Condition category
Pregnancy and Childbirth
Date applied
29/04/2004
Date assigned
04/06/2004
Last edited
24/05/2016
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 Jemma Johns

ORCID ID

Contact details

Department of Obstetrics & Gynaecology
86-96 Chenies Mews
London
WC1E 6HX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

03/0265

Study information

Scientific title

The effect of antioxidant supplementation on women with threatened miscarriage

Acronym

TMT (Threatened Miscarriage Trial)

Study hypothesis

Not provided at time of registration

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

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Threatened Miscarriage

Intervention

Intervention: Vitamin C 1000 mg and Vitamin E 400 IU
Control: Placebo

Intervention type

Supplement

Phase

Not Specified

Drug names

Vitamin C and E

Primary outcome measures

Incidence of miscarriage, late miscarriage and pre-term labour.

Secondary outcome measures

Incidence of pre-term pre-labour rupture of the membranes, fetal growth restriction and pre-eclampsia.

Overall trial start date

01/03/2004

Overall trial end date

28/02/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Women who present with first trimester bleeding

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

580

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/03/2004

Recruitment end date

28/02/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Obstetrics & Gynaecology
London
WC1E 6HX
United Kingdom

Sponsor information

Organisation

University College London Hospitals NHS Trust (UK)

Sponsor details

UCLH/UCL Research & Development Governance Committee
Research and Development Directorate
University College London Hospitals NHS Trust
1st Floor
Maple House
149 Tottenham Court Road
London
W1P 9LL
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

The Early Pregnancy Research Fund (0125), University College London Hospital (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

24/05/2016: No publications found, verifying study status with principal investigator.