Is misoprostol a safe alternative to manual vacuum aspiration in women with incomplete abortions in developing countries?
| ISRCTN | ISRCTN65305620 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65305620 |
| Protocol serial number | N/A |
| Sponsor | Tanzanian German Program to Support Health (TGPSH) (Tanzania) |
| Funder | Tanzanian German Program to Support Health (TGPSH) (Tanzania) |
- Submission date
- 01/02/2008
- Registration date
- 22/02/2008
- Last edited
- 22/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Regine Unkels
Scientific
Scientific
PO box 228
Lindi
-
Tanzania
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Evaluator-blinded, single-centre, randomised controlled non-inferiority trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Is misoprostol a safe alternative to manual vacuum aspiration in women with early pregnancy failure in a low resource setting?: a randomized controlled trial |
| Study objectives | Misoprostol is just as effective as Manual Vacuum Aspiration (MVA) in treatment of first trimester pregnancy failure, but is more acceptable to clients in a rural setting in low resource countries. |
| Ethics approval(s) | The National Institute of Medical Research Dar es Salaam, approved on 18 October 2007 (ref: NIMR/HR/R.8a/Vol. IX/628) |
| Health condition(s) or problem(s) studied | First trimester pregnancy failure |
| Intervention | Misoprostol 600 microgram 3 doses (one dose every 4 hours) sublingually versus MVA |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | misoprostol |
| Primary outcome measure(s) |
Ultrasonographic endometrium thickness at day 8 |
| Key secondary outcome measure(s) |
The following will be assessed at day 8: |
| Completion date | 11/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 180 |
| Key inclusion criteria | 1. History of passage of tissue and/or blood and >30 mm endometrial thickness on TransVaginal Sonography (TVS) 2. On TVS an anembryonic gestation or fetal death with an embryonic crown-rump length between 5 and 62 mm without cardiac activity (in case of a Crown-Rump Length [CRL] of 5-9 mm TVS will be repeated after one week to ensure absence of cardiac activity) or an anembryonic gestational sac of 16-45 mm (TVS will be repeated after one week to ensure growth of the gestational sac is <3 mm and exclude a viable pregnancy) |
| Key exclusion criteria | 1. On TVS present fetal heart activity, a crown-rump length >62 mm, molar pregnancy or a endometrial thickness less than or equal to 30 mm 2. Fundal height of more than halfway the umbilicus and the symphysis indicating a gestational age >12 weeks 3. Known allergy to prostaglandins 4. Heavy blood loss or a pulse rate of >120/min 5. Axillary temperature of > 38°C or signs of septic abortion such as pus draining from uterus 6. Ectopic pregnancy |
| Date of first enrolment | 11/02/2008 |
| Date of final enrolment | 11/02/2009 |
Locations
Countries of recruitment
- Tanzania
Study participating centre
PO box 228
Lindi
-
Tanzania
-
Tanzania
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
