UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013518 |
|---|---|
| Receipt number | R000015381 |
| Scientific Title | A Multicenter, Placebo-controlled, Double-blind, Randomized, Parallel-group Study Assessing Efficacy of Progesterone Vaginal Tab for Prevention of Preterm Delivery |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2022/04/01 11:00:35 |
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Basic information
Public title
A Multicenter, Placebo-controlled, Double-blind, Randomized,
Parallel-group Study Assessing Efficacy of Progesterone Vaginal Tab for Prevention of Preterm Delivery
Acronym
Trial Of Progesterone vaginal tab In prevention of preterm delivery evaluated by CervicAl Length (TROPICAL Study)
Scientific Title
A Multicenter, Placebo-controlled, Double-blind, Randomized,
Parallel-group Study Assessing Efficacy of Progesterone Vaginal Tab for Prevention of Preterm Delivery
Scientific Title:Acronym
Trial Of Progesterone vaginal tab In prevention of preterm delivery evaluated by CervicAl Length (TROPICAL Study)
Region
| Japan |
Condition
Condition
Preterm delivery
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to study efficacy and safety of a progesterone vaginal tab in prevention of preterm delivery.
Regarding efficacy, preventive effect of shortening of cervical length in the progesterone vaginal tab group will be studied.
Regarding safety, incidence of adverse event will be compared and studied between the progesterone vaginal tab group and the placebo group.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of pregnant women with the cervical length of 20 mm or more in 34 weeks of gestation
Key secondary outcomes
(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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Subjects shall insert a progesterone tab (200mg) /day at bedtime into the vagina by themselves
Interventions/Control_2
Subjects shall insert a placebo vaginal tab /day at bedtime into the vagina themselves
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key 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
Key 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
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Akito |
| Middle name | |
| Last name | NAKAI |
Organization
Nippon Medical School Tama Nagayama Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
206-8512
Address
1-7-1 Nagayama, Tama City, Tokyo. JAPAN 206-8512
TEL
042-371-2111
nakai-3@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hiromu |
| Middle name | |
| Last name | Katsuta |
Organization
ReLife-inc
Division name
Clinical Research Department
Zip code
170-0013
Address
5 F, Koshin Building, 1-47-1 Higashi Ikebukuro, Toshima Ward, Tokyo JAPAN 170-0013
TEL
0359282501
Homepage URL
hkatsuta@relife-inc.com
Sponsor or person
Institute
Japan Society of Premature Birth
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ReLife-inc
Address
5 F, Koshin Building, 1-47-1 Higashi Ikebukuro, Toshima Ward, Tokyo JAPAN 170-0013
Tel
0359282501
hkatsuta@relife-inc.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本医科大学多摩永山病院（東京都）
総合母子保健センター愛育病院（東京都）
東京医科歯科大学（東京都）
自治医科大学附属病院（栃木県）
東京慈恵会医科大学（東京都）
富山大学附属病院（富山県）
杏林大学（東京都）
弘前大学医学部附属病院（青森県）
順天堂大学医学部附属順天堂浦安（東京都）
慶応義塾大学病院（東京都）
順天堂大学医学部附属順天堂医院（東京都）
埼玉医科大学（埼玉県）
昭和大学江東豊洲病院（東京都）
東京大学医学部附属病院（東京都）
独立行政法人国立病院機構岡山医療センター（岡山県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000015381
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34182873/
Number of participants that the trial has enrolled
119
Results
No 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).
Results date posted
| 2022 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
(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
Participant flow
Informed consent will be provided from 16 weeks 0 to 23 weeks 6 to obtain consent to participate.
Study drug administration will be initiated in subjects who are confirmed eligible.
Cervical length will be measured at study entry, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks, 16 weeks and at the end of treatment.
Adverse events
No adverse events attributable to the study drug occurred.
Outcome measures
Percentage of pregnant women who had a cervix length of 20 mm or greater at 34 weeks' gestation
Duration of progesterone vaginal suppository administration
Cervical canal length shortening rate during progesterone vaginal suppositories
Occurrence of obstetric complications
Occurrence of adverse events
Weeks of delivery
Safety for newborns
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 26 | Day |
Last modified on
| 2022 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015381
