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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	11 November 2019
Main ID:	ISRCTN85124072
Date of registration:	21/04/2009
Prospective Registration:	No
Primary sponsor:	South Tees Hospitals NHS Trust (UK)
Public title:	Oral versus vaginal misoprostol for medical management of early foetal demise
Scientific title:	A randomised controlled trial of oral versus vaginal misoprostol for medical management of early foetal demise
Date of first enrolment:	01/01/1997
Target sample size:	240
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN85124072
Study type:	Interventional
Study design:	Randomised controlled trial (Treatment)
Phase:	Not Specified

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Elaine Gouk
Address:	University Hospital of North Tees Hardwick Road TS19 8PE Stockton-on-Tees, Cleveland United Kingdom
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Medical management of miscarriage
Pregnancy and Childbirth
Other abnormal products of conception

Intervention(s)

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.

Primary Outcome(s)

Clinically diagnosed completion of miscarriage

Secondary Outcome(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

The James Cook University Hospital (UK)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

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

Results

Results available:	Yes
Date Posted:
Date Completed:	30/12/2000
URL:

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