UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025756
Receipt number 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 10:14:17

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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 or person

Institute

Hamamatsu university hospital

Institute

Department

Personal name



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

Value
https://center6.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