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
-
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.