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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025404
Receipt No. R000029242
Scientific Title Cervical pessary for the prevention of preterm delivery.
Date of disclosure of the study information 2017/01/15
Last modified on 2019/06/28

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Basic information
Public title Cervical pessary for the prevention of preterm delivery.
Acronym Preterm LabOr preVEntion, Multicenter study fOr Maternal cervical pessary(LOVE MOM)
Scientific Title Cervical pessary for the prevention of preterm delivery.
Scientific Title:Acronym Preterm LabOr preVEntion, Multicenter study fOr Maternal cervical pessary(LOVE MOM)
Region
Japan

Condition
Condition Preterm Delivery
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to identify the efficacy of cervical pessary in prevention of preterm delivery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Delivery less than 34 weeks gestation.
Key secondary outcomes A)Efficacy
Delivery less than 37weeks, Delivery less than 28weeks, Rupture of membrane less than 34 weeks
B)maternal background
age, pregnancy history, previous medical history, hight, body weight, smoking
C)Safty
Way of delivery, Bleeding at delivery, Cevical laceration, Uterus rupture, pessaty withdrawal, Chorioamnionitis, Vaginitis
D)Treatment for mother
Cervical length, corticosteroid treatment for fetal maturation
E)Background for baby
body weight, Gestational weeks at birth, Apgar score, Evaluation fo umbilical arterial blood gas
F)Safty for baby
Fetal death, Neonatal death, Adverse outcomes(Intraventricular hemorrhage, Respiratory distress syndrome, Retinopathy, Necrotising enterocolitis, Sepsis)
G)Treatment for baby
Respiratory treatment, Photo therapy, Antibiotics, Blood transfurion

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Cervical pessary from 20weeks to 36weeks gestation.
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 1)Pregnant women after 20 weeks gestation, who is disgnosed threatened miscarriage or threatened premature labor.
2)Cervical length of 25mm or less.
3)Women with informed consent for participation in this trial.
Key exclusion criteria 1)Women with multiple pregnant.
2)Majior fetal anomalies.
3)Painful regular uterine contractions.
4)Active vaginal bleeding.
5)Placenta previa.
6)Cervical myoma.
7)History of cone biopsy or cervical cerclage in situ.
8)Other pregnant women when study doctores conclude that they are not eligible for study enrollment.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yasuhiko
Middle name
Last name OZAKI
Organization Nagoya City University Hostpital
Division name Department of Obstetrics and Gynecology
Zip code 467-8602
Address Kawasumi 1, Misuho-cho, Mizuho-ku, Nagoya, AICHI, JAPAN ZIP 467-8601
TEL 052-851-5511
Email yozaki@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name Kyoko
Middle name
Last name KUMAGAI
Organization Nagoya City University Hostpital
Division name Department of Obstetrics and Gynecology
Zip code 467-8602
Address Kawasumi 1, Misuho-cho, Mizuho-ku, Nagoya, AICHI, JAPAN ZIP 467-8601
TEL 052-851-5511
Homepage URL
Email og-nzw@med.nagoya-cu.ac.jp

Sponsor
Institute Department of Obstetrics and Gynecology
Nagoya City University, Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Self funding
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 Clinical research management center, Nagoya city university hospital
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Tel 052-858-7215
Email clinical-research@med.nagoya-cu.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 名古屋市立大学病院(愛知県)
名古屋市立西部医療センター(愛知県)
江南厚生病院(愛知県)
宮城県立こども病院(宮城県)
横浜市北部病院(神奈川県)
国立病院機構佐賀病院(佐賀県)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 15 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 Enrolling by invitation
Date of protocol fixation
2016 Year 12 Month 12 Day
Date of IRB
2019 Year 02 Month 20 Day
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2020 Year 07 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
2016 Year 12 Month 26 Day
Last modified on
2019 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029242

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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