Sildenafil, the active ingredient in Viagra, is currently being studied for possible use in the prevention of fetal oxygen deprivation.
To the growing list of off-label applications for sildenafil citrate, the active ingredient in Viagra, it’s possible that we might soon be able to add the prevention of stillbirth. A team of researchers at Australia’s University of Queensland has laid the foundation for a study to determine if sildenafil given to women in labor can reduce the risk of fetal stress.
In a recent issue of the “Journal of Translational Medicine,” the Australian research teams lays out in detail its plans for the study, which seeks to find out if sildenafil given to women in labor increases the flow of oxygen-rich blood to the fetus. If so, it could help prevent intrauterine hypoxia, or oxygen starvation, that can cause stillbirth, as well as nonfatal consequences, such as brain damage, epilepsy, and other problems.
In the United States, intrauterine hypoxia and birth asphyxia together rank 10th among the top 10 causes of infant death, according to data from the National Center for Health Statistics, the principal health statistics agency of the U.S. federal government.
Plans for Study Outlined
The Australian researchers plan to recruit a number of mothers-to-be between the ages of 18 and 50 who each have a single fetus and are about to come to term. Women who are found to have cardiovascular, kidney, liver, ocular, or hypertensive disease will be excluded from the study, as will those whose medical histories indicate that taking sildenafil could be otherwise problematic. The trial will be a double-blind study in which roughly half of the participants will be randomly selected to receive either sildenafil citrate or a placebo in the hours prior to the delivery of their babies.
Those who get the sildenafil will be given a 50-milligram tablet at the onset of labor and an additional 50-milligram tablet every eight hours following the initial dose up to a maximum dose of 150 milligrams, or three tablets. The others will get placebo at identical intervals. Ultrasound scans will be performed at the outset of the study and at appropriate intervals thereafter to see what, if any, changes can be detected in the fetus.
Labor Can Be Perilous Time
In the article outlining the protocol for their study, researchers note that “labor is perhaps the most hazardous time in pregnancy. As many as 20 percent of cerebral palsy cases in term infants result from intrapartum events and up to 63 percent of babies who develop intrapartum compromise have no prior risk factors.” Researchers express the hope that giving sildenafil to women in labor will increase blood flow to the placenta and thus reduce the risk of fetal hypoxia in the intrapartum period, which begins with the onset of labor and continues until delivery.
Currently, obstetricians detecting signs of fetal distress resort to caesarean delivery in an effort to prevent further damage to the fetus. Researchers suggest that the number of caesarean deliveries performed in cases of fetal distress could decrease significantly if treatment with sildenafil has the desired effects.
Toll of Birth Asphyxia
The magnitude of the problem is staggering, according to research data cited by Action Medical Research for Children, a nonprofit foundation based in the United Kingdom. It estimates that nearly 25 percent of the babies who die within the first month of life worldwide fall victim to birth asphyxia. This problem is defined as “oxygen deprivation and a reduced blood supply to the brain around the time of birth that lasts long enough to be harmful,” which is precisely the problem that the Australian researchers hope sildenafil will alleviate.
According to Action Medical Research, the first sign that a baby is experiencing problems during childbirth comes from abnormalities detected in the fetal heartbeat. Charles Redman, a professor at the University of Oxford and lead author of a 2012 study on birth asphyxia, said, “Sometimes it is difficult to interpret changes in a baby’s heartbeat, which leads to uncertainty over whether a baby actually has birth asphyxia. In this situation, doctors often make a fail-safe decision to intervene, and deliver the baby by caesarean section, thinking it is better to be safe than sorry. Often though, it turns out that the baby was actually fine and the caesarean — a major operation for the mother — was unnecessary.”
Could Computers Help?
In an effort to better pinpoint which fetal heartbeat abnormalities actually signal signs of fetal oxygen deprivation, Redman and his colleagues are conducting a study to determine if computer analysis improves the accuracy of such calls. If so, this also could cut down on the number of caesarean deliveries that are medically unnecessary.
Much research remains to be done before it can be determined whether the administration of sildenafil to women in labor cuts down on childbirth problems associated with oxygen deprivation. In the meantime, however, it seems the little blue pill has found a number of medical applications beyond its primary use as a treatment of erectile dysfunction. These off-label uses include:
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- Treats pediatric patients with congenital cardiac and pulmonary problems. In one such case, reported by CBS News in New York, Victoria Dooley was born with a rare condition that caused one-half of her heart to fail not long after birth. Low doses of sildenafil allow her weakened heart to function more efficiently, keeping her alive until such time as she is strong enough to undergo a heart transplant. Victoria celebrated her fourth birthday in November 2015 and has already undergone at least three surgeries to strengthen her cardiac function.
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- Eases the symptoms of pediatric patients with Duchenne muscular dystrophy, or DMD. An inherited disorder that targets one in every 3,600 boys, DMD is characterized by abnormally low blood flow to the muscles. In a study published in a 2014 issue of “Neurology,” researchers found that doses of sildenafil or tadalafil, the active ingredient in Cialis, significantly improved blood flow to the muscles of 10 young patients with DMD.
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- Alleviates the symptoms of benign prostatic hyperplasia, a noncancerous enlargement of the prostate gland. Men suffering from BPH may experience a number of unpleasant symptoms, including urinary urgency and frequency, urinary incontinence, post-urinary dribbling, and interrupted urinary stream. According to Harvard Men’s Health Watch, “research suggests that the most popular and effective drugs for ED [of which sildenafil is one] may substantially reduce the symptoms of BPH.”
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- Eases the symptoms of Raynaud’s phenomenon, a condition in which cold temperatures or emotional distress temporarily decreases blood flow to the fingers. Some individuals suffering from Raynaud’s have found that the use of sildenafil counteracts the effects of the disorder even when other modes of treatment fail to bring relief.
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- Relieves the symptoms of pulmonary arterial hypertension, or PAH, a condition in which high blood pressure in the arteries that go from the heart to the lungs makes it more difficult to breathe. Although not really off-label, a lower-strength formulation of sildenafil, brand-named Revatio and also available as a generic, has been shown to ease the symptoms of PAH. By increasing blood flow to the lungs, it makes it easier for PAH patients to breathe.
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