UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Trial of prevention of preterm birth in women with prior preterm birth by vaginal progesterone
Title of the study (Brief title)	Trial of prevention of preterm birth in women with prior preterm birth by vaginal progesterone
Region	Japan

Condition
Condition	pregnant women at high risk of preterm birth
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine whether the administration of vaginal progesterone in women with prior preterm birth after second trimester prevents preterm birth
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	rate of preterm birth
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Administration of vaginal progesterone capsule (200mg/dl) once daily between 16 and 34 weeks of gestations
Interventions/Control_2
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	women with prior preterm birth after second trimester
Key exclusion 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
Target sample size	100

Research contact person
Name of lead principal investigator	Yuka Sato
Organization	Kyushu university hospital
Division name	Comprehensive Maternity and Perinatal Care Center
Address	3-1-1, Maidashi, Higashi-ku,Fukuoka
TEL	092-641-1151
Email	s-yuka@med.kyushu-u.ac.jp

Public contact
Name of contact person	Yuka Sato
Organization	Kyushu university hospital
Division name	Comprehensive Maternity and Perinatal Care Center
Address	3-1-1, Maidashi, Higashi-ku,Fukuoka
TEL	092-641-1151
Homepage URL
Email	s-yuka@med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu university hospital
Institute
Department

Funding Source
Organization	Kyushu university hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 08 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 08 Day
Last modified on	2017 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026565