Second trimester termination of pregnancy, outcome after one or two day mifepristone-misoprostol interval

ISRCTN	ISRCTN09944151
DOI	https://doi.org/10.1186/ISRCTN09944151
Protocol serial number	0902
Sponsor	Helsinki University Hospital (Finland)
Funder	Helsinki University Hospital (Finland)

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

Helsinki University Central Hospital (HUCH)
Department of Obstetrics & Gynaecology
Haatmanninkatu 2
Helsinki
00029 HUS
Finland

Study information

Primary study design	Interventional
Study design	Randomised controlled single-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Mifepristone, misoprostol
Primary outcome measure(s)	1. Time to termination of pregnancy 2. Need for surgical curettage
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	30/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes