Condition category
Pregnancy and Childbirth
Date applied
26/02/2009
Date assigned
21/04/2009
Last edited
09/09/2016
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 Elaine Gouk

ORCID ID

Contact details

University Hospital of North Tees
Hardwick Road
Stockton-on-Tees
Cleveland
TS19 8PE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial of oral versus vaginal misoprostol for medical management of early foetal demise

Acronym

Study hypothesis

When used in conjunction with oral mifepristone (200 mg), a single dose of vaginal misoprostol (800 micrograms) has a higher success rate in treating early foetal demise than an oral regimen of misoprostol (600/400/400 micrograms).

Ethics approval

South Tees Hospital Trust Ethics Committee, 23/09/1997, ref: 97/69

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Medical management of miscarriage

Intervention

In both groups, oral mifeprostone (200 mg) was given and then the misoprotol administered 48 hours later. The vaginal regimen was given once only. If no products were passed/seen, even on vaginal speculum examination, this could be repeated the next day. The oral regime (600/400/400 micrograms) was given at two hourly intervals. Again, if the miscarriage had not completed, this could be reviewed the next day.

Intervention type

Drug

Phase

Not Specified

Drug names

Mifepristone, misoprostol

Primary outcome measures

Clinically diagnosed completion of miscarriage

Secondary outcome measures

1. Parity, assessed at initial presentation
2. Anembryonic/embryonic early foetal demise assessed at time of ultrasound scan and miscarriage diagnosis
3. Side effects (pain, diarrhoea, vomiting), assessed during treatment and inpatient stay
4. Analgesia use

Overall trial start date

01/01/1997

Overall trial end date

30/12/2000

Reason abandoned

Eligibility

Participant inclusion criteria

Women with an ultrasound diagnosis of (singleton) early foetal demise, with no medical contraindications or known allergy to misoprostol or mifepristone.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

240

Participant exclusion criteria

1. Heavy smokers (of >20 cigarettes day)
2. Aged >35 years
3. Severe asthma
4. Cardiovascular disease, hypertension (blood pressure [BP] >160/100 mmHg)
5. Chronic adrenal, renal or hepatic failure
6. Porphyria or haemorrhagic disorders
7. Long term corticosteroid
8. Anticoagulant or non-steroidal anti-inflammatory drug (NSAID) therapy
9. Known allergy to mifepristone or misoprostol

Recruitment start date

01/01/1997

Recruitment end date

30/12/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital of North Tees
Stockton-on-Tees, Cleveland
TS19 8PE
United Kingdom

Sponsor information

Organisation

South Tees Hospitals NHS Trust (UK)

Sponsor details

The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.southtees.nhs.uk/live/

Funders

Funder type

Hospital/treatment centre

Funder name

The James Cook University Hospital (UK)

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

09/09/2016: No publications found in PubMed, verifying study status with principal investigator.