UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	kykkumagai@gmail.com

Sponsor
Institute	Nagoya City University Medical School, Department of obstetrics and gynecology
Institute
Department

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
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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017979