Out-patient management of missed miscarriage: a randomised trial of medical vs medical/minimally invasive management using transcervical amnion rupture

ISRCTN	ISRCTN14476388
DOI	https://doi.org/10.1186/ISRCTN14476388
Protocol serial number	N0024125765
Sponsor	Department of Health
Funder	Homerton University Hospital NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr Kevin Harrington
Scientific

Fetal Medicine Unit
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom

Phone	+44 (0)20 8510 7544
Email	kevin.harrington@virgin.net

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Out-patient management of missed miscarriage: a randomised trial of medical vs medical/minimally invasive management using transcervical amnion rupture
Study objectives	The aim of this study is to compare vaginal misoprostol alone against transcervical amniotic puncture followed by vaginal misoprostol in the outpatient management of missed miscarriage.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Misoprostol
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2003

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	40
Key inclusion criteria	20-40 patients with diagnosis of missed miscarriages
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/04/2003
Date of final enrolment	31/12/2003

Fetal Medicine Unit

London
E9 6SR
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

02/06/2017: No publications found in PubMed, verifying study status with principal investigator