A preliminary new study of the drug Pitocin, frequently given to women to help start or speed up childbirth, has raised concerns about its safety.
The study found that the use of Pitocin to induce or augment labor was linked to unexpected admissions to the neonatal intensive care unit (NICU) and to lower Apgar scores -- a test to check newborns' physical condition in the minutes following birth.
"These results suggest that Pitocin use is associated with adverse effects on neonatal outcomes," said researcher Dr. Michael Tsimis, a resident in obstetrics and gynecology at the Albert Einstein College of Medicine at Beth Israel Medical Center in New York, in a statement.
Pitocin is a synthetic version of oxytocin, a hormone released naturally during labor that causes uterine contractions. It is typically given intravenously to induce labor or to speed it up when health care providers deem it necessary.
In the new study, presented at the annual clinical meeting of the American Congress of Obstetricians and Gynecologists on Tuesday, researchers looked at the records of more than 3,000 women who had delivered full-term babies at Beth Israel between 2009 and 2011.
Pitocin use appeared to be a risk factor for babies being admitted to the NICU and staying for at least one day. It was also tied to Apgar scores of less than 7. A score under 7 is a red flag, indicating that the baby needs medical attention, but is not an indication that the newborn necessarily has a serious medical condition or that he or she will have lasting health issues.
The Beth Israel study did not determine what actually caused the babies' troubles.
"If you're in labor and your labor stops, it's tricky to figure out [if there was a later] adverse outcome because your labor stopped or because of the Pitocin use," Dr. Siobhan Dolan, medical adviser to the nonprofit March of Dimes, told The Huffington Post. She called the new findings "interesting" and said they raised questions warranting further investigation.
"These findings could be explained if oxytocin was being used more commonly to deliver babies at earlier gestational ages or if the unborn baby was experiencing distress in utero," echoed Dr. Christopher Colby, chair of the division of neonatal medicine at the Mayo Clinic Children's Center. "I do not think any strong conclusions can be made about oxytocin in pregnancy based on this study."
Other recent research has begun to take a more critical look at the use of Pitocin, at the same time that broad efforts to curb the induction of labor before 39 weeks have picked up steam.
A 2011 Cochrane Review concluded that Pitocin did not seem to harm mothers or babies and appeared to shorten labor times by nearly two hours. But use of the drug did not lower cesarean section rates, which is one of the reasons why some doctors administer it, the authors wrote.
Many individual institutions have also taken a hard look at their policies around Pitocin use. During the two-year period examined by researchers in the new study, Beth Israel implemented system-level interventions to manage when the drug is administered and how it is accounted for in patients' medical records. Those changes led to a significant drop in rates of Pitocin use.
Nevertheless, Pitocin remains the most widely used drug for inducing labor, a common procedure in the U.S. The Centers for Disease Control and Prevention estimate found that more 23 percent of pregnant women underwent induction in 2010.
And experts say it is far too soon to draw any conclusions about the safety of Pitocin for newborns based on the new study.
"There are times when it plays an essential role and times when it may not be needed," Dolan said. "I think we need more data before we can conclude it's not as safe as we once thought."
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