Our current research studies pertaining to expectant mothers are listed below.
TXA
The Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean Delivery: A RCT (TXA) study is a randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery.
PREVENA
Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean: A Multicenter RCT (PREVENA)
PROSPECT
A trial of Pessary and Progesterone for Preterm Prevenion in Twin Gestation With a Short Cervix (PROSPECT).
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. The purpose of this research study is to find out whether pessary or vaginal progesterone lowers the risk of babies being born preterm to women who are pregnant with twins and have a short cervix. A pessary is a round, soft silicone device that goes around the cervix. Progesterone is a hormone naturally produced by the placenta.
OFFSITE II
The purpose of Outpatient Foley For Starting Induction of Labor at TErm (OFFSITE Study II) in Nulliparous Women: A Randomized-Controlled Study is to determine if preparing your cervix (the opening of your uterus) for labor induction (labor started with the use of medicine or a procedure) prior to your hospital admission reduces the time you have to spend in the hospital before having your baby. One out of every four women has induction of labor because labor does not naturally start on its own. In many women who are induced, the cervix is not ready for labor. At UAB, as part of standard of care, when the participant is admitted to Labor and Delivery, a Foley catheter (a narrow tube with a small balloon on the end) is inserted into the cervix to help it open. Once in place, it usually takes about 12 hours before the catheter comes out, and cervix is ready for labor.
PreMOD
Premature Infants Receiving Milking or Delayed Cord Clamping: Randomized Controlled Multicenter Non-Inferiority Trial (PREMOD) is a study being done to find out whether umbilical cord milking (UCM) is at least as good as or better than delayed cord clamping (DCC) to reduce bleeding in the brain or prevent death in premature newborns. The investigators will study short and long term outcomes of infants delivered before 32 weeks gestation that receive either UCM or DCC. * The trial was stopped by the DSMB for safety in the small strata. They subsequently allowed for continuation of the trial in infants 29-32+6 wk GA.
TOPS
A Randomized trial of Pessary in Singleton Pregnancies with a Short Cervix (TOPS) (Multicenter Maternal Fetal medicine Units Network)
The purpose of this research study is to find out whether a pessary lowers the risk of a baby being born too soon to women with a short cervix. One study has been done to date in the US to find out if placing a pessary in women with a short cervix helps the pregnancy to last longer. A pessary is a soft silicone device that goes around the cervix. The Arabin pessary has not been approved by the FDA for treating pregnant women who have a short cervix and are at risk for preterm delivery. Participants will be in the study from between 16-23 weeks of pregnancy until one month after the expected date of delivery or until the baby is discharged from the hospital, whichever is the longest.
PEARLE
Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage (PEARLE)
CHAP
The Chronic Hypertension and Pregnancy (CHAP) Project is a study that will evaluate the safety and benefits of treating chronic hypertension (CHTN) during pregnancy. CHTN is high blood pressure that occurs before pregnancy or during the first half of pregnancy and persists after pregnancy. CHTN is strongly associated with a number of bad outcomes for mothers and babies including preeclampsia (high blood pressure or worsening blood pressure in the second half of pregnancy), abruption (placental separation causing bleeding), preterm birth and small for gestational age babies (inadequate fetal growth). It is also is associated with rare bad outcomes such as stroke and death. It is unclear whether or not all pregnant women with CHTN should be treated with BP medicines. We do not know if using or not using BP medicine to treat pregnant women with known mild CHTN during pregnancy affects outcomes for mothers and babies. There is some concern that BP medicines may reduce the blood flow to the baby and cause poor fetal growth. Therefore, we are conducting this study to find out whether treating pregnant women with mild CHTN with medicines to lower their blood pressure below 140/90 is safe and beneficial for the mother and baby.
MOMPOD
Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD)
Because of the lack of convincing data on the safety and effectiveness of metformin to treat type 2 diabetes in pregnancy and the high likelihood that women on metformin will need supplemental insulin, the purpose of this study is to assess the safety and effectiveness of metformin added to insulin to treat type 2 diabetes in pregnancy. Compared to using insulin alone, we are testing to see if adding metformin to insulin treatment reduces your chances of having complications with your baby. Pregnant women with type 2 diabetes have an increased risk for delivering a large baby, a baby who has medical problems including low blood sugar at birth, and/or a baby that may be injured during birth due to his/her size. The participant’s doctor will discuss these potential complications with you.
FRITO
The Association of Maternal Body Fat Distribution with Abnormal Labor, Cesarean Delivery, and Perinatal Outcomes in Women with Severe Obesity with Body Mass Index ≥ 40 kg/m2 (FRITO)
This research study will evaluate the relationship between fat distribution (measured in a late third trimester obstetric visit by trained personnel by ultrasound for fat depth, skin fold thicknesses, circumferences) and abnormal labor with need for cesarean delivery. We will also evaluate the relationship of body fat distribution to adverse outcomes to both the mother and the child.
SLEEP
A Randomized Trial of Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy (SLEEP)
Sleep apnea is a common sleep disorder in which you have one or more pauses in breathing or shallow breaths while you sleep. Continuous Positive Airway Pressure (CPAP) is a treatment that uses mild air pressure to keep the airways open during sleep. It consists of a mask that fits over the nose and/or mouth. Hypertensive disorders of pregnancy are diagnosed when a woman has high blood pressure and possibly other signs that her organ systems are not working normally. One of these signs is proteinuria (an abnormal amount of protein in the urine). It is not clear why some women develop a hypertensive disorder during pregnancy. Gestational diabetes is diagnosed when a woman has high blood sugar during pregnancy. Women with gestational diabetes have to make changes in their diet and/or start medications to help control their blood sugar levels. The purpose of this study is to understand how CPAP for sleep apnea may affect hypertensive disorders of pregnancy and other complications of pregnancy such as gestational diabetes.