Contact information
Type
Scientific
Contact name
Dr Helena von Hertzen
ORCID ID
Contact details
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
vonhertzenh@who.int
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
WHO/HRP ID A05217
Study information
Scientific title
Acronym
Study hypothesis
To investigate the feasibility of the misoprostol-only regimen (0.8 mg vaginally or sublingually every 3 hours versus every 12 hours up to three doses).
Ethics approval(s)
Institutional review boards at all participating hospitals and the World Health Organization (WHO) Secretariat Committee on Research on Human Subjects gave ethics approval.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Induced abortion
Intervention
Four treatment groups:
A: Sublingual misoprostol every 3 hours
B: Sublingual misoprostol every 12 hours
C: Vaginal misoprostol every 3 hours
D: Vaginal misoprostol every 12 hours
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Misoprostol
Primary outcome measure
Effectiveness, induction to abortion interval, side effects and acceptability.
Approximate duration of involvement in the study for each subject: first follow-up at 15 days post-treatment, second follow-up (if required) at 42 days, subsequent follow-up as needed.
Secondary outcome measures
No secondary outcome measures
Overall study start date
01/12/2001
Overall study end date
01/12/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy women, eligible for and requesting medical abortion
2. Agrees to surgical termination should method fail
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
2100
Participant exclusion criteria
1. Any indication of serious past or present illness
2. Allergic to misoprostol or with a strong allergic tendency in general
3. Heavy smokers (greater than 20 cigarettes a day)
4. With a scar in the uterus or cervix or any gynaecological anomaly detected with ultrasound
5. A history or evidence of mitral stenosis, glaucoma, or sickle cell anaemia
6. Diastolic blood pressure greater than 90 mmHg
7. Uncontrolled bronchial asthma
8. Systolic blood pressure less than 90 mmHg
9. History or evidence of thromboembolism or liver disease
10. Presence of an intrauterine device in utero
11. Haemolytic disorders
Recruitment start date
01/12/2001
Recruitment end date
01/12/2002
Locations
Countries of recruitment
Armenia, Cuba, Georgia, India, Mongolia, Switzerland, Viet Nam
Study participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Sponsor details
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
Sponsor type
Research organisation
Website
http://www.who.int/reproductive-health/hrp/
ROR
Funders
Funder type
Research organisation
Funder name
United Nations Development Programme (UNDP)/United Nations Population Fund (UNFPA)/World Health Organization (WHO)/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/06/2007 | Yes | No | |
| Results article | results | 01/06/2012 | Yes | No |