Baseline data on neonatal encephalopathy and epilepsy before the introduction of the care bundle

Baseline data on neonatal encephalopathy and epilepsy after the introduction of the care bundle

Neonatal Encephalopathy

Epilepsy

Newborn Morbidity

Intra-partum care bundle invoking 4 elements

Institute of Obstetrics and Gynaecology

Bangalore Medical College

Calicut Medical College

Sudhin Thayyil

Prevention of Epilepsy by Reducing Neonatal Encephalopathy

Two of more unprovoked seizures at least 24 hours apart

Moderate or severe neonatal encephalopathy

Definite or probable seizures as per ILAE classification

Significant basal ganglia, cortical or white matter injury

Thayyil, Sudhin

University College, London

University of Oxford

University of Manchester

Madras Medical College

Bangalore Medical College and Research Institute

Government Medical College, Kozhikode

Magnetic resonance biomarkers will be quantified masked to the interventional group

Women already receiving a pessary in addition to the standard progesterone through the TOPS trial will undergo ultrasound imaging and cervical speculum examination for information collection.

Women already receiving the standard progesterone only will undergo ultrasound imaging and cervical speculum examination for information collection.

Preterm Birth

This standard of care procedure is being done for research purposes and used to collect information and measure the maternal and fetal anatomy.

Ultrasound imaging

This standard of care procedure is being done for research purposes and used to collect tissue and measure the strength and stiffness of cervix.

Cervical speculum examination

Columbia University Medical Center

Mechanical Environment Pregnancy With Short Cervix

Quantifying the Mechanical Environment of Pregnancy Complicated With a Short Cervix With Ultrasound Imaging and Aspiration - Ancillary Study to the Trial of Pessary in Singleton Pregnancies Trial

The mechanical compliance index of the cervix is the percentage of the cervical tissue above a 1.2 stretch threshold under a uniform IUP. This index is calculated using finite element computational methods, given the maternal anatomy and cervical stiffness measured from the aspiration tool. The mechanical compliance index of the cervix will be measured at both time points within the study timeframe, and the change of the mechanical compliance index between the two time points will be assessed. The main outcome parameter will be the mechanical compliance index at the baseline time point, and the other two outcome measures will be used as validation data points.

The investigator will tally the number of women who receive Intervention of Pessary and experience spontaneous preterm birth

Kristin Myers

Associate Professor of Mechanical Engineering

Columbia University

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

The two arms are not randomized under this sub study but carried over from the existing TOPS trial.

Pelvic Organ Prolapse

Gabapentin

placebo

Department of Obstetrics and Gynecology, Mount Sinai Hospital

Gabapentin Reduces Opioid Use Postoperatively ("GROUP Study")

Gabapentin Reduces Opioid Use Postoperatively ("GROUP Study"): A Randomized Control Trial in Women Undergoing Reconstructive Pelvic Surgery

Danny Lovatsis

Mount Sinai Hospital, Canada

Small Intracranial Aneurysms

Framing with HyperSoft® 3D or any FDA-approved bare platinum coil. Must fill and finish the the aneurysm with HyperSoft® 3D and/or HyperSoft® helical coils.

PHASE 1- HyperSoft® 3D and HyperSoft® Helical Coils

Framing with HydroFrame® or HydroSoft® 3D coils. Must fill the aneurysm with HydroFrame®, HydroSoft® (3D and/or Helical), and/or HydroFill® Coils and finish with HydroSoft® (3D and/or Helical) Coils.

PHASE 2 - HydroSoft® 3D and HydroSoft® Helical Coils

Medical University of South Carolina

COAST: Coiling of Aneurysms Smaller Than 5mm With Hypersoft® and Hydrogel Coils

To measure imaging outcomes of small (≤ 4.9 mm) intracranial aneurysms utilizing the HyperSoft® 3D (and HydroSoft® 3D, when commercially available) and HyperSoft® helical coils specifically designed for the treatment of small aneurysms.

Measure any neurological morbidity/mortality (evaluated at time of >150-day angiographic follow up)

prolapse/ataque epiléptico

Prevention of Epilepsy by Reducing Neonatal Encephalopathy

Mechanical Environment Pregnancy With Short Cervix

Gabapentin Reduces Opioid Use Postoperatively ("GROUP Study")

COAST: Coiling of Aneurysms Smaller Than 5mm With Hypersoft® and Hydrogel Coils

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