Condition category
Pregnancy and Childbirth
Date applied
14/10/2002
Date assigned
14/10/2002
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 CSW Ngai

ORCID ID

Contact details

Department of Obstetrics and Gynaecology
Faculty of Medicine
University of Hong Kong
-
-
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

831037

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Medical abortion

Intervention

Patients will be randomised into two groups:
1. Group one will be treated using misoprostol with three drops of water (the 'water group')
2. Group two will only use misoprostol (the 'no water group')

Intervention type

Drug

Phase

Not Specified

Drug names

Misoprostol

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1998

Overall trial end date

01/01/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. The duration of menstrual delay is less than 49 days
2. The size of the uterus on pelvic examination is compatible with the estimated duration of pregnancy
3. A positive pregnancy test
4. There is no history of significant medical illness
5. Age greater than 16 years old
6. Requests legal termination of pregnancy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

80

Participant exclusion criteria

1. History or evidence of disorders that represent a contraindication to the use of misoprostol (mitral stenosis, glaucoma, sickle cell anaemia, diastolic pressure >100 mm Hg, bronchial asthma)
2. History or evidence of thrombo-embolism, severe or recurrent liver disease or pruritus of pregnancy
3. Presence of intrauterine contraceptive device (IUCD) in utero
4. Suspect or proven ectopic pregnancy
5. Heavy smoker (smoking >10 cigarettes daily in the past 2 years) or had another risk factor for cardiovascular disease

Recruitment start date

01/01/1998

Recruitment end date

01/01/2000

Locations

Countries of recruitment

Hong Kong

Trial participating centre

Department of Obstetrics and Gynaecology
-
-
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
+852 (0)2973 8288
hsrf@hwfb.gov.hk

Sponsor type

Government

Website

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

Funders

Funder type

Government

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

2000 results in http://www.ncbi.nlm.nih.gov/pubmed/10783370

Publication citations

  1. Results

    Ngai SW, Tang OS, Chan YM, Ho PC, Vaginal misoprostol alone for medical abortion up to 9 weeks of gestation: efficacy and acceptability., Hum. Reprod., 2000, 15, 5, 1159-1162.

Additional files

Editorial Notes