return devices and participate an interview about the last 22 days
2nd or 3rd trimester
Reside around State College, PA
Diagnosed eating disorders/extreme dietary restrictions
Currently diagnosed with gestational diabetes
Currently diagnosed with pre-eclampsia
Mindful Moms study
This study (Mindful Moms) is being done to understand how an 8-week app-based mindfulness program called Calm impacts breastfeeding and maternal well-being. Eligible participants will be asked to complete three online surveys (each survey will take about 20 minutes) and take part in an 8-week app-based mindfulness program. Eligible participants will also be asked to take part in one online interview that will take about 25-30 minutes once the mindfulness program is over.
Participants will take part in one of two groups: A group asked to take part in a free 8-week app-based mindfulness program on their smartphone starting when they are 36 weeks pregnant or 4 weeks after delivery. The program will teach participants about mindfulness and breathing strategies to assist with calming their mind and body. or A group asked to take part in a free 8-week app-based mindfulness program on your smartphone starting 4 weeks or 12 weeks after they deliver. The program will teach participants about mindfulness and breathing strategies to assist with calming their mind and body. Participants will also be asked to complete three online surveys (each survey will take about 20 minutes) and take part in one online interview that will take about 25-30 minutes once the mindfulness program is over.
currently pregnant (12 to 34 weeks) or recently delivered (within the past 4 weeks)
intend to or are currently breastfeeding
daily access to a smartphone
willing to download a free mobile app
Management Of Pain After Cesarean Trial
This is a double blinded, placebo-controlled randomized controlled trial to test the efficacy of a combination of acetaminophen and ibuprofen administered to patients on schedule compared to ibuprofen and placebo on the patient's reported pain score on the second post-operative day after Cesarean delivery. We will also record opiate consumption and pain scores throughout the hospitalization of participants, and will survey patients at one and two weeks after surgery regarding opiate consumption and quality of life.
Planned delivery via C-section
Pfannenstiel ("bikini line") skin incision
Able to read and speak English fluently
Unplanned surgery (hysterectomy, bowel/bladder repair, cystoscopy)
Allergy or contraindication to study medication
History of opioid or other substance use disorder either before or during pregnancy
History of kidney or liver disease
The purpose of this study is to find genetic causes of recurrent pregnancy loss (RPL). RPL is defined by two or more miscarriages under 20 weeks gestation and affects approximately 5% of women.The causes of RPL are not well understood. After all the currently recommended testing for RPL has been done, about half of women with RPL will still have no identifiable cause. This lack of knowledge makes it difficult to provide effective medical care for couples with RPL.This study will compare reading about 20000 genes in the entire human genetic library by whole genome sequencing in the miscarriage material and also your and your partner’s DNA from blood samples. The DNA in a person is a combination of the DNA from each of their biological parents. If you have healthy children we may ask your consent for them to give a blood sample for DNA extraction and testing. Similarly, we may ask the same for other family members such as grandparents if necessary. We may also request your permission to use stored DNA or miscarriage material from previous pregnancy loss if available. Testing of family members or previous miscarriage materials may help to understand DNA sequence variants or changes identified in the miscarriage sample.
There will be a one time collection of blood samples.
Two or more prior losses of clinically recognized pregnancies
Prior losses are unexplained
Strong Foundations: Intervening to Promote Co-Parenting and Reduce Father Hazardous Drinking in Expectant Parents.
Our goal is to examine the efficacy of Strong Family Foundations parenting classes in reducing couple conflict, promoting co-parenting quality, parental sensitivity, and child development outcomes within families. We hope to enroll 220 couples in our parenting program. Participants will participate in parenting classes before and after the birth of their child, and research assessments 6 and 12 months postpartum.
Couples will be asked to participate in online parenting classes and family assessments during and after pregnancy. There are 3-5 prenatal and 1-4 postnatal classes that take place over Zoom. Family are also asked tp participate in 3 family assessments: 1 during pregnancy, 1 at 6 months of infant age, and one at 12 months of infant age. Families will be asked to complete inline surveys before each assessment. Additionally, families are asked to submit hair and saliva samples.
First time parents
18 years of age or above
Both parents living together
Not pregnant with first child
Parents not living together
Endometriosis and microvascular dysfunction
Endometriosis, is a disorder that occurs in women, is when tissue that should be normally found inside the womb is also found in sites outside of the womb. This disorder impairs the function of the endothelium, the cells that line the body’s blood vessels (endothelium). The endothelium helps to control blood flow in healthy vessels. Women with this disorder not only have an increased risk for high blood pressure and high cholesterol, they also have an increased risk for cardiovascular disease. They have a higher risk for cardiovascular disease, too. With this study, we will learn how endometriosis impairs the lining of blood vessels and increases the risk for disease. We will test two different intervention strategies to reduce long-term cardiovascular disease risk in women with endometriosis.
There will be 3 in person visits, blood draws will occur at all visits. On 2 of the visits blood flow experiments will be conducted. Participants will take oral medications.
Pregnant and/or breastfeeding
Taking blood pressure medication
Optimizing Maternal Nutrition: Adaptive trials and molecular methods to improve maternal and newborn health
Poor maternal nutrition is linked to poor birth outcomes. Current vitamin and mineral recommendations in pregnancy are based on limited data mostly from animal models and non-pregnant people. This study seeks to improve our understanding of the amounts of vitamins and minerals that are needed during pregnancy, to improve the health of women and newborns, especially in low-and middle-income countries. Nutrients travel around the body in blood, therefore part of the research is to understand how much blood and the watery component of blood (plasma) increases in pregnancy. This is a collaborative study with George Washington University (lead PI is there). The Penn State team will conduct pilot work to establish a method for measuring plasma volume in 2 phases. In phase 1, nonpregnant will be asked to attend one visit and plasma volume will be measured by injecting indocyanine-green (ICG, a green dye) and hydroxyethyl starch (HES, a form of starch) through an IV in the arm. In phase 2, pregnant women will be asked to attend 2 visits that are 4 weeks apart, but only HES (the starch) will be injected. For both phases (1 and 2), blood draws will occur at each visit and other non-invasive measurements will also be taken (e.g. weight, height, blood pressure). Each visit should take less than 2 hours and will be conducted at the Clinical Research Center in Noll Laboratory on the Penn State campus.
