UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027997 |
|---|---|
| Receipt number | 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 | 2020/07/01 17:59:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
| Obstetrics 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
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
tnag-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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
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
99
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
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
| 2020 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032061
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/07/01 | b_研究計画書_2018009SP_.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
