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Vaginal gel reduces preterm births in some women


5 Star



Vaginal gel reduces preterm births in some women

Our Review Summary

Both stories hit many of our marks, but this one provided much needed independent commentary, provided a better explanation of the evidence and gave readers cost information and information about possible clinical applications that were either missing or confusing in the Times story.


Why This Matters

Preterm births can lead to serious complications for both the chlidren and the mothers and are a leading cause of neonatal death. So far, treatments to prevent preterm birth have had limited success. This study indicates that there is a superior intervention for women who meet certain criteria, and this story does a better job explaining what this new study means in a way that women both inside that category and outside will be able to easily understand.


Does the story adequately discuss the costs of the intervention?


The story addresses costs in a much more straight forward way than the LA Times blog piece. It says, “Although the company didn’t address price, vaginal progesterone already is sold to treat different conditions, for roughly $20 for a day’s dose.”

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

The story quantifies the benefits in a variety of ways. The best sentence in the story was “Treating 14 women with a short cervix prevented one preterm birth, comparable to or better than some other well-accepted obstetric treatments, the researchers said.” But, the LA Times story excelled in providing numbers in absolute terms instead of merely in percentages.

Does the story adequately explain/quantify the harms of the intervention?


The story stated, “The women experienced no significant side effects” – so we’ll give it a satisfactory score.  The study itself found that, “There were no differences in the incidence of treatment-related adverse events between the groups.” This is important context because pregnancy interventions can have consequences for both the mother and the child.

Does the story seem to grasp the quality of the evidence?


The story adequately evaluated the quality of the evidence and provided good cautionary notes. For example, the first quote in the story says tells readers that this is not a silver bullet study. “There will never be ‘the’ solution to preterm birth,” cautions lead researcher Dr. Roberto Romero of the National Institutes of Health. “There will be multiple solutions, and we believe this is one important solution.” The LA Times story lacked this context and also had a headline that was too definitive, saying “Premature births may be reduced with hormone gel”. Both stories were scant on details about the study design, saying only that the study was conducted at “44 medical centers around the world.” This story, at least, provided the additional detail that the study initially sought out women suffering from a shortened cervix by screening a huge number of women. “The study screened 32,000 otherwise healthy pregnant women and found 2.3 percent did, which Fleischman said would equate to about 100,000 U.S. women in a year.”

Does the story commit disease-mongering?


The story did an adequate job explaining pre-term labor in clear terms and in showing that this study only provides hope for a subgroup of women it says. “Many factors can lead to premature birth, but Wednesday’s study targets one subset: the thousands of women who develop an unusually shortened cervix, the gateway to the uterus.” We wish, though, that the story had been as specific as the Times story in explaining the conditions necessary for this treatment to work. The Times story said, “The reduction applies only to women with a short cervix (between 1 centimeter and 2 centimeters), not for women at high risk for other reasons. But for these women, few medications have been found effective at keeping a baby in the womb longer.” We do wish that both stories had included some of the information provided by the National Institutes of Health, which said in its news release about the study, “Infants born preterm are at high risk of early death and long term health and developmental problems. In 2005, there were 12.9 million preterm births worldwide ( In the United States, 12.8 percent of infants were born preterm in 2008 ( Preterm infants are at increased risk for death in the first year of life, and breathing difficulties, cerebral palsy, learning disabilities, blindness and deafness (”


Does the story use independent sources and identify conflicts of interest?

The story quotes one independent expert, to good effect, while the LA Times story quoted zero. “This is very good news, and very timely,” said Dr. John Larsen of George Washington University, a spokesman for the American College of Obstetricians and Gynecologists who wasn’t involved with the research. “People have been using vaginal progesterone for a while, and it’s not been in the high-priced stratosphere.” The Times story also undercut the significance of the research by saying, “And, of course, the trial was funded by the maker of the progesterone gel, to be marketed as Prochieve.” The AP story more accurately states, “The study was a collaboration between NIH and Prochieve maker Columbia Laboratories Inc. of Livingston, N.J., which plans to seek Food and Drug Administration approval for the drug for women with short cervix.”

Does the story compare the new approach with existing alternatives?

Not Satisfactory
The story did a good job explaining what the study examined but did not compare the progesterone treatments very effectively to existing methods of stalling birth in this particular subset of women.

Does the story establish the availability of the treatment/test/product/procedure?


The story does a much better job than the LA Times blog piece of making it clear which drug could end up being a good therapy for certain women. The Times story, through confusing language, may lead readers to believe that an expensive, injectable drug called Makena, which has made headlines recently because of its high price, was one of the drugs studied and a possible solution for women. This story, however, said clearly, “This treatment is not related to an injection called Makena, a synthetic hormone that is controversial because of its high price tag. That drug is aimed at women who’ve already had one preemie and now are pregnant again.” This story also provided additional context about the possible clinical applications of this study’s findings. It says, “The findings may prompt more doctors to begin routinely measuring cervical length, using an easy and fairly inexpensive ultrasound scan, midway through pregnancy.”

Does the story establish the true novelty of the approach?


Should this treatment method become standard for certain women, it would be a novel intervention, and this story makes that clear.

Does the story appear to rely solely or largely on a news release?


This story went well beyond the news releases from the journal and from the NIH, while the LA Times story provided only a little additional information beyond the releases.

Total Score: 9 of 10 Satisfactory


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