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
Scientific
UMDS
Dept of General Practice
80 Kennington Road
London
SE11 6SP
United Kingdom
Study information
| 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 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 | 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 study start date | 01/10/2000 |
| Completion date | 01/10/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
UMDS
London
SE11 6SP
United Kingdom
SE11 6SP
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2004 | Yes | No |
