Active Research Studies & Recruitment
At the forefront of innovation, our research teams are dedicated to tackling age-old challenges in women’s health through scientific discovery, clinical trials, and implementation research. In 2023, we raised over $26 million to support these critical efforts and proudly ranked among the top 10 Ob-Gyn departments nationally in NIH funding. This strong investment fuels the development of novel approaches that have the potential to transform patient care and improve outcomes for families across the globe.
Our teams’ relentless commitment to excellence is evident in the nearly 280 peer-reviewed papers published in 2023, which contribute to advancing clinical practice, shaping health policy, and inspiring new avenues for scientific exploration. This research not only propels medical progress but also directly benefits our patients—offering them the latest, evidence-based treatments and giving families hope for a healthier future.
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Please review the list below of ongoing and upcoming studies in our department:
Purpose: This study addresses the high rates of maternal morbidity and mortality (3M) in the U.S., with a focus on the racial and ethnic disparities disproportionately affecting non-Hispanic Black women. Hypertensive disorders of pregnancy, a significant contributor to 3M, are examined as a preventable cause of maternal complications and deaths. Researchers from ´óÏó´«Ã½ are partnering with the NC Department of Public Health, Piedmont Health Services, and community organizations to adapt and implement the Severe Hypertension During Pregnancy and Postpartum Safety Bundle in outpatient, community-based settings. The project aims to improve hypertension care and outcomes, particularly for medically vulnerable populations, while addressing social determinants of health and promoting equitable, respectful care. 
Contact: Kate Menard (kate_menard@med.unc.edu)
Purpose: Study of whether two different doses of aspirin 81 mg vs 162 mg daily, will lower the risk of having another preterm delivery or fetal death in women with prior preterm birth less than 35 weeks 0 days.
Contact: Kelly Clark or Molly Leatherland via EPIC message or email obresearch@unc.edu
Study Name: A Phase 3 Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
Purpose: ´óÏó´«Ã½ OBGYN and Maternal Fetal Medicine are participating in the Azalea clinical trial with Janssen Pharmaceuticals, aimed at treating pregnant women diagnosed with red blood cell alloimmunization—a condition in which the body produces antibodies against foreign red blood cells. The Azalea Trial is focused on evaluating the efficacy and safety of Nipocalimab, an investigational medication, in pregnancies at risk for severe hemolytic disease of the fetus and newborn (HDFN). Most recently, Dr. Goodnight’s team at ´óÏó´«Ã½ has just successfully treated and delivered the first mother participant and healthy baby in the world as part of this trial!Ìý
IRB #: 23-2842
Contact: Call us at 919-867-4760
For more on the ´óÏó´«Ã½ Fetal Care Center
Purpose: The purpose of this study is to find how umbilical cord blood can be used to find better ways to treat patients with leukemia, bone marrow failure, and certain rare inherited diseases. The purposes are to: collect, process and store umbilical cord blood from single, healthy baby births; examine the safety and efficacy of unrelated donor cord blood transplants; evaluate the closeness in tissue type matching (HLA) between the cord blood unit and recipient; study other factors that contribute to transplant recipient survival such as how well the cord blood engrafts; examine whether the way the cord blood is collected, processed and stored has any effects on survival and complications after transplant.
IRB #: 00-0723
Contact: Phone: 984-974-0918
Purpose: This study aims to assess long-term outcomes for children born to women with mild chronic hypertension (CHTN) who either received antihypertensive treatment during pregnancy or developed preeclampsia. The study will involve 400 children aged 7 years or older, whose mothers participated in the CHAP study. Each participant will complete a single in-person visit, which will last 2-3 hours and include medical history review, collection of urine and saliva samples, and completion of questionnaires. This visit is scheduled alongside a maternal visit
IRB #: 24-1496
Contact: Call Kathia Pena at 984-291-7738 or email kathia_pena-centeno@med.unc.edu
Purpose: This study aims to assess long-term outcomes for children born to women with mild chronic hypertension (CHTN) who either received antihypertensive treatment during pregnancy or developed preeclampsia. The study will involve 400 children aged 7 years or older, whose mothers participated in the CHAP study. Each participant will complete a single in-person visit, which will last 2-3 hours and include medical history review, collection of urine and saliva samples, and completion of questionnaires. This visit is scheduled alongside a maternal visit.
IRB #: 22-3335
Contact: Call Kathia Pena at 984-291-7738 or email kathia_pena-centeno@med.unc.edu
Purpose: The purpose of this study is to find how umbilical cord blood can be used to find better ways to treat patients with leukemia, bone marrow failure, and certain rare inherited diseases. The purposes are to: collect, process and store umbilical cord blood from single, healthy baby births; examine the safety and efficacy of unrelated donor cord blood transplants; evaluate the closeness in tissue type matching (HLA) between the cord blood unit and recipient; study other factors that contribute to transplant recipient survival such as how well the cord blood engrafts; examine whether the way the cord blood is collected, processed and stored has any effects on survival and complications after transplant.
