UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015465 |
|---|---|
| Receipt number | R000017979 |
| Scientific Title | Cervical pessary for the prevention of preterm delivery in pregnant women with a short cervix. |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2020/10/21 17:06:03 |
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Basic information
Public title
Cervical pessary for the prevention of preterm delivery in pregnant women with a short cervix.
Acronym
STudy Of Cervical Pessary for the prevention of PreTerm Delivery (STOP PTD Trial).
Scientific Title
Cervical pessary for the prevention of preterm delivery in pregnant women with a short cervix.
Scientific Title:Acronym
STudy Of Cervical Pessary for the prevention of PreTerm Delivery (STOP PTD Trial).
Region
| Japan |
Condition
Condition
preterm delivery
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to identify the efficacy and safety of cervical pessary in prevention of preterm delivery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of term delivery is equal or higher compare to the conventional therapy for prevention of preterm delivery.
Key secondary outcomes
A) Pregnancy outcome
1. Spontaneous delivery before 28 weeks
2. Spontaneous delivery before 37 weeks
3. Gestational age at delivery
4. Tocolytic treatment
5. Premature preterm rupture of membranes
6. Corticosteroid treatment for fetal maturation
7. Chorioamnionitis
8. Hospitalization
9. Vaginal discharge
10. Pessary withdrawal
11. Bleeding at delivery
12. Cervical laceration
13. Uterus rupture
B) Perinatal outcome
1. Fetal death
2. Neonatal death
3. Birth weight
4. Adverse outcomes (Intraventricular hemorrhage, Respiratory distress syndrome, Retinopathy, Necrotising enterocolitis, Sepsis)
5. Hospitalization at NICU
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Cervical pessary from 20 weeks gestation to 36 weeks 6days
Interventions/Control_2
Conventional treatment until 36 weeks 6days
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 with singleton pregnancies
2, Women with a 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) Cervical length id more than 26mm
3) Major fetal anomalies
4) Painful regular uterine contractions
5) Active vaginal bleeding
6) Ruptured membranes
7) Placenta previa
8) Cervical myoma
9) History of cone biopsy or cervical cerclage in situ
10) Other pregnant women when study doctors conclude that they are not eligible for study enrollment.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | KUMAGAI |
Organization
Nagoya City University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
467-0001
Address
kawasumi 1, mizuho-cho, mizuho-ku nagoya, AICHI, JAPAN ZIP 467-8601
TEL
0528515511
kykkumagai@gmail.com
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | KUMAGAI |
Organization
Nagoya City University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
467-0001
Address
kawasumi 1, mizuho-cho, mizuho-ku nagoya, AICHI, JAPAN ZIP 467-8601
TEL
0528515511
Homepage URL
kykkumagai@gmail.com
Sponsor or person
Institute
Nagoya City University Medical School, Department of obstetrics and gynecology
Institute
Department
Personal name
Funding Source
Organization
none
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
0528515511
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | 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
3
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
Terminated
Date of protocol fixation
| 2014 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 17 | Day |
Last modified on
| 2020 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017979
