MFM Protocols

The Obstetric and Neonatal Outcomes Study (ONOS) Pregnancy Cohort

The primary purpose of this protocol is to create a biorepository of biological samples along with health information from pregnant women (<20 weeks gestation) and their babies in order to identify risk factors, biological, and/or genetic markers for long-term health outcomes in future IRB analysis protocols. Collected biological specimens will include maternal urine, maternal stool, maternal and cord blood, and maternal placental samples. Samples will be collected at the initial prenatal visit, (<20 weeks), 26-34 weeks, and delivery at the University of Virginia Health System.

Use of Continuous Glucose Monitoring to Screen and Track Dysglycemia in Pregnancy

Continuous glucose monitoring will be used during each trimester to determine if gestational diabetes can be diagnosed early in pregnancy.  We will characterize longitudinal changes in CGM derived glucose patterns throughout pregnancy in women at high risk of developing diabetes.  We will also used Mixed Meal Tolerance Tests to measure plasma glucose, Insulin, and C-peptide throughout pregnancy.

Understanding the mechanical properties of uterine tissue in pregnant and non-pregnant women

Two known major causes of preterm births (PTB) are uterine overdistension (e.g. multifetal pregnancies) and premature cervical softening/dilation. We hypothesize that the mechanical environment of pregnancy is implicated in many PTBs. Our primary aim is to characterize the mechanical properties of uterine tissue from nonpregnant, normal pregnant non-laboring, pregnant laboring, and preterm birth patients. We hypothesize that the uterine tissue of non-pregnant women will be stiffer, that pregnancy leads to softening of uterine tissue, and that the uterine tissue in women with preterm births will have the lowest fiber stiffness parameter.

 Development of a Prediction Model of Fetal Growth Restriction Using Deep Learning Techniques

We plan to create a predictive model using deep learning techniques to predict fetal growth restrictions (FGR). We aim to develop deep learning networks that may be used for the improved identification of women at risk from specific pregnancy complications.   Our application will focus specifically on the adverse pregnancy outcome known as fetal growth restriction (FGR).

Assessing the Feasibility of a Remote Patient Monitoring/Home Telehealth Hybrid Platform for High-Risk Obstetric Patients

We have implemented an innovative interactive home monitoring program for patients discharged after delivery for pre-eclampsia using an iPad-based home monitoring application with secure video conferencing capabilities and electronic health record data integration, currently in pilot testing.  The purpose of this study is to assess readmission rates in patients participating in our pilot testing as a means of determining feasibility of remote patient monitoring.

Iron Deficiency Anemia in Pregnancy Database

Iron deficiency is the most common pathologic cause of anemia in pregnancy

In order to address this issue, the University of Virginia Health System OB/GYN department implemented an Iron Deficiency Anemia in Pregnancy Treatment Protocol to provide guidelines on the management of care for pregnant women with anemia. We have created a database of pregnant women with iron deficiency anemia to identify whether the treatment protocol improves outcomes for women receiving care at UVA.

NICHD Stillbirth Collaborative Research Network (SCRN) Database

The SCRN investigators attempted to enroll all stillbirths occurring to residents of geographically-defined catchment areas and a representative sample of live births from these areas. Enrollment at the time of delivery was through 59 local hospitals affiliated with the clinical sites, selected to ensure access to at least 90% of all pregnancies ending in stillbirth or live birth to residents of these areas.

Cause of Death Analysis using INCODE Algorithm for Stillborn Deliveries at UVA

INCODE is a cause of death algorithm created by the SCRN researchers to assign a possible or probable cause of death for stillborn deliveries.  The algorithm has been applied to 512 stillbirths (The Stillbirth Collaborative Research Network Writing Group, JAMA, 2011) from the initial SCRN patient population.   Our aim is to assess the utility of this algorithm that has been used to assess the cause of death for stillborn deliveries for the SCRN cohort in the UVa patient population to assess its validity in our patient population.

The Fit for 2 Pilot Study

We are conducting a pilot study to better understand how effective and feasible an exercise intervention among pregnant, obese women is in reducing maternal weight gain during pregnancy and improving maternal markers of metabolic function.  We hypothesize that improved exercise during pregnancy can mitigate excessive weight gain and improve markers for metabolic function among obese, pregnant women.

