44 Clinical Trials for Various Conditions
The goal of this randomized controlled trial is determine if education on common events in labor in nulliparous women can reduce the postpartum traumatic symptoms. The main question it aims to answer are: * Does prenatal education on labor events reduce post-traumatic symptoms, as measured by thePost Traumatic Stress Disorder Cecklist for Diagnostic and Statistical Manual for Mental Health Disorders (PCL-5) at 6 weeks postpartum? * Does prenatal education on labor affect labor outcomes? Participants will be given surveys: * At enrollment on mental health and previous traumatic experiences * After education on expectations on childbirth * After delivery on experience of childbirth * At 6 weeks and 6 months postpartum on traumatic symptoms and mental health outcomes. They will also have the option to participate in collection of discarded cerebrospinal fluid, blood and serum and physiologic sensitivity testing.
The goal of the proposed research is to test the comparative effectiveness of AIM safety bundles for post-partum women delivered in-person vs. via text/phone to improve early detection of and timely care for complications during the first six weeks postpartum for women experiencing significant health disparities.
The purpose of this study is to compare two complex, multi-component evidence-based postpartum interventions in underserved populations of lower socioeconomic status in an effort to reduce maternal morbidity and mortality.
The purpose of this investigator-initiated randomized control trial is to determine whether oral Nifedipine versus oral Labetalol is superior in controlling high blood pressures in the postpartum period.
This is a hybrid type 1 non-inferiority implementation effectiveness trial among postpartum patients with hypertension (N=1536) that will test the hypothesis that RI-SPHERES (a technologically enabled collaborative care model) is non-inferior to a standard self-measured blood pressure program in terms of persistent hypertension at six weeks postpartum and preventive care receipt within one year of delivery.
To better understand postpartum blood pressure changes, we are proposing a study to monitor blood pressure after delivery in 100 patients who we expect to have normal blood pressure (i.e. low-risk group), 100 patients who we expect to be at risk of new-onset high blood pressure postpartum (i.e. intermediate-risk group), and 100 patients who had high blood pressure prior to pregnancy (or very early, before 20 weeks in pregnancy) who we know are at high risk of blood-pressure related complications postpartum (i.e. high-risk group). Patients will be given a non-invasive wearable device that monitors blood pressure continuously for 6 weeks postpartum. We expect that the daily changes in blood pressure will be different between these groups, which may allow us to better predict who is at risk, how much monitoring is needed, and when to intervene before the blood pressure abnormalities cause complications. The blood pressure device that will be given to patients is the YHE® BP Doctor Med Blood Pressure Smartwatch. This is a highly-accurate medical grade device that has not received FDA clearance. As such, the device is not being used to make blood pressure management and treatment decisions, but rather to gather data on postpartum cardiovascular physiology. Safety stops are built into the protocol such that elevated readings detected by the watch will trigger clinical referrals and validation by standard blood pressure cuffs prior to determine need for treatment.
Postpartum infection if a major cause of maternal morbidity and mortality and surgical site infections are some of the common complications following cesarean section. This study aims to determine the effect of Steri3X on the incidence of cesarean section SSI at Regional One Hospital.
Pain and anxiety are the most common complications after cesarean birth, and impair the mother's ability to optimally care for herself and her newborn. It is important for health care providers to evaluate options post-operatively to maximize symptom management and quality of care for these patients, including the option of complementary therapies such as Healing Touch (HT). This study examines the effects of HT after cesarean delivers , including the differences between pain (Numeric Rating Scale) and anxiety (Numeric Rating scale) through a Randomized Control Trial study design. The total sample size for the proposed study will include 160 participants. The study will include patients' age ≥18 years. Based on their randomization, the study coordinator at each site will schedule either 1) a Healing Touch (HT) practitioner for the intervention group OR 2) a non-HT practitioner who will collect data for the control group. HT practitioner will verify consent, then ask the woman to complete baseline measurements of pain and anxiety. Levels of pain and anxiety will be reassessed post-intervention.
The purpose of this study is to test whether or not activity restrictions after a cesarean section are warranted and if exercise can improve postpartum wellness. This research study is being done because there is no science-based evidence to support postpartum activity restrictions after cesarean sections. Participants will be randomly placed into one of the following study groups: * Standard postpartum and post-operative instructions group: activity restrictions, including no strenuous exercise, sexual intercourse, or lifting objects greater than 25 pounds for 6 weeks or until evaluation at the 6 week postpartum visit * Study group: Structured 10 week exercise protocol consisting of core strengthening exercises (concentrating on the abdominal, gluteal, and pelvic areas), breathing exercises, and diaphragm exercises.
The purpose of the study is to determine the feasibility of placing the levonorgestrel-releasing intrauterine system (LNG - IUS, Mirena®) post-delivery. The investigators will gain information about complications at the time of placement; the investigators will also examine the expulsion rate, side effects, bleeding patterns and subject satisfaction at various time periods after insertion.
