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
Secondary identifying numbers N/A
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

PO box 228
Lindi
-
Tanzania

Study information

Study designEvaluator-blinded, single-centre, randomised controlled non-inferiority trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Patient information form in Kiswahili is available on request. Please use the contact details below to request.
Scientific titleIs misoprostol a safe alternative to manual vacuum aspiration in women with early pregnancy failure in a low resource setting?: a randomized controlled trial
Study objectivesMisoprostol 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) studiedFirst trimester pregnancy failure
InterventionMisoprostol 600 microgram 3 doses (one dose every 4 hours) sublingually versus MVA
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)misoprostol
Primary outcome measureUltrasonographic endometrium thickness at day 8
Secondary outcome measuresThe following will be assessed at day 8:
1. Changes in hemoglobin (Hb) level
2. Side effects including pain
3. Adverse events
4. Patients satisfaction and acceptability

If any problem is observed on day 8, the patient will be reviewed again on day 15 (No review at day 15 if no problem is observed).
Overall study start date11/02/2008
Completion date11/02/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants180
Key inclusion criteria1. 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 criteria1. 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 enrolment11/02/2008
Date of final enrolment11/02/2009

Locations

Countries of recruitment

  • Tanzania

Study participating centre

PO box 228
Lindi
-
Tanzania

Sponsor information

Funders

Funder type

Government

Tanzanian German Program to Support Health (TGPSH) (Tanzania)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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