A double-blind, randomised, controlled multicentre trial of misoprostol treatment prior to Vacuum Aspiration for termination of early pregnancy
| ISRCTN | ISRCTN98284169 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98284169 |
| Protocol serial number | 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
- 17/04/2007
- Registration date
- 03/05/2007
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Helena von Hertzen
Scientific
Scientific
Department of Reproductive Health and Research
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo-controlled multicentre clinical trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Cervical priming prior to VA |
| Study objectives | Null hypothesis: There is no difference between first trimester abortion with and without pre-abortion priming of the cervix with 400 micrograms of misoprostol with regard to all complications associated with abortion. |
| Ethics approval(s) | Approval received from the SCRIHS (Scientific Committee for Research in Human Subjects) and local ethics committees at each participating centre. SCRIHS approved the protocol of this Project A15066 on 23/07/2001 |
| Health condition(s) or problem(s) studied | Termination of early pregnancy by vacuum aspiration |
| Intervention | Two tablets of 200 micrograms of misoprostol or two placebo tablets will be administered vaginally three hours before vacuum aspiration. Type of analgesia/anaesthesia, baseline cervical dilation, duration of procedure, amount of bleeding, complications during and after procedure, etc., will be recorded. A follow-up visit is scheduled 7 to 10 days after vacuum aspiration. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Misoprostol |
| Primary outcome measure(s) |
Complication rates in misoprostol and placebo groups, measured during the procedure, in the immediate post-operative period, and up until the follow-up visit 7 to 14 days after the procedure |
| Key secondary outcome measure(s) |
1. Ease of the procedure (dilation, duration of procedure, pain level), measured during the procedure |
| Completion date | 24/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 4984 |
| Key inclusion criteria | 1. Women requesting abortion and eligible for legal termination of normal single intrauterine pregnancy of less than 12 completed weeks (84 days) of gestation 2. Consent to participation 3. Able to understand information on the study 4. Agree to return for the scheduled follow-up visit |
| Key exclusion criteria | Women are not eligible if they have: 1. A medical condition or disease that requires special treatment, care of precautions in conjunction with vacuum aspiration 2. Allergy to misoprostol 3. Contraindications to misoprostol 4. Anaemia or any coagulation disorder |
| Date of first enrolment | 21/10/2002 |
| Date of final enrolment | 24/09/2005 |
Locations
Countries of recruitment
- Armenia
- China
- Cuba
- Hungary
- India
- Mongolia
- Romania
- Slovenia
- Switzerland
- Viet Nam
Study participating centre
Department of Reproductive Health and Research
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 |
