Condition category
Pregnancy and Childbirth
Date applied
23/02/2010
Date assigned
06/04/2010
Last edited
01/08/2012
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

Prof Stephen Robson

ORCID ID

Contact details

Institute of Cellular Medicine
3rd floor
William Leech Building
Medical School
Newcastle University
Newcastle upon Tyne
NE2 4LP
United Kingdom
s.c.robson@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SCR2000/1

Study information

Scientific title

A randomised controlled trial comparing medical versus surgical termination of pregnancy at 13 - 20 weeks

Acronym

Study hypothesis

Compared to surgical termination of pregnancy (STOP), medical termination of pregnancy (MTOP) would be associated with greater psychological distress at 2 weeks after the procedure, as measured by the Impact of Events Scale (IES) at 13 - 20 weeks gestation.

Ethics approval

Joint Ethics Committee of the Newcastle and North Tyneside Health Authority approved on the 26th April 2000 (ref: 2000/63)

Study design

Single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Termination of unwanted pregnancy

Intervention

Women randomised to STOP:
All nulliparous women and multiparous women greater than 17 weeks' gestation were primed with Gemeprost 1 mg vaginally 3 and 6 hours prior to the anticipated time of STOP. Multiparous women between 13+0 and 16+6 weeks were primed with Gemeprost 1 mg vaginally 3 hours prior to the anticipated time of STOP. All STOPs were performed under general anaesthesia by one experienced surgeon. Cases between 13+0 and 14+6 vacuum aspiration was performed Cases greater than or equal to 15+0 weeks dilatation and evacuation was performed.

Women randomised to MTOP:
Women were given mifepristone 200 mg orally. 36 - 48 hours later misoprostol 800 µg was administered vaginally followed by 400 µg vaginally or orally (depending on amount of vaginal bleeding) every 3 hours up to a maximum of 4 doses. If abortion had not occurred by midnight a further dose of mifepristone 200 mg orally was administered followed by gemeprost 1 mg vaginally 3 hourly from 0800 hours up to a maximum of 5 doses. If abortion had still not occurred by 0800 hours the following morning the MTOP was deemed to have failed and STOP arranged.

All women received periabortion antibiotic prophylaxis with doxycycline 100 mg orally twice daily, commencing on the day prior to abortion. Women having STOP also received metronidazole 1 g rectally at the time of abortion. All women were invited back for follow up at two weeks post-procedure.

Intervention type

Drug

Phase

Phase IV

Drug names

Mifepristone, misoprotol

Primary outcome measures

Impact of Event Scale (IES) at two weeks after the procedure. This 15 item scale has 7 intrusion and 8 avoidance items.

Secondary outcome measures

1. Clinical effectiveness of procedure, measured at two weeks post-procedure
2. Complications, measured at two weeks post-procedure
3. Procedure specific symptoms, measured at two weeks post-procedure
4. Acceptability, measured at two weeks post-procedure
5. General health Questionnaire-12 item (GHQ-12), measured at baseline and two weeks post-procedure
6. Hospital Anxiety and Depression Scale (HADS), measured at baseline and two weeks post-procedure
7. Satisfaction with care received before during and after procedure (excellent/very good/good/fair/poor), measured at two weeks post-procedure

Overall trial start date

01/05/2000

Overall trial end date

31/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women accepted for termination of pregnancy (TOP) under clause C of the Human Fertilisation and Embryology Act (1990) amendment of the Abortion Act (1967)
2. Pregnancies between 13+0 and 19+6 weeks' gestation at the time of abortion
3. Aged over 16 years; women under 16 years of age were eligible for inclusion if deemed Fraser competent by the clinical practitioner and where a parent or guardian was present and also willing to give written consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

130

Participant exclusion criteria

1. Foetal congenital abnormality
2. Medical disease precluding MTOP
3. Unable to speak English (less than 5% of women presenting for TOP)

Recruitment start date

01/05/2000

Recruitment end date

31/01/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Cellular Medicine
Newcastle upon Tyne
NE2 4LP
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

The Freeman Hospital
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Jennifer.Walker@nuth.nhs.uk

Sponsor type

Government

Website

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

University/education

Funder name

Newcastle University (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

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. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20860598

Publication citations

  1. Results

    Kelly T, Suddes J, Howel D, Hewison J, Robson S, Comparing medical versus surgical termination of pregnancy at 13-20 weeks of gestation: a randomised controlled trial., BJOG, 2010, 117, 12, 1512-1520, doi: 10.1111/j.1471-0528.2010.02712.x.

Additional files

Editorial Notes