Misoprostol administered sublingually for second trimester pregnancy termination
| ISRCTN | ISRCTN72965671 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72965671 |
| Protocol serial number | WHO/HRP ID A15065 |
| Sponsor | UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction |
| Funder | 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) |
- Submission date
- 19/03/2004
- Registration date
- 01/04/2004
- Last edited
- 11/12/2008
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To compare two treatment regimens (0.4 mg misoprostol administered sublingually versus vaginally every three hours up to five doses) for the termination of pregnancy in women with a length of amenorrhoea between 14 to 20 weeks. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Induced abortion |
| Intervention | Misoprostol (0.4 mg) either vaginally or sublingually every three hours up to five doses. Approximate duration of involvement in the study for each subject: first follow up at 15 days post-treatment, another follow-up visit will be carried out according to the practice of the hospital. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Misoprostol |
| Primary outcome measure(s) |
1. The effectiveness to induce complete or partial abortion/induction-to-abortion interval |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 680 |
| Key inclusion criteria | 1. Healthy women 2. Eligible for and requesting legal termination of second trimester pregnancy |
| Key exclusion criteria | No exclusion criteria |
| Date of first enrolment | 01/12/2001 |
| Date of final enrolment | 01/12/2002 |
Locations
Countries of recruitment
- Armenia
- Georgia
- Hungary
- India
- Slovenia
- South Africa
- Switzerland
- Viet Nam
- Zambia
Study participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/09/2004 | Yes | No | |
| Results article | results | 01/01/2009 | Yes | No |
