104 Clinical Trials for Various Conditions
The goal of this clinical trial is to learn if a personalized prenatal support program \[(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond, (PTBCARE+)\] works to lower stress and lower the risk of early delivery in pregnant individuals at high-risk for delivering preterm. The main question\[s\] it aims to answer are: * Does the PTBCARE+ patient support program lower patient-reported stress levels during pregnancy? * Does the PTBCARE+ patient support program improve biologic measures of stress during pregnancy? * Does the PTBCARE+ patient support program result in a higher chance of delivering a healthy baby at or close to full term? Researchers will compare people who participate in the PTBCARE+ patient support program to those receive usual care to see if the PTBCARE+ patient support program lowers patient-reported stress, improves biologic measures of stress, and increases the chance of delivering a healthy baby at or close to full term. Participants will be randomly assigned to receive the PTBCARE+ patient support program or usual prenatal care. All participants will be asked to: * complete 2 study visits during pregnancy - including completing electronic surveys, providing a blood and urine sample, measuring the heart rate variability by a clip or the ear or finger, and body composition evaluation using a simple scale-like device. * complete one study visit postpartum that includes completing electronic surveys, and measuring heart rate variability. Blood and urine sample collection and body composition evaluation via InBody scale are optional at the postpartum visit. People who are randomly assigned to receive the PTBCARE+ support program will receive several resources to help them during pregnancy. These things include items such as: * a stress reduction toolkit; * access to an online website that can also be downloaded as a smart phone app; * the option to receive an electronic massage while in clinic, and more. * additional support gifts provided at routine clinical appointments People who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.
The purpose of this research study is to use serial magnetic resonance imaging (MRI) to define the timing and factors associated with brain injury as well as the pattern of brain growth of very preterm infants during hospitalization in the neonatal intensive care unit (NICU). In addition, the goal is to utilize early MRI to risk-stratify preterm infants and tailor rehabilitative interventions according to risk in order to explore associations between NICU rehabilitative intervention and short- and long-term outcomes of preterm infants.
This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive standard of care preoperative antibiotics (excluding azithromycin). The primary endpoint is a maternal infection composite defined as any one of the following up to 6 weeks postpartum: endometritis, wound infection, abscess, septic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection.
This is a multi-center, randomized single-blind nonsurgical trial conducted in approximately 216 primiparous postpartum women at high risk for prolonged/sustained pelvic floor disorders with symptomatic, bothersome urinary incontinence (UI) amenable to nonsurgical treatment. TULIP is a 3-Arm trial with two active interventions (Arms 1 and 2) and a Patient Education control arm (Arm 3). Arm 1 consists of pelvic floor muscle training (PFMT). Arm 2 uses a home biofeedback device (leva®). The primary outcome will be assessed at 6 months postpartum by blinded outcomes assessors, and follow-up will continue until 12 months postpartum.
The goal of this observational study is to develop and validate cell-free RNA-based biomarkers for predicting a variety of adverse pregnancy outcomes in a pregnant person population. The main question it aims to answer are: 1. Can cell-free RNA-based biomarkers predict which pregnant people are at greatest risk of developing adverse pregnancy outcomes (e.g., preterm birth, preeclampsia)? 2. What is the performance of such biomarkers when predicting an adverse pregnancy outcome (e.g., sensitivity, specificity, PPV, NPV, TPR)?
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.
More than 80% of the 3 million women who labor and deliver each year in the United States undergo continuous electronic fetal monitoring (EFM) during labor in order to fetal hypoxia and prevent the transition to acidemia, expedited operative delivery, and/or neonatal morbidity. Category II EFM is the most commonly observed group of fetal heart rate features in labor. One common response to Category II EFM is maternal oxygen (O2) supplementation. The theoretic rationale for O2 administration is that it increases O2 transfer to a hypoxic fetus. There are conflicting national guidelines regarding O2 administration - the American College of Obstetricians and Gynecologists suggest O2 is ineffective, whereas the Association of Women's Health, Obstetric, and Neonatal Nurses recommend continued use given lack of definitive data on safety and efficacy. A recent national survey of nearly 600 Labor \& Delivery providers in February 2022 revealed that 49% still use O2 . Thus, there remains equipoise on the topic and high-quality data on the safety of intrapartum O2 is needed. None of the trials to date have studied the effect of intrapartum O2 on important clinical measures of neonatal or maternal morbidity. This safety data is imperative because the field of obstetrics must hold supplemental O2 to the same rigorous standards applied to any drug used in pregnancy. Without data on these definitive outcomes, it will be challenging to implement evidence-based recommendations for supplemental O2 use on Labor \& Delivery. The investigators will conduct a large, multicenter, randomized noninferiority trial of O2 supplementation versus room air in patients with Category II EFM in labor.
