Phase 3 N=465 PREGNANT Short Cervix Trial
Preterm Delivery · Short Cervix · Short Uterine Cervical Length
Primary: Number of Participants With Birth <=32 6/7 Weeks Gestation. — 36; 21 participants — p=0.020
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N/A N=385 Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix
Preterm Birth
Primary: Spontaneous Delivery Before 34 Completed Weeks — 51; 12 Participants
N/A N=20 Cervix Monitor for Elasticity and Length Measurements
Preterm Birth
Primary: Cervix Elasticity — 54; 19.7 kPa
N/A N=200 Cervical Length and Bishop Score in Preinduction Cervical Assessment Prior to Induction of Labor
Cervical Dystocia
Primary: Cervical Length Prior to Labor Induction — 2.9; 3 centimetres
N/A N=150 Sweeping the Membranes, Cervical Length and Duration of Labor
Disorder of Amniotic Cavity and/or Membrane
Primary: Cervical Shortening — 27.45; 29.61; 23.30; 23.88 millimeters
Phase 3 N=1,311 A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix
Short Cervical Length
Primary: Number of Participants With Delivery or Fetal Loss of Either Twin Prior to 35 Weeks Gestation — 84; 84; 86 Participants
N/A N=80 Modifying Cervical Bishop Scoring System
Failed Induction of Labor
Primary: Area Under Receiver Operating Characteristic Curve (ROC) for Modified Bishop Score — 0.916 probability — p=0.000
N/A N=53 Multifactorial Approach to Emergent Cerclage
Cervical Insufficiency
Primary: Gestational Latency Achieved Between Cerclage Placement and Time of Delivery — 80; 97 days — p=0.018
N/A N=30 Sound Check-Correlation Between Transperineal and Digital Cervical Exam in 3rd Trimester Pregnancy
Cervix; Pregnancy
Primary: Correlation of Cervical Dilation Via Butterfly iQ Pocket Ultrasound in Centimeters — 5.1; 5 centimeters — p=.0001
N/A N=57 Assessing Gestational Age in First Trimester Pregnancies Using Ultrasound
Pregnancy Early
Primary: Can Both Transabdominal Ultrasounds See a Gestational Sac and Yolk Sac or Embryo? — 51 Participants
N/A N=45 Coherence Imaging of the Cervical Epithelium With Scanning a/LCI
Cervical Dysplasia
Primary: Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies — 90.3; 100.0 percentage of correct…
Phase 2 N=271 Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
Preterm Birth
Primary: Number of Participants Not Giving Birth Before Week 32 and Week 34 of Gestation — 73; 71; 67; 66 Participants
N/A N=122 Prevention of Preterm Birth With a Pessary in Singleton Gestations
Preterm Birth · Short Cervix
Primary: Number of Subjects Experiencing Preterm Birth — 26; 23 Participants
N/A N=55 Coherence Imaging of the Cervical Epithelium
Cervical Epithelia
Primary: Number of Patients With Interferometric Data Acquired From Cervical Epithelium — 3; 41 patients
N/A N=42 DilaCheck Cervical Dilation Measurement Trial
Cervical Dilation · Labor Pain · Labor Fast
Primary: Interexaminer Agreement — 9; 4 Participants
Phase 4 N=236 Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial
Obesity · Labor Induction · Cesarean Delivery
Primary: Number of Participants With a Need for Cesarean Delivery — 51; 53 Participants
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=46 Prevention of Preterm Birth With a Pessary in Twin Gestations
Premature Birth · Short Cervix
Primary: Number of Participants With Preterm Delivery — 9; 8 Participants
N/A N=90 Automated Fetal Femur Length Measurement by Five-Dimensional Ultrasound
Automated Fetal Femur Length Measurement by Five-Dimensional Ultrasound
Primary: Gestational Age Calculated by Accurate Dates of the Last Menstrual Period — 35.6 weeks
N/A N=204 Cervical Ripening With a Double-lumen Balloon Catheter for Six Versus Twelve Hours
Induction of Labor Affected Fetus / Newborn
Primary: Time From Foley Bulb Placement to Time of Delivery. — 24.2; 24.57 hr — p=0.8
N/A N=230 Cervical Ripening in Premature Rupture of Membranes
Pregnancy · Premature Rupture of Membranes · Preterm Premature Rupture of Membranes
Primary: Rate of Cesarean Section — 27; 26; 89; 86 participants — p=0.99
N/A N=180 Laminaria Compared to Dilapan-S for Cervical Preparation Before Dilation and Evacuation at 18-24 Weeks of Gestation
Second Trimester Abortion
Primary: D&E Procedure Time — 7.35; 7.55 minutes
N/A N=5 Randomized Clinical Trial: Expectant Management vs Laser Treatment of Monochorionic Twins With Severe Selective Intrauterine Growth Retardation and Absent or Reverse Diastolic Flow in the Umbilical Artery
Intrauterine Growth Retardation
Primary: Survival — 100; 100 percentage of AGA babies who survived
N/A N=168 Short Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure
Cesarean Section Complications
Primary: Cesarean Scar Defect in the Uterine Incisional Line — 12; 39 participants — p=0.0001
N/A N=813 Third Trimester Screening of Fetal Growth Restriction
Fetal Growth Retardation · Fetal; Slow Growth
Primary: Rate of Small for Gestational Age at Birth Identified Antenatally — 28; 46 Participants
N/A N=72 Dilapan Versus Laminaria
Cervical Preparation
Primary: Procedure Time — 5.9; 8.1 minutes
N/A N=270 Ultrasound Guided Catheter Length Survivability
Catheter Complications
Primary: Duration of IV Survival — 92; 136 hours
N/A N=32 Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion
Abortion, Second Trimester
Primary: Procedure Time — 22.4; 22.6 minutes
N/A N=60 Severing Nuchal Cord at the Time of Delivery.
Perinatal Outcome
Primary: Umbilical Cord pH — 7.29; 7.32 pH — p=0.1
Phase 3 N=5,060 Randomized Clinical Trial on Clinical Management of ASCUS and LSIL (ALTS)
Cervical Intraepithelial Neoplasia
Primary: Percentage of Participants With Cervical Intraepithelial Neoplasia III (CIN III) — 10.93; 10.25; 10.84 percentage of participants