Condition category
Pregnancy and Childbirth
Date applied
09/10/2002
Date assigned
09/10/2002
Last edited
02/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr DTS Lee

ORCID ID

Contact details

Department of Psychiatry
The Chinese University of Hong Kong
-
-
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

811019

Study information

Scientific title

Acronym

Study hypothesis

Unexpected outcomes of pregnancy is commonly associated with client dissatisfaction and
psychological morbidity.
Aims and objectives:
To study whether proactive, systematic and interventionist educational counselling in
addition to routine clinical care is effective in reducing psychological morbidity and in improving quality of life and client satisfaction among parturients who suffer from suboptimal outcomes during childbirth.

Ethics approval

This information was not required at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Obstetrics and gynaecology

Intervention

Educational counselling which consists of:
1. Education on the nature, etiology, management and prognosis of suboptimal outcomes
2. Counselling on the adverse emotions associated with suboptimal outcomes using techniques such as listening, clarification, debriefing, facilitation of affect expression and encouragement of positive coping mechanisms
3. Bereavement counselling, when the suboptimal outcomes involve fetal or neonatal death

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

A longitudinal assessment on the psychological well being using the Hospital Anxiety and
Depression Scales, General Health Questionnaire, Clinical Global Impression, and Client
Satisfaction Questionnaire.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/1998

Overall trial end date

01/09/2000

Reason abandoned

Eligibility

Participant inclusion criteria

Parturients who developed suboptimal outcomes during pregnancy. Suboptimal outcomes are defined as:
1. Perinatal deaths (intra-uterine death, stillbirth and neonatal death)
2. Treatment in the neonatal intensive care unit and special care unit
3. Unexpected obstetric events, which include significant antenatal complications, such as hypertension and ante-partum haemorrhage, and intra-uterine and post-partum events, such as emergency caesarean deliveries, operative vaginal deliveries and haemorrhage

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

180

Participant exclusion criteria

Does not meet exclusion criteria

Recruitment start date

01/12/1998

Recruitment end date

01/09/2000

Locations

Countries of recruitment

Hong Kong

Trial participating centre

Department of Psychiatry
-
-
Hong Kong

Sponsor information

Organisation

Hong Kong Health Services Research Fund (Hong Kong)

Sponsor details

Health Welfare and Food Bureau
Government Secretariat
HKSAR
20th floor Murray Building
Garden Road
-
-
Hong Kong

Sponsor type

Government

Website

http://www.fhb.gov.hk/grants/english/funds/funds_hhsrf/funds_hhsrf_abt/funds_hhsrf_abt.html

Funders

Funder type

Research organisation

Funder name

Hong Kong Health Services Research Fund (Hong Kong)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/14511969

Publication citations

  1. Results

    Tam WH, Lee DT, Chiu HF, Ma KC, Lee A, Chung TK, A randomised controlled trial of educational counselling on the management of women who have suffered suboptimal outcomes in pregnancy., BJOG, 2003, 110, 9, 853-859.

Additional files

Editorial Notes