Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RDC01676
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pregnancy and childbirth: Pregnancy
Intervention
i. Expectant management
ii. Surgical management
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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)
Secondary outcome measures
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.
Overall trial start date
01/10/2000
Overall trial end date
01/10/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2000
Recruitment end date
01/10/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UMDS
London
SE11 6SP
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive London (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15104611
Publication citations
-
Results
Ogden J, Maker C, Expectant or surgical management of miscarriage: a qualitative study., BJOG, 2004, 111, 5, 463-467, doi: 10.1111/j.1471-0528.2004.00121.x.