A Multicenter, Placebo-controlled, Double-blind, Randomized, Parallel-group Study Assessing Efficacy of Progesterone Vaginal Tab for Prevention of Preterm Delivery
- Conditions
- Preterm delivery
- Registration Number
- JPRN-UMIN000013518
- Lead Sponsor
- Japan Society of Premature Birth
- Brief Summary
o significant differences in the frequency of women with a cervical length 20 mm at 34 weeks of gestation were observed between both groups. All preterm births occurred after 34 weeks of gestation, except for one patient in the placebo group. The progesterone group had a lower rate of preterm birth before 37 weeks than the placebo group (3.4% vs. 15.0%, respectively; p < .05).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 119
Not provided
(1) Pregnant women younger than 20 years old when consent is provided (2) Women with multiple pregnancy (3) Pregnant women with preterm premature rupture of membranes (pPROM) (4) Pregnant women with genital haemorrhage (5) Pregnant women with abnormality of fetuses or other fetal appendages (fetal structural anomaly, fetal dysfunction, dysgenesis, placenta praevia, premature separation of normally implanted placenta, single umbilical cord artery, polyhydramnios, oligohydramnios, and so on) (6) Pregnant women who have already underwent cervical cerclage for current pregnancy (7) Pregnant women who started any other treatment for threatened premature labour such as tocolytic agents (8) Pregnant women with severe hepatic function disorder, renal impairment, cardiac disease and others (9) Pregnant women who underwent cervical conization (10) Pregnant women who became pregnant through in vitro fertilization or embryo transfer (11) Pregnant women who used progesterone agents for the current pregnancy (12) Pregnant women who cannot insert vaginal tabs on their own (13) Pregnant women with allergy to progesterone agents (14) Pregnant women from who understanding of this study cannot be obtained (15) Other pregnant women when study doctors conclude that they are not eligible for study enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of pregnant women with the cervical length of 20 mm or more in 34 weeks of gestation
- Secondary Outcome Measures
Name Time Method (1) Administration period of the progesterone vaginal tab (2) The rate of cervical length shortening during the administration period of the progesterone vaginal tab (3) Occurrence of obstetric concomitant diseases (4) Occurrence of adverse events (5) Number of weeks of gestation at the time of delivery (6) Safety toward neonates