[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pre-term-birth\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pre-term-birth":93},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100536174","better-birth-outcomes-through-technology-education-and-reporting-100536174",false,"NCT06261398","Better Birth Outcomes Through Technology, Education, and Reporting","Better Birth Outcomes and Experiences Through Technology, Education, and Reporting (BETTER)","BETTER","Inclusion Criteria\n\n* Less than 20 weeks and 6 days pregnant upon enrollment\n* At least 18 years of age\n* Receiving obstetric care at OSU McCampbell Hall or OSU Outpatient Care East\n* Singleton pregnancy and fetus with a heartbeat\n* English speaking\n* Able to receive text messages\n\nExclusion Criteria\n\n* Has a significant medical condition (eg sickle cell disease) that is a cause of anemia\n* Has a plan for transfusion during pregnancy","FEMALE","18 Years",{"count":20,"type":21},550,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a pragmatic randomized control trial to evaluate the BETTER intervention compared to standard obstetrical care (control) to determine whether it helps to reduce maternal anemia and other adverse pregnancy outcomes. The BETTER intervention includes one motivational interviewing session and bi-weekly text messages to encourage patients to connect with resources that address their social needs, including housing, food, and transportation. Quantitative data will be used to study participant outcomes, including surveys, and electronic health record data.",[27,28,29,30],"Pregnancy","Maternal Anemia","Pre-Term Birth","Hypertensive Disorders",[32,27,33,34,35],"Social Determinants of Health (SDoH)","Patient portals","Patient engagement","Disparities","RECRUITING","2026-06-05",{"date":39,"type":40},"2026-06-09","ACTUAL",{"date":42,"type":40},"2024-02-26",{"date":44,"type":21},"2028-03",{"name":46,"class":47},"Ohio State University","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100567492","phase-1-comparing-the-pharmacokinetics-of-a-progesterone-ring-versus-a-progesterone-vaginal-insert-100567492","NCT06668896","Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert","An Open-Label, Four-Treatment, Parallel Study of the Comparative Pharmacokinetics of a Progesterone Intravaginal Ring (IVR) 8 mg and 12 mg\u002FDay Versus Progesterone Vaginal Insert 100mg","Inclusion Criteria:\n\n* Individuals assigned female at birth who are post-menopausal, women 40 to 65 years of age, inclusive. Postmenopausal is defined as 6-months of spontaneous amenorrhea with serum FSH levels \\> 40 mIU\u002FmL (if not taking systemic hormone therapy) or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.\n* Able and willing to correctly and independently complete all study procedures.\n* Able to read, understand, and provide written informed consent after the nature of the study has been fully explained and must be willing to comply with all study requirements and procedures.\n* VA vaginal pH of ≤ 5.0. Women with vaginal atrophy may rescreen at least 6 weeks after starting either systemic or topical estradiol therapy.\n* Women who are taking systemic (e.g. oral, injectable, transdermal) progesterone (P4) therapy must have at least 2 weeks of wash out from the last dose prior to visit 2.\n\nExclusion Criteria:\n\n* Subjects with clinically significant chronic kidney disease defined as Glomerular Filtration Rate of \\\u003C60 mL\u002Fmin\u002F1.73m2\n* Subjects with uninvestigated hematuria\n* Subjects with known nephrolithiasis, known polycystic kidney disease (PKD), or other known renal genetic disorders\n* Subjects with prior pelvic malignancies requiring radiation therapy, or whose surgery for such has led to complications such as fistulas, etc.\n* Subjects with a history of any severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or study treatment administration or could interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into the trial. This includes but is not limited to the following:\n\n  * Active chronic hepatitis B or hepatitis C infection including hepatitis B surface antigen and hepatitis C antigen positive patients with or without abnormal liver enzymes\n  * Concurrent neurodegenerative disease\n  * Cardiovascular: uncontrolled hypertension, unstable angina, myocardial infarction or symptomatic congestive heart failure within the past 6 months or serious uncontrolled cardiac arrhythmia or use of Class 1 antiarrhythmic\n  * Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol\n* Subjects with hypersensitivity toward any ingredients in the study treatments.