A recent randomized controlled trial by Cluver et al included 180 women with preterm pre-eclampsia between 26+0 to 31+6 weeks' gestation undergoing expectant management: 90 were randomised to extended release metformin and 90 to placebo. Investigators found that extended release metformin (3g daily) can prolong gestation in women with preterm pre-eclampsia. Combination metformin and esomeprazole has shown promise in the treatment of preeclampsia as both agents reduce placental and endothelial secretion of soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin, and reduce endothelial dysfunction.
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 aim of the study is to assess the efficacy and safety of an innovative two-hand (hand forceps) fetal head extraction technique during the transverse cesarean sections (LTCS) by comparing with the conventional one-hand technique used worldwide for centuries. The primary research question of the study is whether two-hand fetal head extraction technique results in quicker head delivery. The secondary research question is whether two-hand technique would cause increased incidence of extension of uterine incision as well as other adverse events while compared to conventional one-hand technique. Our hypothesis is that two-hand technique would speed up fetal head delivery without increasing the risk of extension of uterine incision as well as other adverse events, in the meantime, maternal discomfort will be significantly reduced since fundal pressure will not be required during the fetal head delivery.
Pregnant women who are at risk of delivering their infants in the periviable period can suffer a large amount of stress and anxiety. Moreover, many women feel a loss of control over their own pregnancy. There is some evidence that more counseling and planning can help reduce maternal stress and anxiety. Patients at risk of delivering in the periviable period will be randomized to either receive standard counselling or to complete the periviable birth plan.
This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or within 6 months preceding conception. Pregnancy-related data, potential confounding factors and information related to pregnancy outcome will be collected. The schedule of office visits and all treatment regimens will be determined by the treating healthcare provider. Duration of the study is 10 years, at minimum.
This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery. Subjects are randomized to Materna Prep Device or Standard of Care without use of the Materna Prep Device Intervention with the Materna Prep Device is expected to be a one-time use of approximately 30-90 minutes during the 1st stage of labor. Subject participation in the study is targeted to be 12 months from the time of the use of the device during delivery.
Aim 1: Assess the effectiveness of the Prevena Incision Management System in decreasing postoperative surgical site infections in the obese parturient undergoing non-emergent cesarean delivery. Aim 2: Assess patient satisfaction after using the Prevena Incision Management System following a non-emergent cesarean delivery. Our overall long term goal is to reduce morbidity and incidence of surgical site infection (SSI) in obese parturient who undergo non-emergent cesarean delivery.
This study is to determine if using a standardized debrief checklist after vaginal delivery improves communication between the vaginal delivery health care team members and if using the checklist increases a sense of enhanced communication between team members.
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.
Wound complications after Cesarean section (C-section) are common in obese women. Approximately 25% of obese women having a C-section will have a wound complication. This research study is designed to assess whether applying a source of vacuum (suction) to the wound can reduce the risk of wound complications. The investigators plan to enroll 220 women into the study. Women will be randomly selected to receive standard stitching and stapling of the incision (cut on the abdomen) or closure with stitches, staples and wound suction. Subjects will be seen for follow-up visits in 7-14 days and again at 4-6 weeks after surgery. The number of wound complications in each group will be compared. If the wound suction technique is successful in preventing wound complications, this may substantially reduce pain and suffering in a large number of women undergoing C-section for delivery.
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.
Adding TAP block with Bupivacaine may decrease the use of PCA bolus use after caesarean section for pain relief.
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 control after cesarean delivery is associated with improved breastfeeding and infant rooming-in times. In addition, inadequate analgesia leads to elevated plasma catecholamine concentrations, which negatively affect every organ system. There is growing evidence that ketamine, N-methyl-D-aspartate receptor antagonist, is efficacious when used as an adjuvant in postoperative pain control. A 2006 Cochrane Collaboration systemic review and meta-analysis concluded, "Ketamine in subanesthetic doses....is effective in reducing morphine requirements in the first 24 hours after surgery." Ketamine's prolonged analgesic effect, despite its short half-life and its use in low doses, is theorized to be due to blockade of spinal cord central sensitization. Central sensitization is a phenomenon whereby repeated painful stimulus leads to more severe pain perception over time despite no change in the intensity of the painful stimulus.Ketamine may also prevent the development of acute opioid tolerance. Ketamine's analgesic effects have also demonstrated in the obstetric population. Post-cesarean delivery morphine requirements in women who received ketamine as part of a general anesthesia technique were decreased. Similary, low-dose ketamine in conjunction with bupivacaine-only spinal anesthesia reduced postoperative analgesic requirements compared to bupivacaine-only spinal anesthesia and bupivacaine-fentanyl spinal anesthesia. In the United States, healthy women scheduled for elective cesarean delivery commonly receive spinal anesthesia with bupivacaine-fentanyl-morphine. To our knowledge, IV ketamine has not been studied as an adjuvant to this regimen in the analgesic management in post-cesarean delivery patients. Multimodal therapy for postoperative pain control is widely practiced due to the advantage it provides in blocking multiple pain pathways while minimizing side effects of each individual pain medication. We hypothesize that low dose intravenous ketamine will improve multi-modal post-cesarean analgesia compared to placebo. The purpose of this study is to evaluate this hypothesis and study the possible side effects of this regimen in combination with bupivacaine-fentanyl-morphine spinal anesthesia.
