Vaginal misoprostol for first trimester termination of pregnancy prior to 9 weeks of gestation
| ISRCTN | ISRCTN18011364 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18011364 |
| Secondary identifying numbers | 831037 |
- Submission date
- 14/10/2002
- Registration date
- 14/10/2002
- Last edited
- 02/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr CSW Ngai
Scientific
Scientific
Department of Obstetrics and Gynaecology
Faculty of Medicine
University of Hong Kong
-
-
Hong Kong
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Misoprostol |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1998 |
| Completion date | 01/01/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/1998 |
| Date of final enrolment | 01/01/2000 |
Locations
Countries of recruitment
- Hong Kong
Study participating centre
Department of Obstetrics and Gynaecology
-
-
Hong Kong
-
Hong Kong
Sponsor information
Hong Kong Health Services Research Fund (Hong Kong)
Government
Government
Health Welfare and Food Bureau
Government Secretariat, HKSAR
20th floor Murray Building
Garden Road
-
-
Hong Kong
| Phone | +852 (0)2973 8288 |
|---|---|
| hsrf@hwfb.gov.hk | |
| Website | http://www.fhb.gov.hk/grants/english/funds/funds_hhsrf/funds_hhsrf_abt/funds_hhsrf_abt.html |
"ROR" |
https://ror.org/03qh32912 |
Funders
Funder type
Government
Hong Kong Health Services Research Fund (Hong Kong)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2000 | Yes | No |
