Second trimester termination of pregnancy, outcome after one or two day mifepristone-misoprostol interval
| ISRCTN | ISRCTN09944151 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09944151 |
| Secondary identifying numbers | 0902 |
- Submission date
- 13/10/2008
- Registration date
- 16/01/2009
- Last edited
- 04/01/2013
- 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 Oskari Heikinheimo
Scientific
Scientific
Helsinki University Central Hospital (HUCH)
Department of Obstetrics & Gynaecology
Haatmanninkatu 2
Helsinki
00029 HUS
Finland
Study information
| Study design | Randomised controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet (in Finnish and Swedish) |
| Scientific title | Second trimester termination of pregnancy, outcome after one or two day mifepristone-misoprostol interval: a randomised controlled trial |
| Study objectives | The combined regimen of mifepristone and misoprostol can be used at one day or two day interval without losing effectiveness. |
| Ethics approval(s) | Ethics Committee of the Helsinki University Hospital, Department of Obstetrics and Gynaecology, approved on 01/10/2007 (ref: HUS 244/E9/07) |
| Health condition(s) or problem(s) studied | Termination of second trimester pregnancy |
| Intervention | The study is a prospective, randomised, single-centre study of about 150 patients seeking a second trimester termination of pregnancy at Helsinki University Hospital during 01/06/2008-31/06/2009. The participating patients will be randomised into two groups, having misoprostol (vaginally, or orally in cases of heavy uterine bleeding) either 20-28 or 40-48 hours after mifepristone (oral). The dose of mifepristone is single (200 mg) and misoprostol 0.4 mg doses will be given in 3-4 hours interval up to 5 times, until the abortion occurs. The patients will have a check-up after 2-4 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Mifepristone, misoprostol |
| Primary outcome measure | 1. Time to termination of pregnancy 2. Need for surgical curettage |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/06/2008 |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Approximately 150-200 |
| Key inclusion criteria | 1. Age over 18 years 2. Duration of pregnancy (as verified by ultrasonography) between 12 weeks (12+1) up to 24 weeks (24+0) and approval for termination from the Finnish National Authority for Medico-legal Affairs (TEO) 3. Singleton, live pregnancy 4. Voluntary participation and signed approval to the study 5. No intrauterine device (IUD) in utero at the time of abortion |
| Key exclusion criteria | 1. Allergy to mifepristone or misoprostol 2. Severe, complicated asthma 3. An extrauterine pregnancy 4. No common language with the investigators 5. A coronary disease or high risk factors for it 6. HIV or hepatitis (a smaller group having blood samples taken) |
| Date of first enrolment | 01/06/2008 |
| Date of final enrolment | 30/06/2009 |
Locations
Countries of recruitment
- Finland
Study participating centre
Helsinki University Central Hospital (HUCH)
Helsinki
00029 HUS
Finland
00029 HUS
Finland
Sponsor information
Helsinki University Hospital (Finland)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Oskari Heikinheimo
Department of Obstetrics and Gynaecology
Haartmaninkatu 2
PB 140
Helsinki
00029 HUS
Finland
| Website | http://www.hus.fi/ |
|---|---|
"ROR" |
https://ror.org/02e8hzf44 |
Funders
Funder type
Hospital/treatment centre
Helsinki University Hospital (Finland)
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 | 01/08/2012 | Yes | No |
