Condition category
Pregnancy and Childbirth
Date applied
13/10/2008
Date assigned
16/01/2009
Last edited
04/01/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Oskari Heikinheimo

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0902

Study information

Scientific title

Second trimester termination of pregnancy, outcome after one or two day mifepristone-misoprostol interval: a randomised controlled trial

Acronym

Study hypothesis

The combined regimen of mifepristone and misoprostol can be used at one day or two day interval without losing effectiveness.

Ethics approval

Ethics Committee of the Helsinki University Hospital, Department of Obstetrics and Gynaecology, approved on 01/10/2007 (ref: HUS 244/E9/07)

Study design

Randomised controlled single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (in Finnish and Swedish)

Condition

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 names

Mifepristone, misoprostol

Primary outcome measures

1. Time to termination of pregnancy
2. Need for surgical curettage

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/06/2008

Overall trial end date

30/06/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Approximately 150-200

Participant 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)

Recruitment start date

01/06/2008

Recruitment end date

30/06/2009

Locations

Countries of recruitment

Finland

Trial participating centre

Helsinki University Central Hospital (HUCH)
Helsinki
00029 HUS
Finland

Sponsor information

Organisation

Helsinki University Hospital (Finland)

Sponsor details

c/o Dr Oskari Heikinheimo
Department of Obstetrics and Gynaecology
Haartmaninkatu 2
PB 140
Helsinki
00029 HUS
Finland

Sponsor type

Hospital/treatment centre

Website

http://www.hus.fi/

Funders

Funder type

Hospital/treatment centre

Funder name

Helsinki University Hospital (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22240172

Publication citations

  1. Results

    Mentula M, Heikinheimo O, Risk factors of surgical evacuation following second-trimester medical termination of pregnancy., Contraception, 2012, 86, 2, 141-146, doi: 10.1016/j.contraception.2011.11.070.

Additional files

Editorial Notes