Oral versus vaginal misoprostol for medical management of early foetal demise

Not Applicable

Completed

• Conditions: Medical management of miscarriage; Pregnancy and Childbirth; Other abnormal products of conception

• Registration Number: ISRCTN85124072
• Lead Sponsor: South Tees Hospitals NHS Trust (UK)

Brief Summary

2009 results in: https://obgyn.onlinelibrary.wiley.com/doi/abs/10.1016/S0020-7292%2809%2961912-3 (added 24/10/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2000-12-30
• Study Start: 2009-04-21
• Last Update Posted: 11 November 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 240

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinically diagnosed completion of miscarriage

Secondary Outcome Measures

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