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Suggestions within category "Pregnancy, Prenatal & Childbirth"
5 Study Matches
Electrophysiology of Fetal Arrhythmia (fMCG)
Fetal research and clinical practice has been hampered by a lack of suitable investigational techniques. Currently, ultrasound is the only widely used method of studying fetal anatomy and physiology, but it has significant limitations for assessment of cardiac rhythm. The proposed study will allow the investigators to evaluate fetal magnetocardiography (fMCG) as a new tool for the study of normal and abnormal fetal heart rate and rhythm.
Ronald Wakai, PhD
18 Years and over
• uncomplicated pregnancy at gestational age >12 weeks
• pregnancy complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm at gestational age >15 weeks
• uncomplicated pregnancy <12 weeks gestation
• pregnancy complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm at gestational age <15 weeks
Fetal Arrhythmia, Supervision of high risk pregnancy, Healthy Volunteers
Chronic Hypertension and Pregnancy (CHAP) Project (CHAP)
The purpose of this study is to evaluate whether a blood pressure treatment strategy during pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults (<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP is severe) is effective and safe.
12 Years and over
Inclusion Criteria:1. Women with chronic hypertension in pregnancy with new or untreated chronic hypertension, blood pressure 140-159 systolic or 90-104 diastolic OR known chronic hypertension on monotherapy and taking any antihypertensive and blood pressure ≤159/104 (including those with blood pressure <140/90); 2. Singleton; and 3. viable pregnancy <23 weeks of gestation.
Exclusion Criteria:1. Blood pressures prior to randomization ≥160 systolic or ≥105 diastolic (with or without treatment); 2. Patients currently treated with >1 antihypertensive medication (more likely to have severe chronic hypertension); 3. Multi-fetal pregnancy; 4. Known secondary cause of chronic hypertension; 5. High-risk co-morbidities for which treatment may be indicated:
• Class C or higher diabetes mellitus
• Chronic kidney disease
•including baseline proteinuria (>300mg/24-hr, p/c ratio >0.3, or persistent 1+ proteinuria*) or creatinine >1.2. *If a dipstick value at screening is more than trace, a clean catch or catheter urine should be obtained and re-tested by dipstick. If this shows trace or absence of protein, the patient is included. If it again shows 1+ protein, the patient is excluded until a 24-hr urine <300mg/24hr or p/c ratio is <0.3.
• Cardiac disorders: cardiomyopathy, angina, CAD
• Prior stroke
• Sickle cell disease; 6. Known major fetal anomaly; 7. Known fetal demise; 8. Suspected IUGR; 9. Membrane rupture or planned termination prior to randomization; 10. Plan to deliver outside the consortium centers (unless approved by the Clinical Coordinating Center) or unlikely to follow-up in the opinion of study staff or previous participation in this trial; 11. Contraindication to labetalol or nifedipine (e.g. know hypersensitivity); and (12) Current substance abuse or addiction (cocaine, methamphetamine) *The minimum age varies by center
Hypertension, Pre-existing hypertension complicating pregnancy, childbirth and the puerperium
PROMMO Trial: Oral Misoprostol vs IV Oxytocin (PROMMO)
This is a prospective, randomized trial looking at the ideal method of labor induction for women with prelabor rupture of membranes and an unfavorable cervical Bishop score. The study will compare oral misoprostol and intravenous oxytocin.
18 Years and over
Early Phase 1
• Early Term to late term pregnancy (>37 weeks and 0 days and <42 weeks and 0 days)
• Late Preterm Pregnancy (34 weeks and 0 days and <37 weeks)
• Confirmed rupture of membranes by either sterile speculum exam or AmniSure
• Simplified Bishop Score ≤ 6
• Maternal Age > 18 years old
• Singleton gestation
• Appropriate gestational age dating by certain LMP or ultrasound performed prior to 20 weeks gestational age
• Concern for intra-amniotic infection
• Previous Cesarean delivery
• Lack of appropriate dating criteria for the pregnancy
• Inability to give informed consent in the patient's native language
• Known bleeding disorder such as von Willebrand's disease or hemophilia
• Anticoagulation administration within 24 hours of delivery
Premature Rupture of Membrane, Induction of Labor Affected Fetus / Newborn, Premature rupture of membranes
A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of TransCon CNP Administered Once Weekly in Prepubertal Children With Achondroplasia
The trial is a multicenter, double-blind, randomized, placebo-controlled, dose escalation trial of weekly TransCon CNP administered subcutaneously in prepubertal children 2 to 10 years old, inclusive, with Achondroplasia.
Janet Legare, MD
2 Years to 10 Years old
Inclusion Criteria:1. Clinical diagnosis of ACH with genetic confirmation 2. Age between 2 to 10 years old (inclusive) at Screening Visit 3. Prepubertal (Stage 1 breasts for girls or testicular volume < 4ml for boys) at Screening Visit 4. Able to stand without assistance 5. Caregiver willing and able to administer subcutaneous injections of study drug
Exclusion Criteria:1. Clinically significant findings at Screening that:
• are expected to require surgical intervention during participation in the trial or
• are musculoskeletal in nature, such as Salter-Harris fractures and severe hip pain or
• otherwise are considered by investigator or Medical Monitor/Medical Expert to make a participant unfit to receive study drug or undergo trial related procedures 2. Have received treatment (>3 months) of human growth hormone (hGH) or other medications known to affect stature or body proportionality at any time 3. Have received any dose of medications intended to affect stature or body proportionality within the previous 6 months of Screening Visit 4. Have received any study drug or device intended to affect stature or body proportionality at any time 5. History or presence of injury or disease of the growth plate(s), other than Achondroplasia, that affects growth potential of long bones
Achondroplasia, Disorders of newborn related to slow fetal growth and fetal malnutrition
Placental Lesions in Fetal Growth Restrictions
The purpose of this research study is to develop imaging methods to diagnose placental injury in pregnancies diagnosed with fetal growth restriction (FGR). Investigators are doing this research because the use of IV iron, followed by a Magnetic resonance imaging (MRI), may help detect injury in the placenta. The IV iron, ferumoxytol, is an iron preparation used for treatment of iron deficiency anemia. It is given in hospital setting under close medical attention. Ferumoxytol(FE) is FDA approved for some uses, but in pregnant women, its use as a MRI contrast is investigational.
Dinesh Shah, MD
18 Years to 50 Years old
Early Phase 1
• Pregravid Body Mass Index (BMI) 18.5-39.9 kg/M2
• Women with singleton pregnancies
• Ultrasound confirmed pregnancy dating prior to 14 weeks gestation
• Gestational age of 27 0/7
•32 6/7 weeks at FGR diagnosis based on standard clinical criteria: Either estimated fetal weight (EFW) less than 10 percentile OR abdominal circumference less than 10th percentile
• Diagnosis of preeclampsia at FGR diagnosis
• Gestational Diabetes Mellitus or type I/II Diabetes Mellitus
• Known fetal chromosome abnormality, structural malformation or syndromes in current pregnancy
• Known fetal viral infection syndrome
• Alcohol/drug use in current pregnancy
• History of sickle cell anemia, sickle cell trait or other inherited anemia with risk of iron overload
• Contraindications to MRI (such as claustrophobia, metallic implant, etc.) based on MRI Screening
• Participation in other interventional clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
• Any physical or psychological symptom, based on the clinical judgment of the study physician that would make a participant unsuitable for the study.
Maternal care for other conditions predominantly related to pregnancy, Pregnancy, Prenatal & Childbirth, Women's Health/OB-GYN, Fetal Growth Retardation