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ISRCTN
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ISRCTN21348449
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ClinicalTrials.gov identifier
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Public title
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A pragmatic randomised controlled trial of expectant versus surgical management of first trimester spontaneous miscarriage
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Scientific title
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Acronym
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N/A
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Serial number at source
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RDC01676
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Study hypothesis
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1. Surgical management will be more effective than expectant management in bringing about the complete resolution of pregnancy as measured at one week follow up using the transvaginal ultrasound scan.
2. Expectant management will be associated with less infective morbidity than surgical management.
3. Expectant management and surgical management of miscarriage will result in similar clinical outcomes in term of pain, bleeding, convalescence time and fertility.
4. Surgical management will result in greater psychological morbidity than expectant management although no definite predictions of the magnitude of difference can be made.
5. Expectant management will be more cost effective than surgical management.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Pregnancy and childbirth: Pregnancy
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Participants - inclusion criteria
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1. Positive urine pregnancy test
2. Clinical symptoms of miscarriage (vaginal bleeding, lower abdominal pain)
3. Ultrasound evidence of retained placental tissue
4. Gestation age less than 13 weeks
5. Written informed consent given
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/10/2000
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Anticipated end date
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01/10/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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i. Expectant management
ii. Surgical management
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Primary outcome measure(s)
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1. Clinical Outcomes: Complete resolution of pregnancy will be defined as absence of vaginal bleeding and no evidence of products of conception on the ultrasound scan. The attending clinicians will be blind to the treatment received by the patient.
2. Psychological outcomes. Patients will complete measures of: psychological morbidity (anxiety, depression, somatic symptoms and insomnia) subjective health status, individual quality of life, acceptability and satisfaction with the intervention, adjustment of miscarriage using the Perinatal Grief Scale (Thoedter et al, 1988)
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Secondary outcome measure(s)
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Clinical Outcomes - secondary:
1. Completed by the research nurse: blood pressure and temperature, haemoglobin and white cell count.
2. Completed by the patient: pain (intensity), bleeding (duration and quantity), convalescence time (days), fertility.
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Sources of funding
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NHS Executive London (UK)
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Trial website
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Publications
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1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15104611
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Contact name
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Dr
Jane
Ogden
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Address
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UMDS
Dept of General Practice
80 Kennington Road
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City/town
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London
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Zip/Postcode
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SE11 6SP
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Country
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United Kingdom
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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15/08/2011
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Date ISRCTN assigned
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23/01/2004
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