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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000019834
Receipt No. R000022913
Scientific Title Cooling the Lower Abdomen for Preventing Postpartum Hemorrhage: A Randomized Controlled Trial
Date of disclosure of the study information 2015/12/01
Last modified on 2017/10/29

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Basic information
Public title Cooling the Lower Abdomen for Preventing Postpartum Hemorrhage: A Randomized Controlled Trial
Acronym Cooling for Preventing PPH:RCT
Scientific Title Cooling the Lower Abdomen for Preventing Postpartum Hemorrhage: A Randomized Controlled Trial
Scientific Title:Acronym Cooling for Preventing PPH:RCT
Region
Japan

Condition
Condition women at delivery
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to determine the effectiveness of cooling the lower abdomen in preventing postpartum hemorrhage.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Total blood loss within 2 hours after the birth
Key secondary outcomes Blood loss of 500g or more within 2 hours after the birth
Use of additional uterotonics
Blood loss of 1000g or more within 2 hours after the birth

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Cooling the lower abdomen by putting an ice pack during 2 hours after delivery
Interventions/Control_2 No treatment
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 Healthy pregnant women who are expected to a singleton vaginal birth gestational age of 34 or more weeks
Key exclusion criteria placenta praevia, previous PPH(>1000ml), in utero fetal death, number of previous birth>4, eclampsia, polyhydramnios, a severe haemostasis disease, EFBW>4000g, BMI>40, PIH, impairment of liver function, placental abruption, emergency C/S, use of uterotonics during the third stage of labor, and multiple gestations and those who did not understand Japanese
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Masuzawa
Organization Graduate School of Nursing Science
St. Luke's International University
Division name Doctoral student
Zip code
Address 10-1, Akashi-cho, Chuo-ku, Tokyo, Japan
TEL 03-3543-6391
Email 14DN013@slcn.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Masuzawa
Organization Graduate School of Nursing Science St. Luke's International University
Division name Doctoral student
Zip code
Address 10-1, Akashi-cho, Chuo-ku, Tokyo, Japan
TEL 03-3543-6391
Homepage URL
Email 14DN013@slcn.ac.jp

Sponsor
Institute Graduate School of Nursing Science St. Luke's International University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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
2015 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0186365
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 Main results already published
Date of protocol fixation
2015 Year 11 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 18 Day
Last modified on
2017 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022913

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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