Oral versus vaginal misoprostol for medical management of early foetal demise
| ISRCTN | ISRCTN85124072 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85124072 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/02/2009
- Registration date
- 21/04/2009
- Last edited
- 24/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Elaine Gouk
Scientific
Scientific
University Hospital of North Tees
Hardwick Road
Stockton-on-Tees, Cleveland
TS19 8PE
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | A randomised controlled trial of oral versus vaginal misoprostol for medical management of early foetal demise |
| Study objectives | 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(s) | South Tees Hospital Trust Ethics Committee, 23/09/1997, ref: 97/69 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Mifepristone, misoprostol |
| Primary outcome measure | 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 study start date | 01/01/1997 |
| Completion date | 30/12/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 240 |
| Key inclusion criteria | Women with an ultrasound diagnosis of (singleton) early foetal demise, with no medical contraindications or known allergy to misoprostol or mifepristone. |
| Key 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 |
| Date of first enrolment | 01/01/1997 |
| Date of final enrolment | 30/12/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Hospital of North Tees
Stockton-on-Tees, Cleveland
TS19 8PE
United Kingdom
TS19 8PE
United Kingdom
Sponsor information
South Tees Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
England
United Kingdom
| Website | http://www.southtees.nhs.uk/live/ |
|---|---|
"ROR" |
https://ror.org/02js17r36 |
Funders
Funder type
Hospital/treatment centre
The James Cook University Hospital (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2009 | 24/10/2019 | Yes | No |
Editorial Notes
24/10/2019: Publication reference added.
09/09/2016: No publications found in PubMed, verifying study status with principal investigator.
