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Oral versus vaginal misoprostol for medical management of early foetal demise

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN85124072
Enrollment
240
Registered
2009-04-21
Start date
1997-01-01
Completion date
Unknown
Last updated
2019-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 spec

Sponsors

South Tees Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Clinically diagnosed completion of miscarriage

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026