Preterm delivery
Conditions
Interventions
Subjects shall insert a progesterone tab (200mg) /day at bedtime into the vagina by themselves
Subjects shall insert a placebo vaginal tab /day at bedtime into the vagina themselves
Sponsors
Japan Society of Premature Birth
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Pregnant women between 16 weeks and 0 days and 23 weeks and 6 days in gestation when consent is provided and who visit the site as outpatients (2) Pregnant women whose cervical length is 20 mm <= and < 30 mm when consent is provided (3) Pregnant women who provide written consent for participation in this study
Exclusion criteria
Exclusion criteria: (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of pregnant women with the cervical length of 20 mm or more in 34 weeks of gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Countries
Japan
Contacts
Public ContactHiromu Katsuta
ReLife-inc Clinical Research Department
Outcome results
None listed