Q&A

Natural progesterone prevents preterm birth in high-risk pregnancies

Author and Disclosure Information

  • BACKGROUND: Synthetic progesterone has been used to reduce the number of preterm births; this is the first study to evaluate the effects of natural progesterone. This form of progesterone may offer less teratogenic risk and fewer metabolic effects.
  • POPULATION STUDIED: This study was performed in a tertiary medical center in Brazil. Included subjects had asymptomatic, high-risk, singleton pregnancies, and at least 1 previous spontaneous preterm birth, Data were insufficient to show whether heliox can avert tracheal intubation or affect mortality prophylactic cervical cerclage, or uterine malformation. Subjects were randomized to receive progesterone or placebo. The median age of the women was about 27 years.
  • STUDY DESIGN AND VALIDITY: The researchers conducting this randomized, double-blind study enrolled 157 patients at high risk of preterm labor. Allocation to treatment may not have been concealed from the enrolling investigator. Progesterone 100 mg or placebo was administered daily by vaginal suppository from weeks 24 to 34 of gestation.
  • OUTCOMES MEASURED: The primary endpoint was preterm birth, defined as birth occurring before 37 weeks’ gestation. Other outcomes were frequency of episodes of uterine contractions, episodes of preterm labor, and response to treatment with beta-mimetics.
  • RESULTS: The overall preterm birth rate was 21.1%. The incidence of preterm birth was lower in the progesterone compared with the placebo group (13.8% vs 28.5%; number needed to treat [NNT]=7). More women delivered before 34 weeks in the placebo group than in the progesterone group (18.6% vs 2.8%; NNT=7). Mean contraction frequency was less in the progesterone group compared with the placebo group (23.8% vs 54.3%; P=.0001).


 

PRACTICE RECOMMENDATIONS

The administration of natural progesterone decreases both the number of episodes of uterine contractions and the incidence of preterm birth in women at high risk for preterm delivery.

Previous trials used synthetic (not natural) progesterone; another placebo-controlled clinical study would be of value to evaluate safety and effects of natural progesterone. These results do not apply to women at low risk for preterm birth because this study evaluated only high-risk patients.

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