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Progesterone for the prevention of spontaneous preterm birth

A technology of hydroxyprogesterone, use, applied in the field of progesterone for the prevention of premature birth, which can solve the problem of undisplayed health benefits of newborns

Active Publication Date: 2013-04-10
COLUMBIA LAB BERMUDA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current state of conventional technology has not shown any direct health benefits for newborns

Method used

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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. Randomized, double-blind, placebo-controlled trial of the effect of progesterone on preterm birth

[0068] According to the current state of the art, studies were 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 were figure 1 shown. Participants in the study included 611 evaluable pregnant women, of whom 308 were selected into the treatment group and 302 into the placebo group. The selection, classification and subdivision of the two groups in figure 2 outlined in the flowchart. The study was a prospective, randomized, placebo-controlled, double-blind, multicentre trial in pregnant subjects at high risk of spontaneous preterm birth. Study participants were screened from 16 0 / 7 and 22 6 / 7 weeks of gestation. Subjects were randomized to drug or placebo from 18 0 / 7 to 22 6 / 7 weeks of gestation.

[0069] Subjects meeting study criteria betwe...

Embodiment 1b

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

[0072] The data presented in this example provides further analysis of the data presented in Example 1a. The aim of the 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 weeks of gestation, patients were randomized to once-daily treatment with 8% progesterone vaginal gel or placebo until delivery, gestational age of 37 weeks, or occurrence of premature rupture of membranes ( PROM). The primary outcome was preterm birth at ≤32 weeks' gestation. Statistical analysis was based on the principle of intent-to-tr...

Embodiment 2

[0087] Example 2. Randomized trial examining the efficacy of vaginal administration of progesterone in preventing premature preterm birth in women with mid-trimester cervical shortening.

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

[0089] In general, cervical ...

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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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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/57A61K45/06A61P15/06
Inventor G·克里西
Owner COLUMBIA LAB BERMUDA
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