Condition category
Pregnancy and Childbirth
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Whilst psychological distress after a miscarriage can be significant and enduring, women are not routinely provided with professional psychological support or any follow-up care. The purpose of this study is to find out how well psychological counselling works in reducing psychological distress after miscarriage.

Who can participate?
Miscarrying women in the Prince of Wales Hospital, Hong Kong are eligible to participate in the study.

What does the study involve?
Patients are randomly allocated to one of two groups: either psychological counselling or routine management without psychological counselling. The counselling group receives a psychological counselling programme conducted in two sessions, one when they are still in the hospital and the second, two weeks after the miscarriage. They are asked to fill in some questionnaires at 6 weeks, 3 months and 6 months after the miscarriage to find out how well the counselling has worked.

What are the possible benefits and risks of participating?
The participants do not have any benefit and risks of taking part in the study.

Where is the study run from?
Prince of Wales Hospital, Hong Kong.

When is the study starting and how long is it expected to run for?
This study started in 2005 and finished in 2006.

Who is funding the study?
This study is funded by the Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong.

Who is the main contact?
Dr Grace Wing Shan Kong

Trial website

Contact information



Primary contact

Prof Grace Wing Shan Kong


Contact details

Department of Obstetrics and Gynaecology
Prince of Wales Hospital
Hong Kong

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A randomised controlled trial of psychological counselling on psychological morbidity after miscarriage


Study hypothesis

Psychological counselling reduces the proportion of patients with psychological morbidity following miscarriage.

Ethics approval

This study is approved by Joint The Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee with CREC Ref. No: CRE-2000.233 in 2003

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

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




For the randomization, patients who agreed to participate in the study gave written consent and were then randomised using a set of sealed, opaque, sequentially numbered envelopes, each containing a computer-generated random number denoting the randomisation result. Randomisation was into one of the following two groups:
Group 1 (Counselling group): Patient in this group received psychological counselling from a nurse counsellor after completion of baseline questionnaires in the hospital before discharge. They were then followed up by the nurse counsellor two weeks later by telephone to reinforce the counselling.
Group 2 (Control group): Patient in this group were managed according to our routine clinical practice and attended by the clinical staff as usual. No specific counselling or follow-up care was arranged.

For the intervention, the counselling programme comprised of two sessions.
The first session usually lasted about 60 minutes and was conducted while the patient was still in hospital. The second session usually lasted about 30 minutes and was conducted two weeks after miscarriage. This session thus aimed at reinforcing the previous information given; to allow the patient to discuss her feelings, worries and physical concerns; to discover possible underlying stress factors. We adopted telephone conselling format mainly for the convenience of the patient.

Intervention type



Drug names

Primary outcome measure

The psychological morbidity [General Health Questionnaire (GHQ-12) and Beck Depression Inventory (BDI) questionnaires] following miscarriage
The psychological outcomes (proportion of patients suffering psychological morbidity and the median psychometric scores) at baseline, six weeks, three months and six months after miscarriage of both counselling group and control group were evaluated.

Secondary outcome measures

The interaction between time and psychological intervention on the psychometric outcome were assessed.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Women aged 18-40 admitted with the diagnosis of miscarriage

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Patient who were unwilling to participate
2. Patient with psychiatric disease requiring active treatment
3. Patient who were non-Chinese
4. Patient who were visitors to Hong Kong (e.g. tourists for whom arranging follow-up would be difficult)

Recruitment start date


Recruitment end date



Countries of recruitment

Hong Kong

Trial participating centre

Prince of Wales Hospital
Hong Kong

Sponsor information


The Chinese University of Hong Kong (Hong Kong)

Sponsor details

Department of Obstetrics and Gynaecology
Prince of Wales Hospital
Hong Kong

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Chinese University of Hong Kong

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Local government


Hong Kong

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

Basic results (scientific)

Publication list

2014 results in:

Publication citations

Additional files

Editorial Notes