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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027997
Receipt No. R000032061
Scientific Title Efficacy of eicosapentaenoic acid on the prevention of preterm birth in women with cervical shortening
Date of disclosure of the study information 2017/08/01
Last modified on 2019/07/03

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Basic information
Public title Efficacy of eicosapentaenoic acid on the prevention of preterm birth in women with cervical shortening
Acronym Efficacy of eicosapentaenoic acid on the prevention of preterm birth in women with cervical shortening
Scientific Title Efficacy of eicosapentaenoic acid on the prevention of preterm birth in women with cervical shortening
Scientific Title:Acronym Efficacy of eicosapentaenoic acid on the prevention of preterm birth in women with cervical shortening
Region
Japan

Condition
Condition threatened preterm delivery
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether eicosapentaenoic acid supplementation reduce the incidence of preterm birth in women with cervical shortening.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Preterm birth
Key secondary outcomes 1)gestational age at delivery
2)Birth weight, Apgar score, pH of umbilical arterial blood
3)Cervical length
4)Maternal adverse event
5)Neonatal adverse event
6)Occurrence of adverse events toward neonates
7)Duration of hospital stays
8)Duration of use of a tocolytic agent (ritodrine hydrochloride preparation, magnesium sulfate preparation)
9)Nutrient intakes

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Participants take eicosapentaenoic acid 1800mg per day from the day of confirming cervical shortening to 35w6d of gestation or the day of delivery when the deliery occurs before 35w6d.
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 1)Between 24 to 28weeks of gestation, pregnant women with shortened cervix length (< or = 25 mm)
or Between 29 to 33weeks of gestation, pregnant women with shortened cervix length (< or = 30 mm)
2)Pregnant woman who is at 20 years old or more.(at the time of informed consent)
3)Patients who were required to provide written informed consent
Key exclusion criteria 1)Patients who was transferred from other hospitals
2)Patients with a past history of conization
3)Patients who underwent cervical cerclage in current pregnancy
4)Premature rupture of the membrane
5)fetal anomalies detected by ultrasonography
6)Prolapsed fetal membranes
7)Chorioamnionitis
8)White blood cell count > or =15,000/mm3
or CRP > or =1.0mg/dl
9)Placenta previa
10)Multiple pregnancy
11)Painful degeneration of myomas during pregnancy
12)Uterine malformations
13)Previous medication of eicosapentaenoic acid
14)Medication with low-dose aspirin
15)Patients judged to be ineligible by attending physician
Target sample size 128

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Nagamatsu
Organization The University of Tokyo Hospital
Division name Obstetrics and Gynecology
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL 03-3815-5411
Email tnag-tky@umin.ac.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Nagamatsu
Organization The University of Tokyo Hospital
Division name Obstetrics and Gynecology
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL 03-3815-5411
Homepage URL
Email tnag-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization MSD life science foundation, public interest incorporated foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Office for Human Research Studies (OHRS), university of Tokyo
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
Tel 03-5841-0818
Email ethics@m.u-tokyo.ac.jp

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
2017 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 29 Day
Last modified on
2019 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032061

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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