Out-patient management of missed miscarriage: a randomised trial of medical vs medical/minimally invasive management using transcervical amnion rupture
| ISRCTN | ISRCTN14476388 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14476388 |
| Secondary identifying numbers | N0024125765 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 02/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Mr Kevin Harrington
Scientific
Scientific
Fetal Medicine Unit
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
| Phone | +44 (0)20 8510 7544 |
|---|---|
| kevin.harrington@virgin.net |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Out-patient management of missed miscarriage: a randomised trial of medical vs medical/minimally invasive management using transcervical amnion rupture |
| Study hypothesis | The aim of this study is to compare vaginal misoprostol alone against transcervical amniotic puncture followed by vaginal misoprostol in the outpatient management of missed miscarriage. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Pregnancy and Childbirth: Miscarriage |
| Intervention | Vaginal misoprostol (800 mcg) alone against transcervical amniotic puncture followed by vaginal misoprostol (800 mcg) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Misoprostol |
| Primary outcome measure | 1. Rate of complete expulsion within 24 hr and 48 hr and time to complete expulsion 2. Number of misoprostol doses required; number requiring ERPC 3. Analgesia requirements 4. Infection rate 5. Haemoglobin change/need for blood transfusion 6. Patient satisfaction via questionnaire |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/2003 |
| Overall study end date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 40 |
| Participant inclusion criteria | 20-40 patients with diagnosis of missed miscarriages |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 01/04/2003 |
| Recruitment end date | 31/12/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Fetal Medicine Unit
London
E9 6SR
United Kingdom
E9 6SR
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Homerton University Hospital NHS Trust (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 |
Editorial Notes
02/06/2017: No publications found in PubMed, verifying study status with principal investigator
