Randomised controlled trial of expectant, medical and surgical management of early miscarriage.

ISRCTN	ISRCTN66418282
DOI	https://doi.org/10.1186/ISRCTN66418282
Secondary identifying numbers	R/29/10.99/Smith

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Lindsay Smith
Scientific

East Somerset Research Consortium
Westlake Surgery
High Street
West Coker
BA22 9AH
United Kingdom

Phone	+44 (0)1935 862624
Email	research@esrec.nhs.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	MIST
Study objectives	Main research question: Which of three management methods (expectant, medical or surgical) of failed first trimester pregnancy (missed or incomplete miscarriage) is associated with least gynaecological infection.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Pregnancy; miscarriage
Intervention	1. Expectant management 2. Medical management 3. Surgical management
Intervention type	Other
Primary outcome measure	Gynaecological infection within 14 days of randomisation.
Secondary outcome measures	1. Bleeding & pain 2. Retained products by scan at 10-14 days 3. Depression 4. Anxiety 5. Return to normal activity 6. Complications by 6 weeks
Overall study start date	01/04/1997
Completion date	31/10/2001

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	1200 women were recruited: 399 to expectant management, 398 to medical management, and 403 to surgical management (added 12/01/10, see publication)
Key inclusion criteria	1. Women with a failed pregnancy of <13 weeks gestation 2. Attending the early pregnancy assessment clinics of Southmead Hospital, Bristol or the Royal United Hospital, Bath 3. Informed consent
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/04/1997
Date of final enrolment	31/10/2001

East Somerset Research Consortium

West Coker
BA22 9AH
United Kingdom

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

NHS Executive South West (UK)

No information available

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

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	27/05/2006	Yes	No
Other publications	economic evaluation	01/08/2006	Yes	No
Results article	results	08/10/2009	Yes	No