The investigators aim to show that single use negative pressure dressings can decrease the rate of wound complications in obese women (BMI \> 40 kg/m2) undergoing cesarean delivery at a tertiary medical center by randomizing women to receive either a single use negative pressure dressing or the standard dressing after cesarean delivery.
This is a phase-III multi-center double-blind randomized clinical trial of 1,800 individuals with a history of prior preterm birth at less than 35 weeks gestation who are randomized to either 162 mg aspirin or 81 mg aspirin daily. The study drug will be initiated between 10 and 15 weeks gestation and continued through 36 weeks, 6 days gestation. The primary endpoint is recurrent preterm delivery or fetal death prior to 35 weeks, 0 days gestation.
20 high-risk parent-infant dyads hospitalized in a 58-bed level IV NICU will be randomized to either receive Telehealth or in-person Baby Bridge services. Baby Bridge is a program to bridge the gap between NICU discharge and initiation of community-based early intervention services. Weekly therapy services are provided in the child's home, either via telehealth or in-person. An in-person evaluation in the NICU is attempted for each child prior to NICU discharge. Cost, adoptability, feasibility, adaptations, and acceptability amongst caregivers will be compared between the two groups.
This is a two-group randomized controlled trial conducted at five hospitals across the U.S. designed to test the effectiveness of an Integrated infectious diseases/Substance Use Disorder outpatient clinic (IC) compared to treatment as usual aimed at reducing infection related readmissions and improving health outcomes in people hospitalized with an infection related to injecting opioids or stimulants.
This is a randomized controlled trial to assess the effect of routine exercise counseling compared to the recommendation for postprandial ambulation on infant birthweight among pregnant people with gestational diabetes mellitus. The primary outcome is birthweight percentile for gestational age at delivery. Secondary outcomes include feasibility and acceptability, need for metformin or insulin for glycemic control, mode of delivery, neonatal hypoglycemia. Participants will be counseled to either complete 20 minutes of walking after meals, or be counseled with routine exercise counseling of 30 minutes of low-impact 5x a week. Their activity will be tracked by "FitBit" pedometers and uploaded via bluetooth to a database for review. They will continue to receive routine obstetric and diabetes care.
The goal of this clinical trial is to compare medications in women having a cesarean delivery. The main question it aims to answer are: • Which medication is better to use as a first-line prevention agent for nausea and vomiting Participants will rate their nausea, pain and other symptoms after surgery Researchers will compare two drugs, ondansetron and dexamethasone to see if the side effects of pain medications are improved after cesarean.
Background: There is scarce literature investigating how patients dispose of unused opioid supplies after their cesarean postoperative pain has faded. The Office of the Surgeon General has identified research on the prevention of opioid use disorder area as well as research on the management of pain as a "Surgeon General Priority" that needs urgent investigation. Hypothesis: At least 33% of postpartum women discharged home with an opioid prescription and a drug deactivation pouch will use the pouch to dispose of remaining opioids within 30 days of delivery. Methods: This is a prospective single arm interventional pilot study.
The purpose of this research is to study serious clinical problems from surgical pain and the use of oxycodone or other opioids in women having a Cesarean Delivery to improve the safety and efficacy of surgical pain relief. This research will ultimately improve the safety and efficacy of surgical pain relief with opioids by preoperative risk predictions and personalized care with the right dose of the right analgesic for each patient.
Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality worldwide. Up to 80% of PPH is caused by uterine atony, the failure of the uterine smooth muscle to contract and compress the uterine vasculature after delivery. Laboratory and epidemiological studies show that low extracellular and serum calcium levels, respectively, decrease uterine contractility. A pilot study performed by the investigators supports the hypothesis that intravenous calcium chloride is well tolerated and may have utility in preventing uterine atony. The proposed research will establish the relationship between uterine tone and calcium through a clinical trial with an incorporated pharmacokinetic and pharmacodynamic (PK/PD) study. In a randomized, placebo-controlled, double-blind trial, investigators will establish the effect of 1 gram of intravenous calcium chloride upon quantitative blood loss and uterine tone during cesarean delivery in parturients with high risk of uterine atony. Investigators will concurrently collect serial venous blood samples to measure calcium for PK/PD modeling in this pregnant study cohort. High-quality clinical research and development of novel therapeutics to manage uterine atony are critical to reduce the high maternal morbidity and mortality from PPH.