The effect of antioxidant supplementation on women with threatened miscarriage
| ISRCTN | ISRCTN68958618 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68958618 |
| Secondary identifying numbers | 03/0265 |
- Submission date
- 29/04/2004
- Registration date
- 04/06/2004
- Last edited
- 24/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
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
Contact information
Dr Jemma Johns
Scientific
Scientific
Department of Obstetrics & Gynaecology
86-96 Chenies Mews
London
WC1E 6HX
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | The effect of antioxidant supplementation on women with threatened miscarriage |
| Study acronym | TMT (Threatened Miscarriage Trial) |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Threatened Miscarriage |
| Intervention | Intervention: Vitamin C 1000 mg and Vitamin E 400 IU Control: Placebo |
| Intervention type | Supplement |
| Primary outcome measure | 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 study start date | 01/03/2004 |
| Completion date | 28/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 580 |
| Key inclusion criteria | Women who present with first trimester bleeding |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2004 |
| Date of final enrolment | 28/02/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Obstetrics & Gynaecology
London
WC1E 6HX
United Kingdom
WC1E 6HX
United Kingdom
Sponsor information
University College London Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
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
England
United Kingdom
"ROR" |
https://ror.org/042fqyp44 |
|---|
Funders
Funder type
Government
The Early Pregnancy Research Fund (0125), University College London Hospital (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 |
Editorial Notes
24/05/2016: No publications found, verifying study status with principal investigator.