The Impact of the UVA Enhanced Recovery After Surgery (ERAS) Protocol on Repeat Cesarean Section Pain Score

Enhanced recovery after surgery (ERAS) is a concept that combines various evidence-based aspects of perioperative care to accelerate patient recovery.  At the University of Virginia, The Enhanced Recovery After Surgery (ERAS) for cesarean deliveries protocol was initiated September 2014 at UVA and updated in October of 2017.  Each patient was assessed for many factors, including but not limited to, postoperative pain, the quantity of opioid pain medication utilization, and length of stay in the hospital.

Assessing the Utility of Current Fetal Surveillance Standard of Care in Twin Pregnancies 

We hypothesize that monitoring most twin pregnancies by ultrasound every two weeks does not improve the outcomes of these pregnancies.  We plan to look at all twin pregnancies from 2011-2020 at the University of Virginia.  We will analyze all prenatal surveillance performed to determine how frequently the surveillance leads to an intervention that changes the outcome of the pregnancy.

A Phase 2b/3a Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of AMAG-423, a Digoxin Immune Fab, in Antepartum Subjects with Severe Preeclampsia

Thus far, no studies have definitely identified the cause of severe preeclampsia in pregnant women. One possible reason that has been considered relates to something referred to as “digoxin-like substances,” which circulate in the blood.  These “digoxin-like substances” have some of the same effects as the medicine digoxin.  Digoxin is a drug used to treat heart problems that is toxic if the dose is too high or if too much is taken.  These substances (“digoxin-like substances”) may be causing the elevated blood pressure and possibly other changes that women with preeclampsia go through.  The purpose of this study is to investigate the safety of Digoxin Immune Fab and to see how well it might work to improve symptoms of preeclampsia and improve conditions of prematurity if the baby is born early.

The PEARLE Study: Prospective, Single-Arm, Pivotal Clinical Trial Designed to Assess the Safety and Effectiveness of the JADA Device in Treating Primary Postpartum Hemorrhage

Postpartum hemorrhage (PPH), or excessive blood loss after childbirth, is the leading cause of maternal mortality. Uterine atony, or suboptimal uterine contracts after childbirth, is the most prevalent cause, involved in 75% of primary PPH cases.  This study aims to test a negative pressure PPH device that causes the uterus to collapse into and onto itself, mimicking the natural process following childbirth.

Asymptomatic Bacteriuria in Pregnancy and Test of Cure

The purpose of this study is to analyze and determine the utility of test of cure urine cultures following treatment of pregnant women found to have asymptomatic bacteriuria on screening urine culture. The type of data collected will be demographics (age, race, parity, etc), comorbid medical conditions (hemoglobinopathies, diabetes, etc) and adverse pregnancy outcomes (pyelonephritis, preterm birth, etc) all obtained from a retrospective chart review.

Can we prenatally predict which babies with ureteral dilation/pyelectasis require high-risk referral and treatment soon after delivery?

Our study aims to determine whether we can prenatally predict which mothers need to be followed long-term at a high-risk center to see regression or progression of the dilation of the renal collecting system in utero.  We aim to better understand which patients may need further follow-up or intervention based on associated ultrasonic signs and associated maternal factors. This determination will lower unnecessary follow-up of pyelectasis and help care for the babies that need close monitoring.

Human papillomavirus infection and preeclampsia risk: a retrospective cohort study

There is conflicting evidence as to whether pre-pregnancy infection with human papillomavirus (HPV) increases the risk of preeclampsia during pregnancy. The current study primarily aims to assess the effect of pre-pregnancy HPV infection on preeclampsia/eclampsia risk. Secondary outcomes of interest include assessing for potential effect modification between HPV infection and other genital infection.

 Emergency cesarean delivery and postpartum depression: a retrospective cohort study

Qualitative work has indicated that guilt and self-blame due to having a non-natural delivery was cited as a frequent feeling among women with postnatal distress. Prior quantitative studies have reported conflicting results about the association between mode of delivery and postpartum depression. The current study is a retrospective chart review to assess if emergency cesarean delivery is a risk factor for postpartum depression among women that delivered and were followed up at the University of Virginia Health System.

Time from uterine incision to delivery: Association with 5-minute neonatal AGPAR score

The aim of the Improvement Project was to determine whether shortening time from uterine incision to delivery could improve neonatal APGAR scores among women who have undergone cesarean delivery.  The primary objective of the Improvement Project was to assess the association between time from uterine incision to delivery in a population of women that underwent cesarean delivery at the University of Virginia Health System.