Multivitamin/multimineral supplements (MVI) provide important nutrition supplement to the diet of pregnant women to cover potential deficiencies and optimize nutrition status of both mom and baby, especially when the diet is suboptimal or nutrient demand is high while absorption is hindered by various factors such as genetic variance and gastrointestinal function. It is, however, largely unknown whether using an MVI during the lactating period helps improve nutrition status of mom and baby. In this double-blind, randomized, controlled trial, the investigators will recruit 7- postpartum women who exclusively breastfeed at week 5 postpartum and randomly assign them to either receive the Ritual MVI which is commercially available or a blank placebo for 10 weeks. A blank placebo is appropriate because there is currently no recommendation or scientific consensus that lactating women who are healthy and eat a normal diet would have improved nutrition status or maternal-infant health outcomes from a nutrition supplement. The investigators will collect blood and breastmilk samples at baseline and end of the study to assess nutrient status. The investigators hypothesize that consumption of a Ritual MVI leads to better nutrition status and biomarkers in maternal-child dyads compared to control.
The purpose of this study is to determine the normal hemoglobin curve during cesarean delivery and for the first 24 hours after surgery to aid in the creation of an algorithm to detect life-threatening bleeding earlier.
This trial is a pilot-scale, single institution randomized, placebo-controlled trial to assess the feasibility, acceptability, and efficacy of administering dapagliflozin for cardiovascular risk reduction in the postpartum period. The target population is patients at high risk of adverse cardiovascular outcomes within five years post-delivery. Eligible participants will be randomized to receive either: 1) dapagliflozin (10mg daily) for six months (DAPA group) or 2) an orally administered, daily placebo (Control group). The study hypothesizes: The dapagliflozin group will have higher cardiovascular risk reduction scores than the Control Group.
The objective of this research project is to conduct a single-site pilot trial within our institution's clinical remote blood pressures (BP) management program to assess the feasibility and effect of tight blood pressure control versus usual care in the immediate postpartum period after a hypertensive disorder of pregnancy (HDP). The investigators' central hypothesis is that tight blood pressure control will be feasible and acceptable to postpartum individuals and will result in lower BP at six months postpartum and a reduction in postpartum hospital readmissions. Subjects will undergo 3 study visits (1 in-person and 2 remote) involving BP measurements, blood draws, and/or questionnaires. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.
This trial will be a comparative pragmatic open label feasibility randomized controlled trial of oral daily versus IV iron in anemic postpartum patients. Two randomly assigned groups will be compared during the postpartum period: 1. Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks TID. IV placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride. 2. IV Iron group: Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride. 2.1 Oral placebo will be given by mouth for a total of 6 weeks TID.
The purpose of this study is to determine if NT-BNP levels obtained at time of admission for delivery are predictive of intrapartum or postpartum complications in patients with adult congenital heart disease.
The investigators plan to enroll women with PE prospectively to evaluate incremental cardiovascular risk in those who have PE with severe features. This study includes detailed echocardiographic evaluation at several time points. With the current proposal, the investigators aim to collect blood to evaluate several biomarkers to determine if there is a correlation with short and medium-term cardiovascular risk. This opens the door to earlier detection, treatment and improved cardiovascular outcomes.
A clinical study to evaluate safety, tolerability and efficacy of oral administration of ganaxolone in women with postpartum depression
This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of Ganaxolone in Women with Postpartum Depression
In this randomized, double-blind control trial to evaluate the effect of ketorolac given at the time of cord clamp has on estimated blood loss and postcesarean pain control. Patients will be randomized to either placebo or ketorolac prior to surgery. Those randomized to ketorolac will receive ketorolac at cord clamp and three additional doses every 6 hours (total 4 doses/24 hours). Those in the placebo group will receive normal saline during those time periods. Our primary outcome is to assess whether intra-operative ketorolac increases the estimated blood loss during Cesarean delivery.
A highly effective single rod contraceptive implant is now available for use in the US. Delays in the insertion of the device until later in the postpartum period may negatively impact initiation rates. The objective of this study is to compare outcomes of early postpartum insertion (prior to postpartum hospital discharge) of the etonogestrel-releasing contraceptive implant with routine postpartum insertion at 4-8 weeks after delivery. Primary outcome of interest will be time to lactogenesis. Secondary outcomes will include rates of breastfeeding supplementation, infant growth, vaginal bleeding patterns, incidence of side effects, time to resume sexual intercourse after delivery, and incidence of missed routine postpartum follow-up. In addition, a subset of patients who randomize to early postpartum insertion will have expressed breastmilk ascertained for nutrient composition.
