Medical versus surgical termination of pregnancy at 13 - 20 weeks

ISRCTN	ISRCTN17262711
DOI	https://doi.org/10.1186/ISRCTN17262711
Protocol serial number	SCR2000/1
Sponsor	Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Funder	Newcastle University (UK)

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 of protocol

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

Primary study design	Interventional
Study design	Single centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled trial comparing medical versus surgical termination of pregnancy at 13 - 20 weeks
Study objectives	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)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Mifepristone, misoprotol
Primary outcome measure(s)	Impact of Event Scale (IES) at two weeks after the procedure. This 15 item scale has 7 intrusion and 8 avoidance items.
Key secondary outcome measure(s)	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
Completion date	31/01/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	130
Key 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
Key exclusion criteria	1. Foetal congenital abnormality 2. Medical disease precluding MTOP 3. Unable to speak English (less than 5% of women presenting for TOP)
Date of first enrolment	01/05/2000
Date of final enrolment	31/01/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute of Cellular Medicine

Newcastle upon Tyne
NE2 4LP
United Kingdom

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	01/11/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes