Condition category
Pregnancy and Childbirth
Date applied
01/02/2008
Date assigned
22/02/2008
Last edited
22/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Regine Unkels

ORCID ID

Contact details

PO box 228
Lindi
-
Tanzania

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

The National Institute of Medical Research Dar es Salaam, approved on 18 October 2007 (ref: NIMR/HR/R.8a/Vol. IX/628)

Study design

Evaluator-blinded, single-centre, randomised controlled non-inferiority trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Patient information form in Kiswahili is available on request. Please use the contact details below to request.

Condition

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 names

misoprostol

Primary outcome measures

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 trial start date

11/02/2008

Overall trial end date

11/02/2009

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

180

Participant 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

Recruitment start date

11/02/2008

Recruitment end date

11/02/2009

Locations

Countries of recruitment

Tanzania

Trial participating centre

PO box 228
Lindi
-
Tanzania

Sponsor information

Organisation

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

Sponsor details

Lindi Office
PO box 97
Lindi
-
Tanzania

Sponsor type

Government

Website

http://www.tgpsh.or.tz

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes