Vaginal Progesterone supplementation decreases preterm births, neonatal morbidity and mortality in women with twin gestation and short cervix: an updated meta-analysis of individual patient data

Administration of vaginal progesterone to asymptomatic women with a twin gestation and a sonographic short cervix (cervical length ≤ 25 mm) in the mid-trimester reduces the risk of preterm birth occurring at < 30 to < 35 gestational weeks, neonatal mortality and some measures of neonatal morbidity, without any demonstrable deleterious effects on childhood neurodevelopment.

The article was published online in Ultrasound in Obstetrics and Gynecology, the official journal of the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG).

The meta-analysis included the results of 6 studies, encompassing 303 women pregnant with twins, all of whom had a cervical length of 25 mm or less in the midtrimester. Of these, 159 women received vaginal progesterone and 144 received a placebo or no treatment. Women who received vaginal progesterone were 31 percent less likely to deliver before 33 weeks of pregnancy (31 percent for those receiving vaginal progesterone, compared to 43 percent for those who did not). Vaginal progesterone also reduced the rate of preterm delivery before 32 weeks and 34 weeks. All results were statistically significant.

The risk of preterm birth < 33 weeks was reduced by 31% and neonatal death by 47% and also reduced the rate of respiratory distress syndrome (RDS), birth weight < 1500 g and use of mechanical ventilation.

No significant difference in the risk of neurodevelopmental disability at 4–5 years of age between children exposed prenatally to vaginal progesterone and those exposed to placebo.

“The findings represent persuasive evidence that treatment with vaginal progesterone in women with a short cervix and a twin gestation reduces the frequency of preterm birth, neonatal complications such as respiratory distress syndrome, and importantly, neonatal death,” said the study’s first author, Roberto Romero, M.D., Chief of the Perinatology Research Branch at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD/NIH). Dr. Romero emphasized that individual patient data meta-analyses represent the “gold standard” in the hierarchy of scientific evidence to answer clinical questions.

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