A pragmatic randomised controlled trial of expectant versus surgical management of first trimester spontaneous miscarriage

ISRCTN ISRCTN21348449
DOI https://doi.org/10.1186/ISRCTN21348449
Secondary identifying numbers RDC01676
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
14/10/2014
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

Dr Jane Ogden
Scientific

UMDS
Dept of General Practice
80 Kennington Road
London
SE11 6SP
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectives1. 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPregnancy and childbirth: Pregnancy
Interventioni. Expectant management
ii. Surgical management
Intervention typeOther
Primary outcome measure1. 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 measuresClinical 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 study start date01/10/2000
Completion date01/10/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/10/2000
Date of final enrolment01/10/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UMDS
London
SE11 6SP
United Kingdom

Sponsor information

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

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

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive London (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2004 Yes No