Comparison of two routes and two intervals of administration of misoprostol for the termination of early pregnancy: a randomised multicentre trial
| ISRCTN | ISRCTN10531821 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10531821 |
| Secondary identifying numbers | WHO/HRP ID A05217 |
- Submission date
- 19/03/2004
- Registration date
- 01/04/2004
- Last edited
- 10/10/2014
- 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 Helena von Hertzen
Scientific
Scientific
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| vonhertzenh@who.int |
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 | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 01/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 2100 |
| Key inclusion criteria | 1. Healthy women, eligible for and requesting medical abortion 2. Agrees to surgical termination should method fail |
| Key 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 |
| Date of first enrolment | 01/12/2001 |
| Date of final enrolment | 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
CH-1211
Switzerland
Sponsor information
UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Research organisation
Research organisation
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Website | http://www.who.int/reproductive-health/hrp/ |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
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)
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 | 09/06/2007 | Yes | No | |
| Results article | results | 01/06/2012 | Yes | No |
