Buying Precious Time for Baby

Approval for a new drug to curtail premature births

Rosanne, 26, was in the seventh month of her first pregnancy when things began to go wrong. The baby's head was far down in the uterus, apparently ready to begin a premature journey to the outside world. Admitted to the hospital for observation, Rosanne soon went into labor; contractions came only three minutes apart. Had the baby been born then, at a weight of no more than 3 Ibs. and with frail, immature lungs, it would surely have developed life-threatening respiratory problems. But Rosanne and her baby were lucky. Given ritodrine, an experimental medication, Rosanne ceased her labor and gave birth six weeks later to a healthy, 6-lb. 4-oz. daughter.

Last week the chemical that made that happy event possible got formal approval from the Food and Drug Administration for widespread use by expectant women. Calling it "the first safe and effective drug approved to treat premature labor," the federal agency said that ritodrine could help delay a sizable portion of the 300,000 live births a year that occur prematurely (any time before the 36th week of pregnancy) in the U.S.

Though specialized techniques in neonatal intensive care have helped reduce deaths and disability among such infants, their problems remain acute. Besides respiratory distress syndrome, "preemies" are susceptible to heart problems, damage to the gastrointestinal tract, cerebral palsy and mental retardation. Says Rosanne's physician, Dr. Irwin Merkatz, an obstetrical perinatologist at MacDonald House-University Hospitals of Cleveland: "Preterm delivery is the single biggest problem in obstetrics today."

Until now, doctors have tried to prevent or halt early labor by bed rest, sewing up the cervix, prescribing sedatives, hormone inhibitors, various drugs, even alcohol. But these tactics were only partially successful and sometimes produced unpleasant side effects--alcohol, for example, may cause vomiting, diarrhea, tearfulness and headaches.

Ritodrine, developed by a Dutch pharmaceutical house and used in Europe for the past eight years, inhibits labor by relaxing the muscles of the uterus. In tests on 350 pregnant women at eleven centers in the U.S., it has successfully prolonged pregnancy to the 36th week in more than half of the cases. The drug, to be sure, has side effects, including increased maternal and fetal heart rate, a slight drop in blood pressure, palpitations, tremors and nervousness. Recalls one Chicago mother, Susie Kellett: "It was like superspeed." Still, the effects appear to be transient; Kellett went on to give birth to healthy quadruplets.

The drug is not for all women experiencing early labor. Explains Merkatz: "Its use is appropriate in uncomplicated, premature labor where there do not seem to be additional medical complications affecting either the mother or baby." That would rule out women with hypertension or heart conditions, and pregnancies in which the placenta has separated from the uterus or in which the amniotic sac has ruptured and become infected. Nonetheless, ritodrine should be useful to about a quarter of women in preterm labor. Says Merkatz: "It's not a panacea for the whole problem of premature delivery. But it will certainly help."

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