\n* Participation in any other investigational drug or device trial in which administration of an investigational study drug\u002Fdevice occurred within 30 days or placement of a non-drug eluting medical device within 15 days prior to the Screening Visit (Visit 1). This does not include re-enrollments into this study, who require at least 14 days of washout prior to re-enrollment.",true,"40 Years","65 Years",{"count":59,"type":21},60,[61],"PHASE1","This study is looking for healthy female adults to use an vaginal ring with differing amounts of the hormone progesterone and go through a series of blood draws to measure how much progesterone is in the body following the use of these vaginal rings over an extended period of time.",[64],"Pre Term Birth",[66],"normal healthy","NOT_YET_RECRUITING","2026-05-07",{"date":70,"type":40},"2026-05-08",{"date":72,"type":21},"2026-09",{"date":74,"type":21},"2028-04",{"name":76,"class":77},"Daré Bioscience, Inc.","INDUSTRY",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100618902","phase-2-efficacy-and-safety-of-aspirin-and-lansoprazole-for-prevention-of-preterm-birth-in-high-risk-pregnant-women-a-biomarker-enriched-trial-100618902","NCT07337655","Efficacy and Safety of Aspirin and Lansoprazole for Prevention of Preterm Birth in High-Risk Pregnant Women: A Biomarker-Enriched Trial","A Phase II\u002FIII Clinical Trial Evaluating the Efficacy and Safety of Aspirin and Lansoprazole in High-Risk Pregnant Women for the Prevention of Preterm Birth: A Biomarker-Enriched Design","Inclusion Criteria:\n\n* Age: 18 to 45 years at the time of informed consent.\n* Pregnancy: Singleton intrauterine pregnancy confirmed by ultrasound.\n* Gestational Age: Between 12+0 and 16+6 weeks' gestation at randomization, based on first- or early second-trimester ultrasound dating.\n* Risk Status: At increased risk for spontaneous preterm birth, defined by at least one of the following:\n* Prior spontaneous preterm birth (\\\u003C37 weeks),\n* History of second-trimester pregnancy loss related to cervical insufficiency,\n* Short cervical length (≤25 mm) identified per site standard prior to randomization,\n* Other clinically significant risk factors for spontaneous preterm birth as determined by the investigator.\n* Biomarker Enrichment: Positive preterm birth risk classification based on serum protein signature and\u002For digital-twin immunologic profile, as defined in the protocol.\n* General Health: In otherwise stable health, with medical conditions related to pregnancy risk permitted if well controlled.\n* Informed Consent: Ability and willingness to provide written informed consent and comply with study procedures.\n* Access to Care: Willingness to receive routine obstetric care at a participating study site and comply with follow-up through delivery and postpartum.\n\nExclusion Criteria:\n\n1. Hypersensitivity \u002F Contraindications\n\n   * Known hypersensitivity, allergy, or intolerance to aspirin, other salicylates, lansoprazole, or other proton pump inhibitors (PPIs).\n   * History of aspirin-exacerbated respiratory disease (AERD), including asthma, nasal polyps, or bronchospasm triggered by aspirin or other NSAIDs.\n   * History of anaphylaxis or severe hypersensitivity to any component of the study drugs.\n2. Hematologic \u002F Bleeding Risk\n\n   * History of major gastrointestinal bleeding, peptic ulcer hemorrhage, intracranial hemorrhage, or other serious bleeding disorder.\n   * Known coagulopathy (e.g., hemophilia, von Willebrand disease) or platelet disorder relevant to aspirin use.\n   * Platelet count \\\u003C100,000\u002FµL at screening.\n   * Hemoglobin \\\u003C8.0 g\u002FdL at screening.\n   * Current or anticipated need for full-dose anticoagulation (e.g., therapeutic low-molecular-weight heparin) or dual antiplatelet therapy during pregnancy.\n3. Gastrointestinal \u002F Hepatic \u002F Renal\n\n   * Active peptic ulcer disease, erosive esophagitis, or known upper GI lesion at significant risk for bleeding, not adequately treated.\n   * History of recurrent peptic ulcer bleeding or perforation.\n   * Documented cirrhosis or clinically significant chronic liver disease (e.g., Child-Pugh B or C).