A recent study published in The New England Journal of Medicine (NEJM), in February 2016, concluded that the use of a steroid medicine Betamethasone can lower the chances of neonatal respiratory complications in pregnant women who are at a high risk of a late preterm delivery.

Preterm delivery, as defined by Centers of Disease Control and Prevention (CDC) is the ‘birth of the infant before 37 weeks of pregnancy’.

One in 10 infants born in United States of America in the year 2014 had a preterm birth, according to a CDC report. This can put the child at high risk for serious disability, long-term neurological deficits, and death. The chances of complications rise as the period of pregnancy decreases. Preterm birth is the leading cause for infant death today in US, especially for children born before 32 weeks of pregnancy.

Betamethasone benefit

This study (an RCT) was a randomized, placebo-controlled, double-blind trial, conducted in seventeen tertiary medical centers in US during a period of five years. Women at a high risk of delivery within 12 hours to seven days were eligible. 2,831 pregnant women carrying a single child with high chances of late preterm delivery (34-37 weeks) were enrolled in the study.

The women were given the drug Betamethsone intramuscularly or a matching placebo. A good result in the trial was considered to be the decreased occurrence of treatment for the infant in the first 72 hours of birth, decreased stillbirth, or death within 72 hours of birth.

The study found that women who were injected with Betamethsone had a decrease in neonatal respiratory complications (11.6 percent) compared to the women who were not given the drug (14.4 percent).

Other complications like severe respiratory complications, transient tachypnea (delayed clearance of fetal lung fluid) of the newborn, surfactant use, and bronchopulmanory dysplasia (disruption of normal lung development due to prolonged mechanical ventilation) also had a lower occurrence rate in the newborns of the pregnant women who were given the drug. The newborns also had a relatively smaller period of intensive care nursery stay than late term children born without the administration of the drug to their mothers.

A high rate of neonatal hypoglycemia (low glucose level in the infants) was more common in the infants whose mother received the drug (24 percent) than the infants whose mother received a placebo (15 percent).

The lead author, Cynthia Gyamfi- Bannerman, MD, the Director of Maternal-Fetal Fellowship Program and a Co-Director at Columbia University Preterm Prevention Center, explained that the majority of preterm deliveries occur in the late preterm period.

The current rate is of 300,000 late preterm labors each year in the United States. Premature births have continuously increased in incidence despite efforts made to lower their numbers. Rates rose from 9.4 percent to 12.3 percent between 1981 and 2003. Recently, the increase in number of premature births is near 12 percent. Many reasons have been theorized to account for this change, such as increased obesity rates, infertility treatments, demographic changes, increase in maternal age at the time of pregnancy, and the maternal co morbid conditions (multiple disorders at the same time). Late term newborns are the fastest growing group of neonates and account for 74 percent of all preterm births, and nearly 8 percent of total births.

Dr. Cynthia believes that now a practical solution is at hand to work out this problem.

She said in a statement, “The majority of preterm deliveries occur in the late preterm period. We now have a treatment that can significantly improve outcomes for these at risk babies.”

Another statement published by the Society for Maternal-Fetal Medicine (SMFM), after the original study’s publication, had six recommendations:

  • One dose of 12 mg (24 hours apart), for pregnant women( 34-36 week and six days) carrying a single child, who are expected to give birth in the next seven days
  • In women with preterm labor symptoms, waiting for evidence of preterm labor, before starting the treatment is advised
  • Not to use tocolysis in an attempt to delay delivery to complete the Betamethasone course because ‘it is unclear whether the benefits of betametasone administration are outweighed by the risks of attempts to delay delivery’
  • Not to use Betamethsone in women with potential indication of delivery unless there is a definite plan for late preterm delivery
  • Closely monitor and utilize standard guidelines for diagnosis and treatment of neonatal hypoglycemia
  • Not implement the ‘antenatal late preterm steroids protocol’ for conditions not used in the RCT study unless as a part of a research study

These suggestions are important because Betamethasone is already being recommended for women with high chances of early preterm labor (before 34 weeks), expected to deliver within seven days. But data is unavailable for late preterm deliveries. These suggestions provide a working ground for future research and clinical applications for late preterm births.

Betamethasone is a glucocorticoid that can be administered intramuscularly or applied as a derma-cream.

The drug can be used for adrenocrtical insufficiency, adrenogenital syndrome, hypocalcemia, thyroiditis, rheumatic disorders, collagen diseases, dermatological diseases, allergic conditions, ocular disorders, asthma, sarcoidosis, advanced pulmonary and extra-pulmonary tuberculosis, Loffler’s syndrome, berylliosis, aspiration pneumonitis, antenatal use in early preterm labor, hematologic disorders, GI diseases, low back pain, organ transplants, trichinosis, carpel tunnel syndrome, and neoplastic diseases.

The drug, in the form of a cream, is also on the WHO’s List of Essential Medicines.