UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032800
Receipt number R000037404
Scientific Title The efficacy of warm sitz bath for early postpartum primiparous women
Date of disclosure of the study information 2018/06/01
Last modified on 2018/05/31 10:09:09

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Basic information

Public title

The efficacy of warm sitz bath for early postpartum primiparous women

Acronym

The efficacy of warm sitz bath for primiparous women

Scientific Title

The efficacy of warm sitz bath for early postpartum primiparous women

Scientific Title:Acronym

The efficacy of warm sitz bath for primiparous women

Region

Japan


Condition

Condition

perineal pain during early postpartum

Classification by specialty

Obstetrics and Gynecology Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of warm sitz baths in early postpartum primiparous women who underwent episiotomy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Perineal pain

Key secondary outcomes

1)Heart rate variability
2)salivary amylase
3)Japanese translation of short version of Profile of Mood States 2


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Participants carry out a warm sitz bath for 10 minutes once after the second day postpartum.

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


 Not applicable

Age-upper limit


 Not applicable

Gender

Female

Key inclusion criteria

Correspond to all the following in recruitment for participants
1)Women are primipara.
2)Women had undergone episiotomy.
3)Women had vaginal delivery after full term.
4)The progress of postpartum is well.
5)women are Japanese and could read and write Japanese.

Key exclusion criteria

Correspond to each the following in recruitment for participants
1)Women had 3rd or 4th perineal laceration.
2)Women had undergone removal of hematoma or resuture of perineum.
3)Women had still birth, neonatal death or their babies were hospitalized in NICU.
4)Women have a mental illness or complications.

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shoko Takeuchi

Organization

Yokohama City University

Division name

School of Medicine, Nursing Course

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan

TEL

045-787-2548

Email

shoko@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shoko Takeuchi

Organization

Yokohama City University

Division name

School of Medicine, Nursing Course

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan

TEL

045-787-2548

Homepage URL


Email

shoko@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

JSPS

Organization

Division

Category of Funding Organization

Japanese Governmental office

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 06 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


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

Preinitiation

Date of protocol fixation

2018 Year 06 Month 04 Day

Date of IRB


Anticipated trial start date

2018 Year 10 Month 01 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

2018 Year 05 Month 31 Day

Last modified on

2018 Year 05 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037404


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name