17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor
Summary
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 spontaneous preterm deliveries.
The purpose of this study is to compare between two different modes of treatment with progesterone for the prevention of preterm delivery: weekly injection of 17 alfa hydroxyprogesterone caproate versus daily vaginal administration of progesterone in terms of efficacy, comfort and compliance, safety and cost of treatments.
Study Design
Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
Pregnancy
Intervention
17 alfa hydroxyprogesterone caproate, natural progesterone, 17 alfa hydroxyprogesterone caproate, vaginal progesterone
Location
Meir Medical Center
Kfar Saba
Israel
Status
Active, not recruiting
Source
Meir Medical Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00809939
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Gestonorone Caproate
A long-acting potent progestogen structurally related to PROGESTERONE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1185)
Interferon Alfa-2c
A recombinant alfa interferon consisting of 165 amino acids with arginine at positions 23 and 34. It is used extensively as an antiviral and antineoplastic agent.
Interferon Alfa-2a
A recombinant alfa interferon consisting of 165 amino acids with lysine at position 23 and histidine at position 34. It is used extensively as an antiviral and antineoplastic agent.
Interferon Alfa-2b
A recombinant alfa interferon consisting of 165 amino acid residues with arginine in position 23 and histidine in position 34. It is used extensively as an antiviral and antineoplastic agent.
Epoetin Alfa
This recombinant erythropoietin, a 165-amino acid glycoprotein (about 62% protein and 38% carbohydrate), regulates red blood cell production. Epoetin alfa is produced by Chinese hamster ovary cells into which the human erythropoietin gene has been inserted. (USP Dictionary of USAN and International Drug Names, 1996).
Clinical Trials
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...
We hypothesized that weekly intramuscular injections of 17 hydroxyprogesterone caproate(17P) will reduce the number spontaneous preterm births prior to 35 weeks gestation when compared to...
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...
Prevention of Preterm Delivery in Twin Pregnancies by 17 Alpha-hydroxyprogesterone Caproate
Preterm birth remains a major cause of perinatal morbidity and mortality in developing as well as in developed countries. Despite major clinical research efforts aimed at reducing the inci...
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...
PubMed Articles
Intramuscular 17 α-hydroxyprogesterone caproate (Makena(®)), a synthetic progestin, is indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of a singl...
Abstract Objective: To examine the influence of maternal pre-pregnancy body mass index (BMI) on the rates of recurrent spontaneous preterm birth (SPTB) in women receiving 17α-hydroxyprogesterone capr...
Despite the introduction of 17-alpha-hydroxyprogesterone caproate (17P), the national preterm birth (PTB) rate remains unchanged. Our objectives were to determine whether the overall rate of PTB has d...
Objective: To assess cerclage benefit in women with short cervix also receiving 17-α-hydroxyprogesterone caproate (17P) to prevent recurrent preterm birth (PTB). Methods: Secondary analysis of a mult...
OBJECTIVE: We sought to examine if 17-alpha-hydroxyprogesterone caproate (17OHPC) effectiveness is dependent on the earliest gestational age (GA) at prior spontaneous preterm birth (SPTB) when adminis...