Second-trimester placental volume to predict pregnancy outcomes

Placental weight and other similar measures could serve as a marker for placental insufficiency or reduced maternal blood flow through the placenta.  In this study, we will estimate placental volume during the second trimester (approximately 20 weeks) universal anatomy scan using two-dimensional ultrasonography. This is a chart review study to investigate whether second-trimester placental volume predicts adverse pregnancy outcomes associated with placental insufficiency. 

Proteinuria at term and the diagnosis preeclampsia

A diagnosis of preeclampsia during pregnancy or delivery typically relies on both repeated measurements of elevated blood pressure and elevated urine protein (proteinuria). The urine/protein creatinine ratio quantifies the level of proteinuria and is currently the ideal method utilized in the modern diagnosis of preeclampsia.  Therefore, the current definition of an elevated urine protein/creatinine ratio may lead to the over-diagnosis of preeclampsia and unnecessary changes in clinical practice (e.g. administration of magnesium sulfate, cesarean delivery, etc.) when the diagnosis is made without maternal or fetal benefit, and potentially harmful. We plan to investigate the normal physiologic change in proteinuria at term.

Trends in the management of pregnancies complicated by fetal heart abnormalities

Congenital heart defects are the most common congenital anomalies and occur with an incidence from 0.8-1% live births. Our study aims to better understand how pregnancies complicated by fetal heart abnormalities are managed. Particularly, our study aims to determine whether longer geographic distance increases the rate of cesarean delivery and induction of labor at earlier gestational ages among pregnancies complicated by fetal heart abnormalities.

Fetal Anomalies and Postnatal Outcomes Database

The purpose of the Fetal Anomalies and Postnatal Outcomes Database is to create a central database that stores key information about what fetal anomalies are detected prenatally, how anomalies have been diagnosed, and postnatal outcomes of neonates such as surgical and follow up outcomes. Additionally, the database aims to store pertinent information about pregnancy outcomes and maternal characteristics, which could affect fetal anomalies and postnatal outcomes

A retrospective analysis to identify the optimal treatment for controlling Type II and gestational diabetes in pregnant women

Our goal is to investigate whether there is an added benefit in terms of decreased rates of neonatal outcomes, such as neonatal hypoglycemia, and maternal outcomes when insulin is used in conjunction with oral hypoglycemics compared to using either insulin or oral hypoglycemics alone.

Clinical Outcomes after Implementation of New Hypertension Management Criteria

In 2015, the American College of Obstetrics and Gynecology published new guidelines for the management of hypertension in pregnancy, which were then adapted and implemented at the University of Virginia. The purpose of this project is to evaluate the effect of these new guidelines on patient management, with a primary outcome variable of hospital stay in days.  Secondary outcomes will include clinical outcomes such as blood pressure, anti-hypertensive medication use, and health care utilization measures.

Validating a calculator that will estimate risk of cesarean after an induction of labor with an unfavorable cervix

Prediction models for induction success have previously been limited to nulliparous women and have generally found a favorable starting cervical exam to be the largest driver of success. The University of Pennsylvania School of Medicine developed a calculator that estimates the risk of cesarean after an induction of labor with an unfavorable cervix (Levine LD et al, 2018). We aim to determine if the calculator accurately predicts the risk of cesarean at the University of Virginia.

Short and long-term maternal morbidity associated with mode of preterm delivery

A chart review of women who experienced a preterm birth at the University of Virginia Medical Center is being performed. We will create as a comparison group a group of women who delivered by cesarean after 37 completed weeks gestation during the same time period, matched for age, parity and birth month.  We will then use appropriate statistical techniques to make comparisons between those women who delivered vaginally and those who delivered by cesarean.

Maternal outcomes and management of the third stage of labor in mid-trimester deliveries

Our study examines mid-trimester deliveries, occurring between 14w0d gestation and 23w6d gestation.  Specifically, we plan to perform a retrospective cohort chart review to investigate maternal morbidities associated with the prolonged third stage of labor, defined as greater than 30 minutes, in a population of women delivering in the second trimester in a single institution.  Our study is powered for a primary outcome examining rates of postpartum hemorrhage.  Secondary outcomes will include rates of maternal infection and the need for uterine instrumentation or manual extraction for removal of the placenta.

Medical induction of labor or dilation and evacuation for management of second-trimester pregnancy loss or termination: a retrospective cohort study

The primary aim of this study is to better understand complications associated with D&E and medical induction of labor in order to improve the counseling of patients. The primary objective of the study is to assess the association between D&E and maternal complications compared to medical induction of labor.

