Progesterone for the prevention of spontaneous preterm birth

A technology for hydroxyprogesterone, pregnant women, in the field of progesterone for the prevention of preterm birth, which can solve the problem of unproven newborn health benefits

Active Publication Date: 2010-01-27
COLUMBIA LAB BERMUDA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The current state of conventional technology has

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  • Progesterone for the prevention of spontaneous preterm birth
  • Progesterone for the prevention of spontaneous preterm birth
  • Progesterone for the prevention of spontaneous preterm birth

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1a

[0067] Example 1a. A randomized, double-blind, placebo-controlled trial of the effect of progesterone on preterm birth

[0068] Based on the current state of the art, a study was conducted to examine the effect of progesterone on preterm labor and preterm birth in women with a previous history of preterm birth. The baseline data of the study are figure 1 shown. Participants in the study included 611 evaluable pregnant women, of whom 308 were selected for the treatment group and 302 were selected for the placebo group. The selection, classification and subdivision of the two groups are figure 2 outlined in the flowchart. The study is a prospective, randomized, placebo-controlled, double-blind, multicenter trial in pregnant subjects at high risk of spontaneous preterm birth. Study participants were screened from 160 / 7 and 226 / 7 gestational weeks. Subjects were randomized from 180 / 7 to 226 / 7 gestational weeks to receive drug or placebo.

[0069] Subjects meeting the study ...

Embodiment 1b

[0071] Example 1b. Follow-up of a randomized, double-blind, placebo-controlled trial on the effect of progesterone on preterm birth

[0072] The data presented in this example provides a further analysis of the data presented in Example 1a. The purpose of this trial was to determine whether prophylactic administration of vaginal progesterone reduces the risk of preterm birth in women with a history of spontaneous preterm birth.

[0073] The trial was a randomized, double-blind, placebo-controlled multinational trial that enrolled and randomized 659 pregnant women with only a history of spontaneous preterm birth.

[0074] Between 180 / 7 and 226 / 7 gestational weeks, patients were randomized to once-daily treatment with 8% progesterone vaginal gel or placebo until delivery, 37 weeks of gestational age, or the occurrence of premature rupture of membranes ( PROM). The primary outcome was preterm birth at ≤32 gestational weeks. Statistical analysis was based on the intent-to-treat...

Embodiment 2

[0087] Example 2. A randomized trial investigating the efficacy of vaginal progesterone for preventing premature preterm birth in women with a shortened cervix in the second trimester.

[0088] The study further included women with no history of preterm birth but with a short cervix at enrollment. Although the population with only a short cervix included 9 patients, the results suggest a possible effect of progesterone: 40% (2 / 5) delivery rates at ≤32 weeks with placebo and ≤32 weeks with progesterone The delivery rate at 32 weeks was 0 (0 / 4). Because some participants with a prior history of preterm birth also had a short cervix, the preterm study population was divided into quartiles based on cervical length. The lowest quartile (≤3.2cm) and patients with only short cervix were pooled and subdivided sequentially, primary outcomes and secondary outcomes for women with cervical length ≤3.0cm and image 3 shown.

[0089] Generally, cervical length <2.8 cm was determined in 46...

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Abstract

A method for treating or preventing spontaneous preterm birth in pregnant women and improving neonatal morbidity and mortality. The method includes administering to a pregnant woman in need thereof an effective amount of a progesterone sufficient to prolong gestation by minimizing the shortening or effacing of her cervix. Treatment and prophylaxis with progesterone in pregnant women having symptoms of short cervix has been clinically shown to increase neonatal health.

Description

[0001] Cross References to Prior Applications [0002] This application claims priority to US Provisional Application 60 / 888,480, filed February 6, 2007, and US Provisional Application 60 / 973,667, filed September 19, 2007, both of which are incorporated herein by reference in their entirety. technical field [0003] The present invention relates to a method for treating or preventing spontaneous premature birth in pregnant women while improving the health of the newborn. More particularly, the invention relates to a method for treating or preventing the onset of preterm labor leading to preterm labor by administering to a pregnant woman an amount of progesterone sufficient to prolong pregnancy by delaying the shortening or disappearance of the cervix. . In addition, the present invention relates to a method for treating or preventing the onset of premature delivery and simultaneously reducing neonatal birth rate by administering a certain amount of progesterone to pregnant wo...

Claims

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Application Information

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IPC IPC(8): A61K31/57A61K45/06A61P15/06
Inventor G·克里西
Owner COLUMBIA LAB BERMUDA
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