UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019834 |
|---|---|
| Receipt number | 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 22:15:30 |
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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
| Obstetrics 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
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
14DN013@slcn.ac.jp
Sponsor or person
Institute
Graduate School of Nursing Science St. Luke's International University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022913
