Medical versus surgical termination of pregnancy at 13 - 20 weeks

ISRCTN	ISRCTN17262711
DOI	https://doi.org/10.1186/ISRCTN17262711
Secondary identifying numbers	SCR2000/1

Submission date: 23/02/2010
Registration date: 06/04/2010
Last edited: 01/08/2012

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

Not provided at time of registration

Contact information

Prof Stephen Robson
Scientific

Institute of Cellular Medicine
3rd floor, William Leech Building
Medical School
Newcastle University
Newcastle upon Tyne
NE2 4LP
United Kingdom

Email	s.c.robson@ncl.ac.uk

Study information

Study design	Single centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised controlled trial comparing medical versus surgical termination of pregnancy at 13 - 20 weeks
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(s)	Joint Ethics Committee of the Newcastle and North Tyneside Health Authority approved on the 26th April 2000 (ref: 2000/63)
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
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Mifepristone, misoprotol
Primary outcome measure	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 study start date	01/05/2000
Overall study end date	31/01/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	130
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 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

England
United Kingdom

Study participating centre

Institute of Cellular Medicine

Newcastle upon Tyne
NE2 4LP
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

The Freeman Hospital
High Heaton
Newcastle upon Tyne
NE7 7DN
England
United Kingdom

Email	Jennifer.Walker@nuth.nhs.uk
Website	http://www.newcastle-hospitals.org.uk/
"ROR"	https://ror.org/05p40t847

Funders

Funder type

University/education

Newcastle University (UK)
Private sector organisation / Universities (academic only)

Location: United Kingdom

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	01/11/2010		Yes	No