Condition category
Pregnancy and Childbirth
Date applied
01/04/2020
Date assigned
15/04/2020
Last edited
14/04/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Epidural analgesia is the administration of opioids and/or local anesthetics into the epidural space. It is often administered during childbirth.
The clinical explanation of epidural analgesia by anesthesiologist would often begin after the pregnant mother (parturient) is admitted into the hospital. However, because of labor pain, the decision of receiving epidural analgesia would often be made by the companion of the parturient, such as the husband, instead of the parturient herself. The researchers believe that this situation should be remedied and thus conducted a study comparing the satisfaction and level of epidural analgesia comprehension in parturients receiving the routine procedure and those receiving a prenatal shared decision-making (SDM) intervention.

Who can participate?
Women who have recently given birth by natural spontaneous delivery who used epidural analgesia during the natural birth process

What does the study involve?
During their 28th week of gestation, the SDM group is given a health education leaflet with a QR code linking to health education videos that explain what epidural analgesia is and its advantages and disadvantages. After giving birth patients answer a questionnaire.

What are the possible benefits and risks of participating?
After the intervention, participation in decision-making may improve. There is no risk in participating in this trial.

Where is the study run from?
Chi Mei Medical Center (Taiwan)

When is the study starting and how long is it expected to run for?
June 2018 to December 2019

Who is funding the study?
This study was supported by Chi Mei Medical Center (Taiwan), under the grant CMFHR108110.

Who is the main contact?
Dr Ying-Jen Chang, 0201day@yahoo.com.tw

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ying-Jen Chang

ORCID ID

http://orcid.org/0000-0002-4824-6216

Contact details

Department of Anesthesiology
Chi Mei Medical Center
901 Zhonghua Road
Yongkang District
Tainan
710
Taiwan
+886 62812811
cmh7760@mail.chimei.org.tw

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRB Serial No.: 10705-010

Study information

Scientific title

Evaluating the satisfaction in parturients receiving epidural analgesia after prenatal shared decision-making intervention

Acronym

Study hypothesis

The satisfaction and level of epidural analgesia comprehension will improve in parturients receiving the routine procedure and those receiving a prenatal shared decision-making (SDM) intervention.

Ethics approval

Approved DATE, Institutional Review Board of the Chi Mei Medical Center (901 Zhonghua Road, Yongkang District, Tainan, 701, Taiwan R.O.C.; +886-6-281-2811-53720; cmhirb@mail.chimei.org.tw), ref: 10705-010

Study design

Interventional non-randomised before and after study

Primary study design

Interventional

Secondary study design

Before and after study design

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Epidural analgesia during childbirth

Intervention

During their 28th week of gestation, the shared decision making (SDM) group was given a health education leaflet with a QR code linking to health education videos that explained what epidural analgesia is and its advantages and disadvantages. A specific questionnaire in local language (Chinese)—designed to measure the satisfaction of labor pain relief, the degree of access to information, and the communication from health care staff—incorporated items from three health care communication questionnaires: Pregnancy and Maternity Care Patients’ Experiences Questionnaire (PreMaPEQ), Preterm Birth Experience and Satisfaction Scale (P-BESS), and Women’s Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Satisfaction measured using a novel questionnaire combining elements of Pregnancy and Maternity Care Patients’ Experiences Questionnaire (PreMaPEQ), Preterm Birth Experience and Satisfaction Scale (P-BESS), and Women’s Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) after giving birth.

Secondary outcome measures

Comprehension of the consenting process measured using a novel questionnaire combining elements of Pregnancy and Maternity Care Patients’ Experiences Questionnaire (PreMaPEQ), Preterm Birth Experience and Satisfaction Scale (P-BESS), and Women’s Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) after giving birth.

Overall trial start date

05/06/2018

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Parturients after natural spontaneous delivery who have used epidural analgesia during the natural birth process

Participant type

Other

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

1. Mental disorders or emotional disorders, regardless of whether they are receiving psychiatric medication
2. Drug addiction or drug dependence (for example, those who have a history of drug use, or who have used morphine analgesics daily for more than 30 mg of oral morphine equivalent for more than six weeks)
3. Cannot read Chinese
4. In the intensive care unit after delivery

Recruitment start date

14/06/2018

Recruitment end date

31/12/2019

Locations

Countries of recruitment

Taiwan

Trial participating centre

Chi Mei Medical Center
901 Zhonghua Road Yongkang District
Tainan
710
Taiwan

Sponsor information

Organisation

Chi Mei Medical Center

Sponsor details

901 Zhonghua Road
Yongkang District
Tainan
710
Taiwan
+886 62812811ext. 52652
cmh8888@mail.chimei.org.tw

Sponsor type

Hospital/treatment centre

Website

http://www.chimei.org.tw/main/cmh_department/54220/english/

Funders

Funder type

Hospital/treatment centre

Funder name

Chi Mei Medical Center

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Taiwan

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/08/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/04/2020: Trial’s existence confirmed by Institutional Review Board of the Chi Mei Medical Center