Pretreatment with vaginal misoprostol before vacuum aspiration
| ISRCTN | ISRCTN85366519 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85366519 |
| Protocol serial number | WHO/HRP ID A15066 |
| 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
- 22/03/2004
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | To evaluate if vaginal administration of 0.4 mg misoprostol facilitates cervical dilation, reduces complications of first trimester induced abortion, and is acceptable to women. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Induced abortion |
| Intervention | Misoprostol (0.4 mg) versus placebo tablet three hours before vacuum aspiration. Approximate duration of involvement in the study for each subject is one follow up visit ten days post-treatment. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Misoprostol |
| Primary outcome measure(s) |
Will evaluate if preoperative treatment with 0.4 mg misoprostol administered vaginally three hours before vacuum aspiration can reduce complications of surgical first trimester abortion. |
| 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 | 4464 |
| Key inclusion criteria | 1. Pregnancy of less than 12 completed weeks 2. Be informed about the study and sign a consent form 3. Agree to return for a follow-up visit five to ten days after surgery |
| 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
- China
- Cuba
- Hungary
- India
- Mongolia
- Romania
- Slovenia
- Switzerland
- Viet Nam
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 | 12/05/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