The purpose of this study is to examine components of the coagulation system in women undergoing postpartum hysterectomy and to compare laboratory parameters of coagulation in these women to women at increased risk for a postpartum hysterectomy, but who do not have postpartum hemorrhage and a postpartum hysterectomy. During normal pregnancy, the hemostatic balance tips toward hypercoagulation. Non-obstetric surgical blood loss is associated with increased coagulation activity. We have observed that women undergoing a postpartum hysterectomy become hypocoagulable secondary to a consumptive coagulopathy and/or excessive fibrinolysis. This coagulopathy may lead to the administration of multiple blood products. Worldwide, postpartum hemorrhage is a leading cause of maternal death. Plasma levels of tissue plasminogen activator, urokinase plasminogen activator and their inhibitors increase during pregnancy. During labor and delivery activation of coagulation occurs with consumption of platelets, coagulation factors and inhibitors. Obstetric complications during delivery can excessively activate the coagulation system and disseminated intravascular coagulation may ensue. Current treatment for postpartum coagulopathy is non-specific and primarily consists of replacing blood components. If specific causes or markers of abnormal coagulation can be identified in women at risk, then it might be possible to target (with specific medications) specific abnormalities early in the process and decrease hemorrhage and the need for blood transfusions.
This study is undertaken to find out whether prophylactic antibiotics can decrease the infection rate in third and fourth degree perineal tear repairs done in the immediate postpartum period.
The purpose of this study is to assess the health and wellbeing of pregnant and recently pregnant women during the COVID-19 pandemic using an online survey.
Calcium is a life saving medicine in the care of parturients. It has many important uses including treatment of hypocalcemia, treatment of magnesium toxicity, prevention of hypocalcemia during blood transfusion (of citrate containing blood products), treatment of hyperkalemia, and others. Recent clinical trials also suggest that calcium given after cord clamping may decrease blood loss in patients undergoing cesarean delivery. 2 FDA approved forms of calcium can be given intravenously: calcium chloride and calcium gluconate. Over the last decade there have been times with drug shortages of either calcium chloride or calcium gluconate. So there have been and likely will continue to be times when one formulation or the other may not be adequately available. Despite the importance of calcium and the frequency in which it is used in parturients, there are no published studies in parturients to determine dose equivalence between calcium gluconate and calcium chloride. In this study the investigators will determine the population pharmacokinetics of calcium gluconate and calcium chloride in parturients and calculate the dose equivalent ratio the two drugs. This will help clinicians select appropriate doses of calcium and provide resilience to the drug supply chain in our era of frequent drug shortages.
Oxytocin is the first-line drug to promote contraction of the uterus and prevent atony immediately after delivery. Nonetheless, unpredictable uterine atony refractory to oxytocin affects roughly 250,000 parturients annually in the U.S. and rates are increasing. This two-part study will measure the action of oxytocin at cesarean delivery. The first part will measure the pharmacokinetics of a single intravenous (IV) dose of deuterium-labeled oxytocin. The second part will measure the pharmacodynamics of all plasma oxytocin to see how concentrations correspond to the contractile effect on the uterus. After delivery of the fetus, study subjects will receive a bolus of IV deuterated oxytocin followed by an unlabeled oxytocin infusion. Venous blood samples drawn at multiple time points (within 1 hour after delivery) will be analyzed for plasma concentrations of labeled and unlabeled (endogenous + exogenous infused) oxytocin over time. Plasma concentrations will be compared with 0-10 uterine tone scores measuring uterine contraction strength, to describe the concentration-effect relationship. The goal of this study is to define both the pharmacokinetics and pharmacodynamics of oxytocin in parturients to help identify the cause(s) of failed first-line oxytocin therapy.
This study will enroll women planning to have an intrauterine device (IUD) placed for contraception immediately following a vaginal delivery. Women will be randomized to have this procedure done with or without ultrasound guidance. We intend to determine if the routine use of ultrasound to confirm device position reduces the rates of IUD expulsion.
The goal of this study is to identify whether antibiotics given at the time of placement of an intrauterine balloon tamponade (IBT) will result in reduction of the risk of endometritis. The investigators hypothesize that antibiotics given at the time of intrauterine balloon tamponade will reduce the likelihood of postpartum endometritis.
Postpartum hemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and the primary cause of nearly one quarter of all maternal deaths globally. Estimates of blood loss at delivery are notoriously inaccurate, with under-estimation more common than over-estimation. Traditionally, the surgeon performing the cesarean section would estimate the blood loss by visually assessing the blood collected in the surgical drape and counting the number of lap sponges used thru out the procedure. The investigators would like to study and validate an FDA approved device called the gauss Triton device used to estimate blood loss during scheduled cesarean sections.
This study is looking at the relationship between experiences during pregnancy and cardiovascular health 2 to 3½ years later. The investigators are recruiting women from the approximately 10,000 women who were enrolled and followed over the course of their first pregnancy in another study.