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Search Results within category "Pregnancy, Prenatal & Childbirth"

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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
Female
18 Years and over
NA
This study is also accepting healthy volunteers
NCT03047161
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Inclusion Criteria:

• 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
Exclusion Criteria:

• 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
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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.
Kara Hoppe
Female
12 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT02299414
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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
• Retinopathy
• 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
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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.
Jacquelyn Adams
Female
18 Years and over
Early Phase 1
This study is also accepting healthy volunteers
NCT04478942
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Inclusion Criteria:

• 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
Exclusion Criteria:

• 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
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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
All
2 Years to 10 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04085523
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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
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Obstetric Liposomal Bupivacaine Via Surgical Transversus Abdominis Plane Block for Post Cesarean Pain Control (OBLiBupi)

This study seeks to identify whether the addition of liposomal bupivacaine to regular bupivacaine and saline administered via surgical transversus abdominis plane (TAP) block will reduce the cumulative opioid dose in the first 48 hours after cesarean. 60 women scheduled for cesarean at Unity-Point Health Meriter Hospital in Madison, Wisconsin will be enrolled and can be expect to be on study for up to 6 weeks post-partum.
Kathleen Antony, MD
Female
18 Years and over
Phase 4
This study is also accepting healthy volunteers
NCT04897841
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Inclusion Criteria:

• Maternal age greater than or equal to 18
• Singleton or multifetal pregnancy
• Able to receive neuraxial analgesia
• Planned/ scheduled Cesarean delivery OR non-urgent Cesarean delivery at UnityPoint-Health Meriter with adequate time to consider and consent to the study
• Able to provide consent in English
Exclusion Criteria:

• Known hypersensitivity to bupivacaine or liposomal bupivacaine (defined as a history of a reaction or allergy to bupivacaine (injectable, intravenous, or transdermal) reported by patient or documented in the medical record) or patient report
• Plan by the obstetrical provider to inject bupivacaine or other local anesthetic into the cesarean incision due to potential differences in pain levels.
• Contraindication to regional analgesia
• Positive urine drug screen at admission to the hospital, if ordered for clinical purposes.
• Current opioid use or opioid use disorder per patient report or documented in the medical record or the Enhanced Prescription Drug Monitoring Program (ePDMP) (reviewed by Principal Investigator 1-14 days prior to surgery)
• Chronic opioid use or opioid use disorder, either patient reported or documented in the medical record or the ePDMP (reviewed by PI 1-14 days prior to surgery), defined as opioid use on most days for greater than 3 months
• Planned Cesarean hysterectomy (excluded due to anticipated blood loss and alternative pain control measures, possible prolonged intubation)
• Planned vertical midline incision
• Presence of renal dysfunction precluding the use of non-steroidal anti-inflammatory drugs (NSAIDs)
• Ischemic heart disease, congestive heart failure, or cardiomyopathy of pregnancy
• Coagulopathy
• Planned discharge from the hospital less than 48 hours postpartum
Pain, unspecified, Cesarean Section Complications, Pain, Opioid Use
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