Condition category
Pregnancy and Childbirth
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
05/11/2014
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

Mr Kevin Harrington

ORCID ID

Contact details

Fetal Medicine Unit
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
+44 (0)20 8510 7544
kevin.harrington@virgin.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0024125765

Study information

Scientific title

Acronym

Study hypothesis

Misoprostol administered vaginally in missed miscarriage, at a dose of 800 mcg, results in expulsion (success) rates of 33-77% after 1 dose and 80-89% after 2 doses. Transcervical amnion rupture, a novel form of management, could be carried out prior to vaginal misoprostol administration to increase expulsion (success) rates. We propose to carry out a pilot randomised controlled trial (RCT) comparing vaginal misoprostol alone against transcervical amniotic puncture followed by vaginal misoprostol in the outpatient management of missed miscarriage. After consent and randomisation, subjects to be administered either vaginal misoprostol (800 mcg) or transcervical amniotic puncture performed and vaginal misoprostol administered (800 mcg) immediately after. Surgical management (evacuation of retained products of conception [ERPC]) or repeat misoprostol to be offered if no expulsion with 24 hours or heavy bleeding. Complete expulsion defined as expulsion of products of conception (POC) within 48 hours and not requiring ERPC.

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: Miscarriage

Intervention

Vaginal misoprostol (800 mcg) alone against transcervical amniotic puncture followed by vaginal misoprostol (800 mcg)

Intervention type

Drug

Phase

Not Applicable

Drug names

Misoprostol

Primary outcome measures

1. Rate of complete expulsion within 24 hr and 48 hr and time to complete expulsion
2. Number of misoprostol doses required; number requiring ERPC
3. Analgesia requirements
4. Infection rate
5. Haemoglobin change/need for blood transfusion
6. Patient satisfaction via questionnaire

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2003

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

20-40 patients with diagnosis of missed miscarriages

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2003

Recruitment end date

31/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Fetal Medicine Unit
London
E9 6SR
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Homerton University Hospital NHS Trust (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

Publication citations

Additional files

Editorial Notes