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

ISRCTN	ISRCTN21348449
DOI	https://doi.org/10.1186/ISRCTN21348449
Protocol serial number	RDC01676
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive London (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Pregnancy and childbirth: Pregnancy
Intervention	i. Expectant management ii. Surgical management
Intervention type	Other
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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.
Completion date	01/10/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/2000
Date of final enrolment	01/10/2002

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

UMDS

London
SE11 6SP
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	01/05/2004		Yes	No