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Confirmatory Study of 17P Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery

2014-07-23 21:11:56 | BioPortfolio

Summary

As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical trial of 17P for the prevention of preterm birth prior to 35 weeks, 0 days of gestation in women with a singleton pregnancy, aged 18 years or older, with a previous singleton spontaneous preterm delivery. The study also includes a population pharmacokinetic (PK) substudy to assess the hydroxyprogesterone caproate (HPC) exposure-response relationship and the effect of body mass index (BMI) on the PK of 17P.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Preterm Birth

Intervention

Hydroxyprogesterone Caproate Injection, 250mg/mL, Vehicle

Location

Central Alabama OB-GYN Associates, P.A.
Montgomery
Alabama
United States
36106

Status

Recruiting

Source

Hologic, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:56-0400

Clinical Trials [1559 Associated Clinical Trials listed on BioPortfolio]

Treatment of Preterm Labor With 17 Alpha-Hydroxyprogesterone Caproate

The goal of our research will be to determine the effectiveness of 17 alpha-hydroxyprogesterone caproate (17P) in the treatment of preterm delivery. Treatment with progesterone is emergin...

17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor

Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous studies showed that administration of progesterone to pregnant women at high risk, decrease spontan...

Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in High Risk Pregnancies

A recently completed trial of weekly injections of 17 alpha hydroxyprogesterone caproate (17P) found significant effectiveness for 17P in preventing recurrent preterm birth. However, the g...

17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth (PTB) in Twin and Triplet Pregnancies

Hypothesis: Among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal mo...

Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.

Preterm birth is the leading cause of neonatal death and a significant cause of life long disability and health problems. It has been shown that the drug 17-hydroxyprogesterone caproate ca...

PubMed Articles [4907 Associated PubMed Articles listed on BioPortfolio]

Impact of Obesity on the Rate of Recurrent Spontaneous Preterm Birth in Women Treated with 17-alpha Hydroxyprogesterone Caproate.

 We sought to determine if the rate of recurrent spontaneous preterm birth (PTB) in women treated with 17-α hydroxyprogesterone caproate (17-OHPC) is modified by maternal body mass index (BMI).

A Double-Blind, Randomized, Placebo-Controlled Trial of 17 Alpha-hydroxyprogesterone Caproate in the Management of Preterm Premature Rupture of Membranes.

 The objective of this study was to evaluate whether weekly administration of 17 α-hydroxyprogesterone caproate (17-OHPC) increases the number of women who achieve 34 weeks of gestation after prete...

Progesterone for Prevention of Preterm Birth: Shortcomings and Unintended Consequences of the Orphan Drug Act.

Preterm birth is a problem of major public health significance that continues to plague our country despite the existence of a therapy, 17α-hydroxyprogesterone caproate, with known efficacy in reduci...

Epigenetic Regulation of the Nitric Oxide Pathway, 17-α Hydroxyprogesterone Caproate, and Recurrent Preterm Birth.

Utilization, Cost, and Outcome of Branded vs Compounded 17-Alpha Hydroxyprogesterone Caproate in Prevention of Preterm Birth.

Medical and Biotech [MESH] Definitions

A synthetic progestin that is derived from 17-hydroxyprogesterone. It is a long-acting contraceptive that is effective both orally or by intramuscular injection and has also been used to treat breast and endometrial neoplasms.

A parameter usually used in PRENATAL ULTRASONOGRAPHY to measure the length of the uterine neck (CERVIX UTERI). Cervical length or its shortening is used to identify and prevent early cervical opening and PRETERM BIRTH.

Drugs that prevent preterm labor and immature birth by suppressing uterine contractions (TOCOLYSIS). Agents used to delay premature uterine activity include magnesium sulfate, beta-mimetics, oxytocin antagonists, calcium channel inhibitors, and adrenergic beta-receptor agonists. The use of intravenous alcohol as a tocolytic is now obsolete.

A long-acting potent progestogen structurally related to PROGESTERONE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1185)

Postnatal deaths from BIRTH to 365 days after birth in a given population. Postneonatal mortality represents deaths between 28 days and 365 days after birth (as defined by National Center for Health Statistics). Neonatal mortality represents deaths from birth to 27 days after birth.

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