N/A N=35 Refinement of the OBMedical LaborView System
Fetal Monitoring
Primary: Fetal Heart Rate With the Laborview System Versus the CTG Monitor - Pilot Comparison Study — 5.282 beats per minute — p=<.1
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=30 Comparison of SureCALL® Labor Monitor® and Tocodynamometer Measurement in Preterm and Term Pregnant Women
Pregnancy
Primary: Comparison of SureCALL® and Tocodynamometer Detection of Contraction Event Timing — 0.99 Seconds — p=0.4901
N/A N=20 Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement (IUPC) Measurement in Pregnant Women
Pregnancy - Labor Monitoring
Primary: Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC — -0.73; -1.74 Seconds — p=.04627
N/A N=11,108 Fetal ST Segment and T Wave Analysis in Labor
Pregnancy · Obstetric Labor · Parturition
Primary: Number of Participants With Primary Composite Outcome — 52; 40 Participants — p=0.20
N/A N=584 Transperineal Ultrasound to Assess the Progress of Labour
Placenta Praevia · Vaginismus
Primary: Caesarean Delivery — 79 Participants
N/A N=65 Continuous Non-Invasive Measurement of Hemoglobin During Parturition
Hemorrhage · Cesarean Section
Primary: Pearson Correlation Coefficient for Hemoglobin Measurements — 0.6 Correlation Coeficient
N/A N=48 Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring Device
Contraction
Primary: Continuity in Readings of Contractions — 0; 0 Number of minutes — p=0.75
N/A N=30 Maternal Fetal Device Performance Singleton
Pregnancy
Primary: Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Investigational Devices on Subjects Enrolled in Each Gestational Age Group — 85.01; 92.27…
Early Phase 1 N=103 Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability
Pregnancy
Primary: Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC — 2.98; 3.95 seconds
N/A N=20 Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring Patients by Practicing Clinicians
Pregnancy - Labor Monitoring
Primary: Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers — 1.47; 0.85 Odds Ratio — p=0.0093
N/A N=70 Feasibility and Acceptability of the Combination of Propess and AN24 Monica for Outpatient Labour Induction (PRAM)
Intrapartum Fetal Monitoring · Pregnancy
Primary: Feasibility Defined as the Number of Eligible Women Who Are Successfully Monitored Remotely With Trans-abdominal Fetal Electrocardiogram (ECG) Monitoring Device (Monica…
N/A N=71 Electrode-Based Sensor for Non-Invasive Fetal Heart Rate Monitoring With Improved Reliability
Laboring Women With Ultrasound and FSE Monitoring
Primary: Fetal Heart Rate Interpretability — 83.4; 62.4 percentage of time the signals are inter
N/A N=201 LaPPS: Labor Podcast for Patient Satisfaction
Labor Onset and Length Abnormalities · Pregnancy Related
Primary: Labor Agentry Scale — 57; 54 score on a scale
N/A N=202 Pregnancy-Related Hypertension: Adherence to a New Type of Monitoring
Gestational Hypertension · Preeclampsia · Chronic Hypertension With Pre-Eclampsia Complicating Childbirth
Primary: Adherence to the American College of Obstetricians and Gynecologists Guideline of Postpartum Blood Pressure Check Within 10 Days Postpartum — 59; 89 Participants…
N/A N=55 Postpartum Hypertension: Remote Patient Monitoring
Hypertension, Pregnancy-Induced
Primary: Aim 1: Number of Participants Enrolled — 55 Participants
N/A N=121 A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepartum Fetal Monitoring
Fetal Monitoring
Primary: Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate — -5.46; -5.57; 6.04; 6.04 BPM
N/A N=20 Cervix Monitor for Elasticity and Length Measurements
Preterm Birth
Primary: Cervix Elasticity — 54; 19.7 kPa
N/A N=34 Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension
Anesthesia, Epidural · Hypotension
Primary: Time-to-treatment of Hypotension (Minutes) — 21.8; 23.1 minutes
N/A N=110 Ultrasound Prediction of Prolonged Labour
Prolonged Labor
Primary: Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound — 81; 76; 80; 76 percentage probability — p=<0.01
N/A N=120 Safety and Performance of a Fetal Monitoring System
Pregnancy
Primary: Fetal Heart Rate (FHR) — 140.1; 140.0 BPM
N/A N=60 Accuracy and Reliability of Fetal Heart Rate and Uterine Contraction Monitoring Method
Pregnancy; Habitual Aborter · Weeks of Gestation 37 or More
Primary: The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM — 84.85 Positive percantage agreement (PPA)
N/A N=60 Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring
High Risk Pregnancy
Primary: Number of Interpretable Results (Participants Who Used the NST Device Correctly) — 107; 1 Remote NST's Completed — p=.1
N/A N=1,607 Monitoring and Testing of Blood Pressure in Postpartum Women
Hypertension
Primary: Median Number of Remote Blood Pressure (rBPM) Measurements Obtained Per Participant — 6 Number of rBPM measurements
Phase 4 N=46 Transcutaneous Electrical Nerve Stimulation for Pain Relief During the Active Phase of Labor
Pain
Primary: Classification of Pain During Labor by Visual Analogue Scale — 57.0; 72.1 mm — p=0.01
N/A N=151 Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects
Pregnancy
Primary: Fetal Heart Rate — 140.3; 140.4 bpm
N/A N=10 Demonstration of a New Device to Measure the Force of Delivering a Baby
Full Term Singleton Pregnancy
Primary: Force Exerted on a Fetus as the Delivery Occurs — 274.5 ounces
N/A N=206 Remote Surveillance of Postpartum Hypertension
Hypertension in Pregnancy
Primary: Number of Participants Whose Blood Pressure Was Assessed in the First Ten Days Following Discharge — 45; 95 Participants
N/A N=305 Evaluation of the Effects of Different Positions Given During Antenatal Electro-Fetal Monitoring
Fetal Monitoring · Patient Comfort · Maternal Health
Primary: Right Side Lying Post NST (3) — 113.67; 108.16; 112.80 mmHg
N/A N=49 Quantitative End Tidal CO2 Monitoring in the Delivery Room (DR)
Delivery Room Resuscitation
Primary: PCO2 Level Outside of Desired Range (40-60 mmHg) — 9; 8 participants
N/A N=197 Foley Bulb Traction for Cervical Ripening
Cervical Ripening · Induction of Labor
Primary: Time to Delivery — 19.8; 18.8 hours