Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
14/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jane Ogden

ORCID ID

Contact details

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

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15104611

Publication citations

  1. 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.

Additional files

Editorial Notes