The effect of antioxidant supplementation on women with threatened miscarriage
| ISRCTN | ISRCTN68958618 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68958618 |
| Protocol serial number | 03/0265 |
| Sponsor | University College London Hospitals NHS Trust (UK) |
| Funder | The Early Pregnancy Research Fund (0125), University College London Hospital (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Incidence of miscarriage, late miscarriage and pre-term labour. |
| Key secondary outcome measure(s) |
Incidence of pre-term pre-labour rupture of the membranes, fetal growth restriction and pre-eclampsia. |
| Completion date | 28/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of Obstetrics & Gynaecology
London
WC1E 6HX
United Kingdom
WC1E 6HX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/05/2016: No publications found, verifying study status with principal investigator.
