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Recruitment status
Unique ID issued by UMIN UMIN000025756
Receipt No. R000029634
Scientific Title The effects of video lecture on expulsive efforts of women receiving epidural analgesia for labor and delivery
Date of disclosure of the study information 2017/01/20
Last modified on 2017/01/20

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Basic information
Public title The effects of video lecture on expulsive efforts of women receiving epidural analgesia for labor and delivery
Acronym The effects of video lecture on expulsive efforts of women receiving epidural analgesia for labor and delivery
Scientific Title The effects of video lecture on expulsive efforts of women receiving epidural analgesia for labor and delivery
Scientific Title:Acronym The effects of video lecture on expulsive efforts of women receiving epidural analgesia for labor and delivery
Region
Japan

Condition
Condition Pregnant women requesting labor pain epidural
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Expulsive efforts add to the force of uterine contractions to hasten descent and shorten the second stage of labor. It is said to be difficult for women receiving effective analgesia to feel uterine contraction, urge to push and push effectively. However, there have been no reports on the expulsive efforts of women receiving epidural analgesia. Therefore, we conduct this study. First, we compare the effectiveness of expulsive efforts between labor epidural group and no-analgesia group. Secondly, we assess the effects of the educational video which we make for the purpose of demonstrating expulsive effort such as posture, breathing, and following the midwives' lead on the parturients' pushing and attitude to pushing.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Expulsive efforts assessed by midwives on the day of delivery
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 [first step study][second step study]
We hand the questionnaire to midwives.Within 24 hours after delivery, midwives assess the parturients' pushing and attitude to pushing subjectively.
[second step study]
1. We measure the diameter of internal juglar vein with ultrasound at just before pushing and during pushing.
2. We measure the circumference of the abdomen at the height of umbilicus at just before pushing and during pushing.
3. We measure R-R interval of electrocardiograph at just before pushing and during pushing.
4. We measure the lowest heart rate at just before pushing and during pushing.
Interventions/Control_2 [second step study]
We assess the effects of the educational video which we make for the purpose of demonstrating expulsive effort such as posture, breathing, and following the midwives' lead on the parturients' pushing and attitude to pushing and parturient progress.
We divide parturients planninng epidural analgesia for labor and delivery and receiving the childbirth class in our hospital into the following two groups.Parturients of group A watch the educational video in addition to ordinary explanation about epidural analgesia. Parturients of group B watch non-educational video in addition to ordinary explanation about epidural analgesia. Moreover, we emphasize the importance of effective expulsive efforts to the parturients of group A.
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
55 years-old >=
Gender Female
Key inclusion criteria [first step study]
1. parturients planninng the vaginal delivery in our hospital
2. age>20
3. parturients written informed consent

[second step study]
1. parturients planninng epidural analgesia for labor and delivery and receiving the childbirth class in our hospital
2. age>20
3. parturients written informed consent
Key exclusion criteria [first step study]
1. parturients with mental diseases
2. parturients with diseases which may be exacerbated by strong expulsive efforts
3. parturients with neuromuscular diseases
4. parturients with difficulty in language communication
[in addition to above , in case of parturients planninng epidural analgesia for labor and delivery ]
5. parturients with contraindications of epidural analgesia
6. parturients whom the anesthesia range don't extend from tenth thracic spnal cord to third sacral cord

[second step study]
1. parturients with mental diseases
2. parturients with diseases which may be exacerbated by strong expulsive efforts
3. parturients with neuromuscular diseases
4. parturients with difficulty in language communication
5. parturients with contraindications of epidural analgesia
6. parturients whom the anesthesia range don't extend from tenth thracic spnal cord to third sacral cord
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitomi Asaba
Organization Hamamatsu university hospital
Division name department of anesthesiology and intensive care
Zip code
Address 1-20-1 Handayama, Higashi Ward, Hamamatsu City, Shizuoka, Japan
TEL 053-435-2738
Email hitomi.a@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitomi Asaba
Organization Hamamatsu university hospital
Division name department of anesthesiology and intensive care
Zip code
Address 1-20-1 Handayama, Higashi Ward, Hamamatsu City, Shizuoka, Japan
TEL 053-435-2738
Homepage URL
Email hitomi.a@hama-med.ac.jp

Sponsor
Institute Hamamatsu university hospital
Institute
Department

Funding Source
Organization none
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
2017 Year 01 Month 20 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
Date of protocol fixation
2016 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 15 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
2017 Year 01 Month 20 Day
Last modified on
2017 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029634

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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