10 Clinical Trials for Various Conditions
Objective: To study the natural history of normal pregnancy and the most frequent pregnancy complications responsible for the excessive rate of perinatal morbidity and mortality, in order to develop models to predict the occurrence of these complications of pregnancy at the earliest possible time. The study focuses on the prediction of preterm labor with intact membranes, preterm prelabor rupture of membranes (PROM), preeclampsia, small for gestational age, gestational diabetes, and fetal death. These complications account for a minimum of $30 billion annually in the US alone. Study population: A cohort of pregnant women seeking care at the prenatal clinic of the Perinatology Research Branch in Detroit, Michigan. Design: A prospective observational cohort study of the natural history of women with a normal pregnancy, a history of adverse outcome, or those with a complication in the index pregnancy; therefore, this study will include nulliparous and parous women. Data will be collected at the time of clinic visits and will include interviews, clinical measurements, and ultrasound studies. We will assemble a biorepository of maternal biological fluids (blood, urine, saliva, cervicovaginal fluid, gingival crevicular fluid, swabs to characterize microbiota, amniotic fluid when a clinically indicated amniocentesis is performed). Placentas will be collected at the time of delivery as well as umbilical blood, and swabs to characterize the neonatal microbiota. We will use a retrospective case control and case-cohort design to generate models for the prediction of the most common pregnancy complications. These models will be developed by classifying obstetrical complications according to clinical presentation and histologic placental lesions. Models will be developed and subsequently validated in an independent cohort. Outcome measures: The goal is to develop sensitive, specific, and parsimonious predictive models to identify the patients at risk for developing complications of pregnancy using a combination of clinical and biological markers (biochemical and biophysical).
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.
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.
Adding TAP block with Bupivacaine may decrease the use of PCA bolus use after caesarean section for pain relief.
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.
A randomized controlled trial of 1,500 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy.
This is a study evaluating the use of the modified beef tongue model for teaching repair of obstetrical fourth-degree laceration to residents. Participants will be randomized to either an instructional video using the modified beef tongue model or to an instructional workshop using the modified beef tongue model. Primary outcome will be measured as change in technical skills score as measured by change from baseline on a validated objective structured assessment of technical skills (OSTATS) for repair of fourth-degree laceration.
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.
Cesarean delivery has become the most common surgical procedure in the US. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to improve the quality of post-cesarean analgesia and markedly reduce opioid consumption. The effect of NSAIDs on healthy volunteers results in inhibition of platelet aggregation and prolonged bleeding time. However, in the obstetric population, the presence and degree of platelet inhibition after NSAID exposure is less clear. The investigators plan to use Platelet Aggregometry and Thromboelastography (TEG) to evaluate the effect of ketorolac on platelets.
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.