Vaginal misoprostol for first trimester termination of pregnancy prior to 9 weeks of gestation

ISRCTN	ISRCTN18011364
DOI	https://doi.org/10.1186/ISRCTN18011364
Protocol serial number	831037
Sponsor	Hong Kong Health Services Research Fund (Hong Kong)
Funder	Hong Kong Health Services Research Fund (Hong Kong)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr CSW Ngai
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Misoprostol
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2000

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

Department of Obstetrics and Gynaecology

-
-
Hong Kong

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2000		Yes	No