Clinical trials: Antenatal Care
Meconium Aspiration
Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
OBJECTIVES: Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
- Trial name
- NCT00004500
- Testing
- Lucinactant, Standard Care
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- Windtree Therapeutics
Fetal Growth Retardation
Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age
To estimate the percentage of children with serum IGF-1 > 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment.
- Trial name
- NCT00174252
- Testing
- Genotonorm (Somatropin)
- Where
- 22 sites in France
- Volunteers
- 57 people
- Sponsor
- Pfizer
Pregnancy
Maternal Fetal Device Performance Twins
Maternal Fetal Monitoring devices assist the health care professional in acquiring, monitoring, and storing fetal and maternal physiologic data which support clinical decision making for pregnant women and assesses the overall…
- Trial name
- NCT06835647
- Testing
- Investigational Fetal Monitor, Ultrasound Imaging Device
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- GE Healthcare
Premature Rupture of Fetal Membranes
Evaluation of CRB in PROM Patients
The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening Balloon (CRB) for the induction of labor in term and near-term patients with premature rupture of membranes (PROM).
- Trial name
- NCT01736852
- Testing
- CRB, Pitocin
- Where
- 4 sites in United States
- Volunteers
- 129 people
- Sponsor
- Cook Group Incorporated
Pregnancy
Safety and Performance of a Fetal Monitoring System
The objective of this study is to demonstrate the safety and performance of the M•care™ System for use in antenatal monitoring of pregnant women ≥ 32 weeks' gestation.
- Trial name
- M•CARE SE (NCT05294211)
- Testing
- M•care™ System, Cardiotocography (CTG)
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Marani Health
Persistent Pulmonary Hypertension of the Newborn
Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn
This study assessed the safety and treatment effect of intravenous (IV) Remodulin as an add-on therapy in neonates with persistent pulmonary hypertension of the newborn (PPHN).
- Trial name
- NCT02261883
- Testing
- IV Remodulin
- Where
- 14 sites in United States
- Volunteers
- 42 people
- Sponsor
- United Therapeutics
Pulmonary Hypertension, Familial Persistent, of the Newborn
A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.
- Trial name
- NCT01720524
- Testing
- iv sildenafil
- Where
- 42 sites in United States, Belgium and 10 more
- Volunteers
- 59 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Pregnancy
Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability
The specific goal of the proposed research is to develop a reliable, non-invasive fetal and maternal heart rate and contraction monitor that is unaffected by obesity and requires less nursing intervention than the tocodynamometer…
- Trial name
- NCT01400880
- Testing
- Electrode-based Sensor
- Where
- United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Convergent Engineering, Inc.
Fetal Hypoxia, Fetal Distress
Trans-abdominal Fetal Pulse Oximetry
The Raydiant Oximetry Sensing System (Lumerah) is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy.
- Conditions
- Fetal Hypoxia, Fetal Distress, Fetal Acidemia, Fetal or Neonatal Effect of Complication of Labor
- Trial name
- NCT05147584
- Testing
- Dual fetal oxygen sensors
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Raydiant Oximetry, Inc.
Pregnancy, Fetal Monitoring
Use of In-Home Non-Stress Monitoring Device for Fetal Monitoring: A Nonsignificant Risk (NSR) Device Study
This study evaluates the safety and performance of the PregnaOne System, a non-significant risk (NSR) investigational medical device for in-home fetal monitoring in pregnant women during the third trimester.
- Trial name
- NCT07223996
- Testing
- PregnaOne System
- Where
- 3 sites in United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Nestmedic Spolka Akcyjna
Obstetric Labour, Premature
The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor
Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor.
- Trial name
- NCT00404768
- Testing
- GSK221149A
- Where
- 57 sites in United States, Argentina and 9 more
- Volunteers
- 93 people
- Sponsor
- GlaxoSmithKline
Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester
Vscan Access R2 Feasibility Evaluation
This study is being done to evaluate if the Vscan Access R2 Ultrasound System can measure Fetal Heart Rate (FHR) in humans when compared against a reference device (GE Corometrics 170 Series Fetal Monitor), and to gather feedback…
- Trial name
- NCT03617419
- Testing
- GE VScan Access R2 Ultrasound System, GE Corometrics 170 Series Fetal Monitor
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Pregnancy
Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects
This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.
- Trial name
- NCT03504189
- Testing
- PregSense™, Cardiotocopraphy (CTG)
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 151 people
- Sponsor
- Nuvo-Group, Ltd.
Pregnancy
Maternal Fetal Device Performance Singleton
Maternal Fetal Monitoring devices assist the health care professional in acquiring, monitoring, and storing fetal and maternal physiologic data which supports the decision making for pregnant women and the overall fetal health…
- Trial name
- NCT06726343
- Testing
- Fetal Monitoring Device, Investigational Fetal Monitoring Device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- GE Healthcare
Pregnancy; Habitual Aborter, Weeks of Gestation 37 or More
Accuracy and Reliability of Fetal Heart Rate and Uterine Contraction Monitoring Method
Clinical Investigation Protocol for a study designed to determine the equivalence of the Monica AN24 monitor to Philips 50XM for fetal heart rate (FHR) and uterine contraction (UC) monitoring during labor.
- Trial name
- NCT01280357
- Testing
- Monica AN24 (K101081), Philips 50XM
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Monica Healthcare Ltd
Fetal Monitoring
A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepartum Fetal Monitoring
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate and maternal heart rate on pregnant women with a singleton pregnancy, starting from 32 weeks of gestation.
- Trial name
- NST (NCT04915131)
- Testing
- Bloomlife MFM-Pro
- Where
- 2 sites in United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Bloom Technologies
Growth Disorders, Intrauterine Growth Retardation
Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation
- Trial name
- NCT01073605
- Testing
- Genotonorm
- Where
- 31 sites in France
- Volunteers
- 208 people
- Sponsor
- Pfizer
PPHN, Persistent Pulmonary Hypertension of the Newborn
Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN)
Sildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will reduce the need for inhaled nitric oxide.
- Conditions
- PPHN, Persistent Pulmonary Hypertension of the Newborn, Hypoxic Respiratory Failure
- Trial name
- NCT01069861
- Testing
- sildanefil
- Where
- United Kingdom
- Volunteers
- 4 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Persistent Pulmonary Hypertension of the Newborn
Persistent Pulmonary Hypertension of the Newborn
The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a supporting and safe therapy and to evaluate the…
- Trial name
- FUTURE 4 (NCT01389856)
- Testing
- Bosentan
- Volunteers
- 23 people
- Sponsor
- Actelion
Fetal and Neonatal Alloimmune Thrombocytopenia
Phase 2 Study on the Pharmacokinetics and Safety of RLYB212 in Pregnant Women at Higher Risk for HPA-1a Alloimmunization
The purpose of this Phase 2 study is to assess the pharmacokinetics (PK) and safety of RLYB212 in HPA-1b/b pregnant women at higher risk for HPA-1a alloimmunization and FNAIT.
- Trial name
- NCT06435845
- Testing
- Anti-(integrin beta-3) human monoclonal antibody
- Where
- 3 sites in Netherlands, Norway and 1 more
- Volunteers
- 1 people
- Sponsor
- Rallybio