Contact information
Type
Scientific
Primary contact
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 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
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
Trial setting
Hospitals
Trial 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
Phase
Not Applicable
Drug names
Misoprostol
Primary outcome measures
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 trial start date
01/12/2001
Overall trial end date
01/12/2002
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy women, eligible for and requesting medical abortion
2. Agrees to surgical termination should method fail
Participant type
Patient
Age group
Adult
Gender
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, Viet Nam
Trial 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
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
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17560446
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22432980
Publication citations
-
Results
von Hertzen H, Piaggio G, Huong NT, Arustamyan K, Cabezas E, Gomez M, Khomassuridze A, Shah R, Mittal S, Nair R, Erdenetungalag R, Huong TM, Vy ND, Phuong NT, Tuyet HT, Peregoudov A, , Efficacy of two intervals and two routes of administration of misoprostol for termination of early pregnancy: a randomised controlled equivalence trial., Lancet, 2007, 369, 9577, 1938-1946, doi: 10.1016/S0140-6736(07)60914-3.
-
Results
Rodriguez MI, Seuc A, Kapp N, von Hertzen H, Huong NT, Wojdyla D, Mittal S, Arustamyan K, Shah R, , Acceptability of misoprostol-only medical termination of pregnancy compared with vacuum aspiration: an international, multicentre trial., BJOG, 2012, 119, 7, 817-823, doi: 10.1111/j.1471-0528.2012.03310.x.