PREEMPT trial: Progesterone offers ‘no benefit’ to women with first-trimester bleeding
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SAN DIEGO — Progesterone was not effective at preventing miscarriage or prematurity in patients who presented with first-trimester vaginal bleeding, according to results of the PREEMPT trial.
Findings from the multicenter, double-blind, randomized study call into question previous evidence that suggested the hormone could improve clinical outcomes.
“First-trimester bleeding is a common problem in early pregnancy that is associated with an increased risk of prematurity,” Haim A. Abenhaim, MD, MPH, FRCSC, an OB/GYN and maternal-fetal medicine specialist at McGill University’s Jewish General Hospital, told Healio. “In light of the evidence that progesterone is effective in reducing prematurity in specific clinical contexts such as prior preterm birth, we sought to evaluate its role in preventing prematurity in pregnancies complicated by first-trimester bleeding.”
Abenhaim said a survey of obstetrical care providers showed it was common for them to prescribe progesterone to pregnant women — “the rationale being that it is a safe medication, and it may be helpful.”
The PREEMPT trial — conducted between 2016 and 2020 — compared 200 mg micronized progesterone, vaginally administered nightly from presentation to 34 weeks’ gestation, and a placebo that appeared identical to the study drug. The trial included women with vaginal bleeding and live intrauterine pregnancy at less than 14 weeks’ gestation, and it excluded women with multifetal gestations, recurrent pregnancy losses, cervical insufficiency or bleeding unrelated to placentation.
The primary outcome was the occurrence of live term pregnancy, and secondary outcomes included adverse events for mothers and newborns and time to miscarriage or birth. According to the researchers, 264 patients were included in the progesterone group and 269 patients received a placebo. Baseline characteristics were similar between the two study arms, they said.
Results showed that the percentage of patients with a live term birth was 74.6% in the progesterone group and 70.6% in the placebo group. The two groups had comparable risks for abortion at less than 20 weeks (14.4% vs. 16%), preterm birth (10.2% vs. 12.3%) and stillbirth (0.9% vs. 1.3%).
Moreover, the researchers saw no differences in the rates of maternal or newborn adverse outcomes between the two groups, nor did they see any differences in the time-to-event for miscarriage or birth.
Abenhaim suggested the results from PREEMPT were conclusive.
“There is no benefit to prescribing progesterone to patients who present with first trimester bleeding,” he said.
The oral abstract presented by Abenhaim at the ACOG Annual Clinical & Scientific Meeting earned second place at the conference, according to the organizers.