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 design	Evaluator-blinded, single-centre, randomised controlled non-inferiority trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Patient information form in Kiswahili is available on request. Please use the contact details below to request.
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	misoprostol
Primary outcome measure	Ultrasonographic endometrium thickness at day 8
Secondary outcome measures	The 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 date	11/02/2008
Completion date	11/02/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	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

Sponsor information

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

Lindi Office
PO box 97
Lindi
-
Tanzania

Website	http://www.tgpsh.or.tz

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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan