UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on pathophysiology and prediction of placental abruption and subchorionic hemorrhage
Title of the study (Brief title)	Research on pathophysiology and prediction of placental abruption and subchorionic hemorrhage
Region	Japan

Condition
Condition	Preterm delivery Placental abruption
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of plasminogen activator inhibitor type 1 in mid-term pregnancy for the prediction of preterm delivery or placental abruption
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The frequency of preterm delivery
Key secondary outcomes	The frequency of placental abruption

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Pregnant women between 24th and 27th week of gestation whose blood will be collected for mid-term examination
Key exclusion criteria	Pregnant induced hypertension Multiple pregnancy Gestational diabetes mellitus Diabetes mellitus Severe bacterial infection Fetal anomaly The case whose blood was collected in the afternoon
Target sample size	200

Research contact person
Name of lead principal investigator	Hiroaki Itoh
Organization	Hamamatsu University Hospital
Division name	Perinatal Center
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL	053-435-2309
Email	hitou-endo@umin.ac.jp

Public contact
Name of contact person	Tomoaki Oda
Organization	Hamamatsu University School of Medicine
Division name	Obstetrics & Gynecology
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL	053-435-2309
Homepage URL
Email	D15017@hama-med.ac.jp

Sponsor
Institute	Department of Obstetrics & Gynecology, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	No funding source
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	浜松医科大学附属病院(静岡県)/Hamamatsu University Hospital 富士市立中央病院(静岡県)/Fuji City General Hospital

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 15 Day
Anticipated trial start date	2016 Year 08 Month 15 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	Observation of the date of delivery among pregnant women whose blood was collected in mid-term of pregnancy

Management information
Registered date	2016 Year 08 Month 08 Day
Last modified on	2018 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026971