UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031586
Receipt number R000036028
Scientific Title Trial of prevention of preterm birth in pregnancy after preterm birth by progesterone
Date of disclosure of the study information 2018/03/05
Last modified on 2019/04/16 19:46:17

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Basic information

Public title

Trial of prevention of preterm birth in pregnancy after preterm birth by progesterone

Acronym

Trial of prevention of preterm birth in pregnancy after preterm birth by progesterone

Scientific Title

Trial of prevention of preterm birth in pregnancy after preterm birth by progesterone

Scientific Title:Acronym

Trial of prevention of preterm birth in pregnancy after preterm birth by progesterone

Region

Japan


Condition

Condition

pregnancy after preterm birth

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine whether progesterone prevent preterm birth in pregnancy after preterm birth

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

rate of preterm birth

Key secondary outcomes



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

Prevention

Type of intervention

Medicine

Interventions/Control_1

Injection of progesterone 250mg into muscle once weekly between 16 and 36 weeks of gestations

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

pregnancy women after preterm birth

Key exclusion criteria

1) prior preterm birth by induction for obstetrics complication
2) contraindication of progesterone
3) multiple pregnancy
4) fetus of severe anomaly or abnormal chromosome

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mika Mizoguchi

Organization

Wakayama Medical University

Division name

Department of Obstetrics and Gynecology

Zip code


Address

811-1, Kimiidera, Wakayama City

TEL

073-441-0631

Email

ma-mika@wakayama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mika Mizoguchi

Organization

Wakayama Medical University

Division name

Department of Obstetrics and Gynecology

Zip code


Address

811-1, Kimiidera, Wakayama City

TEL

073-441-0631

Homepage URL


Email

ma-mika@wakayama-med.ac.jp


Sponsor or person

Institute

Wakayama Medical University

Institute

Department

Personal name



Funding Source

Organization

Wakayama Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 03 Month 05 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

Completed

Date of protocol fixation

2018 Year 02 Month 13 Day

Date of IRB

2018 Year 02 Month 13 Day

Anticipated trial start date

2018 Year 02 Month 15 Day

Last follow-up date

2019 Year 03 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

2018 Year 03 Month 05 Day

Last modified on

2019 Year 04 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036028


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name