JRCT ID: jRCTs071180084
Registered date:29/03/2019
Trial of prevention of preterm birth in women with prior preterm birth by vaginal progesterone
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | High risk for preterm birth |
Date of first enrollment | 01/11/2016 |
Target sample size | 100 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Administration of vaginal progesterone capsule (200mg/dl) once daily between 16 and 34 weeks of gestations |
Outcome(s)
Primary Outcome | Rate of preterm birth |
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Secondary Outcome | NICU admission period, neonatal complications, rate of threatened preterm birth, rate of premature rupture of membrane, Fetal death, maternal adverse event |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Female |
Include criteria | women with prior preterm birth after second trimester |
Exclude criteria | 1)prior preterm birth by induction for obstetrics complication 2)contraindication of progesterone 3)multiple pregnancy 4)fetus of severe anomaly or abnormal chromosome |
Related Information
Primary Sponsor | Fujita Yasuyuki |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Yasuyuki Fujita |
Address | 3-1-1, Maidashi, Higashi-ku, Fukuoka Fukuoka Japan 812-8582 |
Telephone | +81-92-642-5395 |
fujita.yasuyuki.889@m.kyushu-u.ac.jp | |
Affiliation | Kyushu university hospital |
Scientific contact | |
Name | Yasuyuki Fujita |
Address | 3-1-1, Maidashi, Higashi-ku, Fukuoka Fukuoka Japan 812-8582 |
Telephone | +81-92-642-5395 |
fujita.yasuyuki.889@m.kyushu-u.ac.jp | |
Affiliation | Kyushu university hospital |