In phase 1, nonpregnant will be asked to attend one visit and plasma volume will be measured by injecting indocyanine-green (ICG, a green dye) and hydroxyethyl starch (HES, a form of starch) through an IV in the arm. In phase 2, pregnant women will be asked to attend 2 visits that are 4 weeks apart, but only HES (the starch) will be injected. For both phases (1 and 2), blood draws will occur at each visit and other non-invasive measurements will also be taken (e.g. weight, height, blood pressure). Each visit should take less than 2 hours and will be conducted at the Clinical Research Center in Noll Laboratory on the Penn State campus.
$50 per visit
Are generally healthy with normal blood pressure and BMI
Phase 1 - not pregnant
Phase 2 - are currently pregnant (22-32 weeks)
Currently have low or high blood pressure
Taking regular medication(s) prescribed by a physician
Phase 1 - pregnant or breastfeeding
Phase 2 - multiple/twin pregnancy
Coping with it All from Labor to Maternity
The CALM Project is looking to learn how different birthing classes prepare child-bearers for parenthood. Participants attend a free birthing class between their 20th and 37th weeks of pregnancy with their partners and fill out three questionnaires during pregnancy and postpartum. Three months after their baby is born, they are video-recorded interacting with their baby in their home and have their brain scanned using MRI. We aim to understand how different childbirth classes support mothers' well-being and bonding with their babies.
Women are asked to 1.complete 3 self-report questionnaires online during pregnancy and after their baby is born (45 minutes each)2.attend a childbirth preparation class (from a few hours to a 9-week class)3.participate in 2 in-person sessions (1.5 hours each): a videorecording with their baby in the home and a brain scan using MRI at Penn State Hershey Medical Center.
$160 + free birthing class
At least 18 years old
Pregnancy complications that would prevent you from participating in an online class
Central Pennsylvania Rural Birth Cohort
This study is being conducted to understand what strategies are most successful: 1) in building and retaining a cohort of families from rural communities in Central Pennsylvania with recruitment beginning in pregnancy, infant/toddler age, and preschool age using a cohort sequential design; 2) for collecting clinical and semi-invasive, remote-based biobehavioral measurements to better characterize synergistic factors associated with obesity and substance use in this high risk population; and 3) for identifying points for future intervention, treatment, prevention, and policy efforts to reduce health disparities in maternal-child morbidity and promote positive family processes.
During visit 1, all cohorts (cohort 1 at 16 weeks gestation, cohort 2 at 12 months post-delivery, and cohort 3 at 36 months post-delivery) will complete a survey that is expected to take 30-45 minutes. Each survey will be sent to you through email or will be mailed to you. The surveys will collect information about different lifestyle behaviors like your sleep, physical activity, eating, substance use, your stress and anxiety levels, your infant/toddler’s behavior, your parenting style, and your relationships with others in your life. You will also collect biological samples at home. These biological samples include hair and nail clippings. You will receive videos on how to collect and send the samples. You will be given pre-paid and addressed package to send your samples. The collection should only take about 15-20 minutes. If you are in cohorts 2 and 3, you will collect biological samples on them as well and you, your partner, and your child's interactions will also be observed via Zoom.Cohort 1 will follow the assessment schedule as described below:•Around 32 weeks gestation: complete the same survey as described above for visit 1•6 months post-delivery: complete the same survey as described above for visit 1 with additional surveys asking about your parenting and toddler•12 months post-delivery: complete the same survey as described above for visit 1 with additional surveys asking about your parenting and toddlerYou will have 4 study participation time-points, which will require active participation. The entire study participation will occur over 2 years. Active participation visits will last 30-105 minutes.Cohort 2 will follow the assessment schedule as described below:•At your toddler’s well-visits between 12-24 months, we will collect electronic health record data•24 months post-delivery: complete the same survey as described above for visit 1 with additional surveys asking about your parenting and toddler •36 months post-delivery: complete the same survey as described above for visit 1 with additional surveys asking about your parenting and toddler and you, your partner, and your child's interactions will also be observed via ZoomYou will have 4 study participation time-points, 3 of which will require active participation. The entire study participation will occur over 2 years. Active participation visits will last 30-125 minutes.Cohort 3 will follow the assessment schedule as described below:•48 months post-delivery: complete the same survey as described above for visit 1 with additional surveys asking about your parenting and toddler and you, your partner, and your child's interactions will also be observed via Zoom•60 months post-delivery: complete the same survey as described above for visit 1 with additional surveys asking about your parenting and toddlerYou will have 3 study participation time-points, all of which will require active participation. The entire study participation will occur over 2 years. Active participation visits will last 30-125 minutes.All electronic health record data will be extracted at the end of study participation.
Over the age of 18
Families with toddlers that are either 12 or 36 months of age
Live in rural Pennsylvania
Have smartphone/wifi access
Pregnant person or parents under age of 18
Families without toddlers that are either 12 or 36 months of age
Live outside of rural Pennsylvania
Do not have smartphone/wifi access