\n   * Renal impairment, defined as Creatinine greater than 1.0 mg\u002FdL, or currently on dialysis.\n   * Known inflammatory bowel disease with recent moderate-severe flare (e.g., requiring steroids or hospitalization in the last 3 months).\n4. Cardiovascular \u002F Blood Pressure\n\n   * Persistent severe hypertension at screening (e.g., ≥160\u002F110 mmHg on repeated measurements) not adequately controlled on therapy.\n   * Known significant structural heart disease or cardiomyopathy that, in the investigator's opinion, would increase risk with trial participation.\n5. Pregnancy-Related \u002F Obstetric\n\n   * Multiple gestation (twins or higher-order).\n   * Known major fetal structural anomaly or chromosomal abnormality at screening (if results already available).\n   * Active preterm labor, preterm premature rupture of membranes (PPROM), or cervical dilation requiring emergent intervention at time of screening.\n   * Placenta previa with active bleeding or high risk of bleeding where aspirin is contraindicated.\n   * Planned elective termination of pregnancy.\n   * Current or planned participation in an obstetric intervention that would make outcome attribution to the investigational regimen impossible (per investigator judgment).\n6. Concomitant Medication Constraints (incl. CYP considerations)\n\n   * Chronic daily use of aspirin \\>81 mg\u002Fday or other antiplatelet\u002FNSAID therapy that cannot be discontinued or adjusted to comply with the protocol.\n   * Current use of any PPI or H₂ blocker that cannot be safely discontinued or switched per protocol prior to randomization.\n   * Concomitant use of medications with a very narrow therapeutic index that are strong CYP2C19 or CYP3A4 substrates and for which modest PK changes could pose significant risk (e.g., selected anticonvulsants, calcineurin inhibitors, or antiarrhythmics), where dose adjustment or close monitoring is not feasible.\n   * Use of another investigational drug or device within 30 days prior to screening, or planned during the trial, that could affect maternal or fetal outcomes.\n7. Other Medical Conditions\n\n   * Any malignancy requiring active systemic therapy during pregnancy.\n   * Uncontrolled autoimmune, rheumatologic, or hematologic disease that, in the opinion of the investigator, significantly increases risk with aspirin or PPI therapy.\n   * Poorly controlled diabetes with significant end-organ complications (e.g., advanced nephropathy, proliferative retinopathy) where participation would add undue risk.\n   * Any severe or unstable systemic illness (e.g., decompensated heart failure, severe pulmonary hypertension) that, in the investigator's judgment, makes trial participation unsafe.\n8. Substance Use \u002F Adherence\n\n   * Active substance use disorder (alcohol or drugs) likely to interfere with adherence, follow-up, or maternal\u002Ffetal safety.\n   * Any condition (including significant psychiatric illness or cognitive impairment) that, in the investigator's opinion, would compromise informed consent, adherence to study procedures, or reliable follow-up.\n9. Study Conduct \u002F Ethical Considerations\n\n   * Concurrent participation in another interventional clinical trial impacting maternal-fetal outcomes.\n   * Prior randomization in this trial during the current pregnancy.\n   * Any other reason that, in the investigator's judgment, makes the participant unsuitable for the trial or at increased risk such that participation would not be in their best interest.","45 Years",{"count":87,"type":21},670,[89,90],"PHASE2","PHASE3","This protocol describes a seamless Phase II\u002FIII, randomized, double-blind clinical trial evaluating the efficacy and safety of daily low-dose aspirin (81 mg) plus lansoprazole (30 mg) in pregnant individuals at high risk for preterm birth when compared to existing standard of care, identified through biomarker-enriched screening. Participants will be enrolled between 12-16+6 weeks' gestation and followed through delivery and postpartum. The primary objective is to determine whether the investigational combination reduces the incidence of preterm birth before 37 weeks of gestation compared with placebo.",[93],"Pre-term Birth","2026-01-12",{"date":96,"type":40},"2026-01-13",{"date":98,"type":21},"2026-10-01",{"date":100,"type":21},"2032-09-30",{"name":102,"class":47},"Stanford University",1]