Preterm Birth Clinical Trial
Official title:
A Randomized, Open-Label, Controlled, Multi-Center Study on the Efficacy of a Sustained Release Progesterone Cerclage Cervical Pessary at Doses of 6.3 g or 7.7 g for the Prevention of Preterm Birth and a Maximum Duration of 20 Weeks.
Assess the efficacy of 2 Cervical Pessaries containing 6.3 g and 7.7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous birth before gestation weeks 32 (31 weeks and 6 days) and 34 (33 weeks and 6 days), when the pessary is inserted during weeks 16th and 24th and removed at 36 weeks and 6 days in pregnant women at high risk of premature birth.
Participant selection will be performed by screening the general population of pregnant women
with single fetus monitored by the Hospital Healthcare Network, to investigate by serial
transvaginal ultrasound performed between gestation weeks 16 (0 day to 7 days) and 24 (0 day
to 7 days) those patients who have a cervical length between 10 mm and 25 mm, and/or women
with a single fetus and cervical length ≥10 mm presenting one or more of the following risk
factors:
1. preterm birth prior to 35 (34 weeks and 6 days) weeks of gestation;
2. premature rupture of membranes prior to 35 (34 and 6 days) weeks of gestation.
After insertion of the pessary or beginning of the administration with vaginal progesterone
capsules and until 28 weeks of gestation, participants in the 3 treatment groups will be
monitored every 4 weeks at the most or more often, if the site has established so as a
control standard. After 28 weeks, patients should be monitored every 2 weeks.
The proportions of spontaneous preterm delivery before gestation weeks 32 and 34 will be
compared between the control group and the 2 groups with the pessaries containing different
doses of progesterone.
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