IRB #: 21-1459
Contact: Molly Leatherland 919-500-9935 or obresearch@unc.edu
Purpose: This study aims to determine whether delivery at 35 weeks in stable patients with gastroschisis provides better outcomes compared to observation and planned delivery at 38 weeks. The study will enroll 800 pregnant women diagnosed with gastroschisis before 33 weeks’ gestation, with around 100 participants from ´óÏó´«Ã½. This randomized, multi-center trial across NAFTNet institutions will assign participants at 33 weeks to either early delivery at 35 weeks or continued observation with a target of 38 weeks. The primary outcome will assess rates of stillbirth, neonatal death before discharge, respiratory issues, and need for parenteral nutrition at 30 days.
IRB #: 19-0900
Contact: Amber Ivins (aivins@med.unc.edu)
Purpose: In collaboration with the University of Utah,ÌýThe Meaning of ScreeningÌýis a research study that seeks to enhance how expectant parents understand and make decisions about prenatal screening. This study aims to identify the most effective ways to educate pregnant couples on this vital topic, helping them feel informed and confident in their choices.
IRB #: 21-2742
Contact: Call us at 984-291-7737
Purpose: trial for scheduled and unlabored cesearens that will be adding azithromycin to the routine clinical antibiotic prior to to surgical incision to determine if giving a second antibiotic will reduce the risk of developing endometritis, wound infection, or sepsis. The research staff will provide the study medication and will follow the participants through 6 weeks postpartum to assess any post op complications.
IRB #: 24-2210
Contact: Kelly Clark or Molly Leatherland via EPIC message or email obresearch@unc.edu
Contact: mail protectmc@unc.edu or call 984-280-5225
Purpose: ´óÏó´«Ã½ PTBCARE+ is a randomized control trial study that will test whether a personalized patient support program during pregnancy can decrease stress, reduce racial and ethnic health disparities, and improve birth outcomes. The ´óÏó´«Ã½ PTBCARE+ study will plan to enrollÌýOBGYN patients who are at risk for spontaneous or medically indicated preterm birth and or other pregnancy related complications. The PTBCARE+ team will include research staff who have received special training in providing support to high-risk pregnancy populations, and team members from the ´óÏó´«Ã½ Perinatal Mood Disorders Program.Ìý
IRB #: 23-1779
Contact: Email ptbcare@unc.edu or call 970-782-2273
Purpose: This randomized controlled trial (RCT) compares CPAP therapy to standard care in women with mild to moderate sleep apnea to assess its effectiveness in preventing hypertensive disorders of pregnancy (HDP).
IRB #: 18-0647
Contact: Kelly Clark or Molly Leatherland via EPIC message or email obresearch@unc.edu
Purpose: A randomized control trial to find out if a type of group prenatal care focused on lifestyle changes can help improve the health of pregnant people who are at risk of developing gestational diabetes, compared to regular, one-on-one prenatal care. We will follow patients through their pregnancy and for 12 weeks after giving birth to see if TLC group care leads to better maternal and neonatal outcomes.
IRB #: 23-2333
Contact: Catalina Montiel, 984-528-4236, tlcstudy@unc.edu
Purpose: Determine if two community-designed interventions can improve disparities in maternal and infant morbidity. Primary outcomes are low birth weight, emergency care visits and hospitalizations during pregnancy and postpartum, maternal mood symptoms and discrimination in medical settings. There are a variety of other outcomes we will obtain from EHR data.
Contact: rachel_peragallo@med.unc.edu
Purpose: There are multiple factors and barriers that lead to inequities surrounding female permanent contraception, or sterilization. These include factors at the patient-level as well as barriers at the clinician-, hospital-, and policy-levels. This study aims to further characterize the clinical disparities, public health impact, ethical complexities, and need for policy reform.
Contact: kavita_arora@med.unc.edu
Purpose: The purpose of this Phase I study is to investigate the use of artesunate vaginal pessaries as a treatment for cervical precancer among women screening positive for cervical precancer (CIN 2/3) who need excisional treatment. The trial will enroll 18 HIV-positive and HIV-negative women. It will assess the safety, adherence, and acceptability of self-administered pessaries, as well as histological regression to CIN 1 or less following treatment.