Utilization and outcomes of cystoscopy at the time of cesarean delivery

With the advent of almost universal training in cystoscopy in obstetrics and gynecology residency programs, we hypothesize that the use of intraoperative cystoscopy during cesarean delivery is on the rise, without a concomitant rise in the number of urinary tract injuries. In addition, modern trends in other gynecologic surgery such as hysterectomy may lead clinicians to have this practice drift into evaluation during cesarean delivery.  We also hypothesize that increased use of cystoscopy increases operative time and the use of adjunct anesthetics during prolonged surgeries for those undergoing cesarean with neuraxial anesthesia.

Management of morbidly adherent placenta: changes in modern clinical practice and maternal outcomes.

The objective of this retrospective case-control study is to evaluate the maternal and neonatal outcomes of planned cesarean hysterectomy with and without the use of bilateral internal iliac artery balloon occlusion during cesarean hysterectomy at UVA hospital. We hypothesize that maternal outcomes, specifically need for massive transfusion, have improved since the implementation of planned delivery in the hybrid operating room and with use of internal iliac artery balloon occlusion at the time of cesarean hysterectomy and that neonatal outcomes have not changed.

Neonatal outcomes in obese women undergoing cesarean section for fetal heart rate tracing abnormality

We are studying maternal obesity as a risk factor for adverse neonatal outcomes in women undergoing cesarean section with abnormal fetal heart rate tracing.  Additionally, we will determine the association between maternal obesity and length of operative intervals cesarean delivery for abnormal heart rate tracing.

Concordance Between Obstetric Anatomic Ultrasound and Fetal Echocardiography in Diagnosing Congenital Heart Disease

The purpose of this retrospective study is to examine the concordance or discordance between cardiac anomaly diagnoses from routine obstetric ultrasound and dedicated fetal echocardiography in pregnant women who underwent second-trimester ultrasound. These imaging methods will be compared to pediatric echocardiograms to determine which method is most appropriate for antenatal screening.

Fetal hydramnios and delivery interventions: a retrospective cohort study

Fetuses with hydramnios, or the accumulation of excess amniotic fluid in pregnancy, are at a higher risk of complications, including fetal anomalies, preterm birth, cord prolapse, and others.  Hydramnios is usually diagnosed in the third trimester during sonography. Typically, pregnant women with hydramnios undergo additional fetal surveillance, including non-stress testing and biophysical profiles. However, anecdotal evidence suggests that fetal surveillance rarely detects any evidence of fetal compromise and so is not clinically useful. This Quality Improvement project is to determine whether continued fetal surveillance of fetuses with hydramnios (identified during the 20-week anatomy scan) increases the sensitivity of related complications and thus improves/alters pregnancy management.

Routine sonography to assess third-trimester fetal growth in obese women

In general clinical practice, palpation is used to assess fetal growth during the third trimester. However, among obese women, fetal growth cannot be adequately assessed using palpation. As a result, current practice is such that obese women often undergo additional fetal growth sonograms in the third trimester in order to accurately monitor fetal growth. However, anecdotal evidence indicates that additional imaging rarely detects fetal growth abnormalities. Therefore, additional imaging may lead to additional and unnecessary procedures and associated medical costs. The hypothesis of this project is that the use of third-trimester ultrasound to assess fetal growth among obese women does not improve the identification of fetal growth abnormalities in this population.

Initiative to Reduce Number of Vaginal Exams in Laboring Women at Term with SROM

Many studies have established the association between an excessive number of vaginal exams performed and deleterious outcomes in laboring women, such as intra-amniotic infection and intrapartum fever. No trials have yet been conducted to establish the appropriate frequency of cervical exams, and while it is the general consensus of practitioners to perform an exam only if its result will alter the management of labor, often exams are performed when unnecessary clinically. Greater than seven vaginal exams during active labor has been repeatedly cited as a risk factor for developing chorioamnionitis independent of meconium passage and length of labor.

The aim of this quality improvement project is to determine whether tracking the number of cervical exams in this population reduces the number of all exams. Secondarily, we are interested in determining whether a reduced number of cervical exams reduces the incidence of infection.

Antenatal Predictors of NICU Admission at a High-Risk Perinatal Center

This project aims to understand the NICU admission rates based on gestational age, the reason for admission, obstetric antecedents, and other potential contributing factors such as, but not limited to, social determinants of health and mode of delivery.  This will help identify causes of NICU admission rates in order to isolate areas that could be targeted for reduction of admissions.