Vaginal Progesterone in Arrested Preterm Labor
Trial question
What is the role of vaginal micronized progesterone in women with arrested preterm labor?
Study design
Multi-center
Open label
RCT
Population
129 female patients.
Inclusion criteria: women with singleton and twin pregnancies after arrested preterm labor following tocolysis at 24-34 weeks of gestation.
Key exclusion criteria: history of preterm delivery; asymptomatic cervical shortening in the current pregnancy; suspected chorioamnionitis; significant placental abruption; intrauterine fetal death; major fetal malformations; allergy to progesterone; current use of progesterone.
Interventions
N=65 vaginal micronized progesterone (200 mg suppository BID until 36 weeks and 6 days of gestation).
N=64 usual care (no treatment).
Primary outcome
Mean pregnancy prolongation until 37 weeks
40 days
37.4 days
40.0 days
30.0 days
20.0 days
10.0 days
0.0 days
Vaginal micronized
progesterone
Usual
care
No significant
difference ↔
No significant difference in mean pregnancy prolongation until 37 weeks (40 days vs. 37.4 days; AD 2.6 days, 95% CI -3.88 to 9.08).
Secondary outcomes
No significant difference in spontaneous preterm delivery (25% vs. 30%; RR 0.8, 95% CI 0.5 to 1.5).
No significant difference in postpartum hemorrhage (11% vs. 5%; RR 2.3, 95% CI 0.6 to 8.5).
No significant difference in NICU admission (19% vs. 29%; RR 0.7, 95% CI 0.4 to 1.2).
Conclusion
In women with singleton and twin pregnancies after arrested preterm labor following tocolysis at 24-34 weeks of gestation, vaginal micronized progesterone was not superior to usual care with respect to mean pregnancy prolongation until 37 weeks.
Reference
Zohar Nachum, Yael Ganor Paz, Manal Massalha et al. Vaginal Progesterone for Pregnancy Prolongation After Arrested Preterm Labor: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2419894.
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