IRB #: 23-0903
Contact: cmungo@email.unc.edu
Purpose: The purpose of this Phase II randomized, placebo-controlled trial is to evaluate whether self-administered artesunate pessaries can be used as adjuvant therapy following thermal ablation to improve HPV treatment outcomes in women living with HIV. This trial will enroll 120 HIV-positive and HPV-positive women who will be randomized 2:1 to artesunate or matched placebo. Secondary aims include assessing safety, adherence, and acceptability of self-administered artesunate alongside study uptake and retention through week 24.
IRB #: 24-0370
Contact: cmungo@email.unc.edu
Purpose: In the wake of the US Supreme Court’s 2022 Dobbs v Jackson Women’s Health Organization decision, which overturned federal protections on abortion, obstetrician-gynecologists (OB-GYNs) face policy-related threats to their personal and professional wellbeing. The Study of OB-GYNs in Post-Roe America (SOPRA) investigates the relationships between state abortion policy environments, OB-GYNs’ work experiences and stressors, and their health and wellbeing. It also identifies organizational-level policies and practices that may buffer negative effects of policy-related stressors on OB-GYNs. By generating rigorous scientific evidence and actionable recommendations to help healthcare organizations support OB-GYNs, SOPRA aims to protect and promote the health and wellbeing of this essential workforce.
Contact: kavita_arora@med.unc.edu
Purpose: Many individuals experience various circumstances during pregnancy related to food access, housing stability, transportation availability, and personal safety—social factors that can influence pregnancy outcomes. Healthcare providers recognize the importance of these social drivers of health but often lack systematic ways to identify these circumstances and connect patients with supportive resources during prenatal care. At ´óÏó´«Ã½, we have newly integrated a standardized approach for screening and resource connection across our four main prenatal clinics. We’re carefully evaluating this process by collecting information and gathering feedback from both clinical staff and patients. Our goal is to continue to refine our approach to make it effective, sustainable, and patient-centered to continue to enhance the care experience and supportÌýpositive maternal-infant outcomes for all those we serve.
IRB #: 24-3104
Contact: ÌýPaige Anderson (Paige_Anderson@med.unc.edu)
Purpose: This is a pilot cohort of pregnant and postpartum people recruited from a prison prenatal clinic with follow-up through three months postpartum to learn about their pregnancy, substance use, and incarceration experiences.
IRB #’s: 21-2379, 20-3559
Contact: Andrea Knittel (andrea_knittel@med.unc.edu)Ìý
Purpose: This mixed methods study aims to quantify the scope of perinatal incarceration in North Carolina and assess the feasibility of a pre-trial diversion intervention for pregnant people with substance use disorders.
IRB #’s: 22-1508, 23-1586, 24-0216
Contact: Andrea Knittel (andrea_knittel@med.unc.edu)Ìý
Purpose: This blinded, randomized controlled trial (RCT) will compare two low doses of aspirin—81 mg and 162 mg—to evaluate which is more effective at preventing hypertensive disorders in pregnancy and improving maternal and infant outcomes.
IRB #: 24-1181
Contact: Kelly Clark or Molly Leatherland via EPIC message or email obresearch@unc.edu
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Purpose: This randomized, open-label trial will compare the effectiveness of oral metformin versus injectable insulin in treating gestational diabetes during pregnancy. Participants will be randomly assigned to either the metformin or insulin treatment group. The study team will monitor participants from pregnancy through delivery and up to two years postpartum, collecting data, surveys, biological samples, and additional relevant information throughout the study period.
IRB #: 24-1860
Contact: Epic message Leah Bell or email decide@unc.edu
Purpose: This study aims to estimate cardiovascular disease (CVD) risk in both healthy and medically complicated pregnant women and their infants. It will involve 840 mother-infant pairs across multiple sites, with half being healthy and half having conditions (such as hypertension, diabetes, or obesity) that could increase future CVD risk. This prospective, observational study will enroll diverse pregnant women between 34-40 weeks’ gestation, with follow-up visits within 72 hours after delivery and at 6 and 12 months postpartum. At each visit, the study will assess arterial stiffness, cardio-metabolic and inflammatory markers, neonatal fat mass, and collect maternal and neonatal health data. Additionally, blood, serum, and microbiome samples will be stored for future analysis.
IRB #: 21-2131
Contact: email MIDASstudy@unc.edu or call 984-291-7736
Purpose: To generate data, engineering, and analytical solutions that will contribute to the development of robust, inexpensive, widely-deployable ultrasound technologies that can assess gestational age and other important obstetric conditions with minimal operator expertise.
Contact: FAMLI phone 984-358-2055
Purpose: To generate data, engineering, and analytical solutions that will contribute to the development of robust, inexpensive, widely-deployable ultrasound technologies that can assess gestational age and other important obstetric conditions with minimal operator expertise.
IRB #: 24-1415
Contact: Phone: 984-358-2055