FDA ap­proved an app to pre­vent preg­nancy. Can an app do that?

The Borneo Post - Nature and health - - Vital Signs - By Rachel Siegel

CONTRACEPTION? Yes, there’s an app for that. And an FDA-ap­proved app at that. Nat­u­ral Cy­cles has just be­come the first app ap­proved by the govern­ment to pre­vent preg­nancy. The Swedish-based com­pany had been cleared in Europe in 2017 and is an emerg­ing name within the “Femtech” in­dus­try - a catch-all for “fe­male health tech­nol­ogy” that has reaped an es­ti­mated $1 bil­lion of in­vest­ment world­wide in the past three years. This app is mar­keted as “a nat­u­ral method of contraception that is pow­ered by a smart al­go­rithm.” It sells the idea of “em­pow­er­ing women.”

Not all are con­vinced that the app rep­re­sents the fu­ture of contraception, or should even be used now. Women might be drawn to hav­ing a sense of con­trol over their re­pro­duc­tive lives. And as with so much else in mod­ern daily life, their data is at their fin­ger­tips. But gy­nae­col­o­gists and women who have used the app cau­tion that it re­quires a level of dili­gence: The app is only as good as the in­for­ma­tion women en­ter. And they point to in­ci­dents of un­ex­pected preg­nan­cies by those who have re­lied on it.

Nat­u­ral Cy­cles works by cal­cu­lat­ing which days of the month a woman is likely to be fer­tile based on in­for­ma­tion she en­ters about her men­strual cy­cle and basal body tem­per­a­ture. The method, of­ten re­ferred to as fer­til­ity aware­ness-based method, iden­ti­fies the days per men­strual cy­cle in which a woman is fer­tile.

Women us­ing the app must take their tem­per­a­tures im­me­di­ately af­ter wak­ing up each morn­ing us­ing a basal body ther­mome­ter. Basal body ther­mome­ters are more sen­si­tive than oth­ers. The ther­mome­ter comes with the app, which costs $79.99 (RM327) an­nu­ally.

Clin­i­cal stud­ies to screen Nat­u­ral Cy­cles’ ef­fec­tive­ness for use as a contraception in­cluded more than 15,500 women who used the app for an av­er­age of eight months. Of those who used the app per­fectly as di­rected, 1.8 per cent be­came preg­nant (what is known as the “fail­ure rate”), ac­cord­ing to the FDA. The app had a “typ­i­cal use” fail­ure rate of 6.5 per cent, and ac­counted for women who some­times didn’t use the app as di­rected and had un­pro­tected sex on fer­tile days.

Juan Acuna, an OB-GYN spe­cial­ist at Florida In­ter­na­tional Univer­sity and an ad­viser to Nat­u­ral Cy­cles, said there has been a long-stand­ing view that nat­u­ral contraception - like the rhythm method, for ex­am­ple - was not fail safe to pre­vent preg­nancy in women who are fer­tile and hav­ing sex with­out other forms of contraception. Nat­u­ral contraception re­quires women be ed­u­cated about their cy­cles and will­ing to map out when they are fer­tile.

A soft­ware like Nat­u­ral Cy­cles runs those cal­cu­la­tions, he said. Still like most other forms of birth con­trol, Acuna said women shouldn’t solely rely on the app dur­ing their first few cy­cles of us­ing it. “It helps fill a vacuum in the world of nat­u­ral contraception,” Acuna said. Laura MacIsaac, as­so­ciate pro­fes­sor of ob­stet­rics, gy­nae­col­ogy and re­pro­duc­tive science at the Ic­ahn School of Medicine at Mount Si­nai, said Nat­u­ral Cy­cles was “a lit­tle more ex­cit­ing” in that it tracks both men­strual cal­en­dars and basal body tem­per­a­ture.

But she cau­tioned against forms of contraception that re­quire such in­tense main­te­nance and attention, es­pe­cially for women seek­ing long-term preg­nancy pro­tec­tion. “High-main­te­nance meth­ods are the ones that have the high­est fail­ure rates, not be­cause they don’t work bi­o­log­i­cally but be­cause they don’t work in nor­mal peo­ples’ lives,” MacIsaac said. That can in­clude women who travel or have oth­er­wise un­pre­dictable sched­ules, or women who can­not rit­u­al­is­ti­cally take their tem­per­a­tures be­fore do­ing any­thing else in the morn­ing. – Wash­ing­ton Post.

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