Mumbai Maternal Nutrition Project
| ISRCTN | ISRCTN62811278 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62811278 |
| Protocol serial number | 074048 |
| Sponsor | Centre for the Study of Social Change (India) |
| Funders | Wellcome Trust, Parthenon Trust, ICICI Ltd (Mumbai), The United States Agency for International Development (USAID)/The International Life Sciences Institute (ILSI) (USA) |
- Submission date
- 11/01/2006
- Registration date
- 11/01/2006
- Last edited
- 27/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Caroline Fall
Scientific
Scientific
MRC Epidemiology Resource Centre
Southampton General Hospital
University of Southampton
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)2380 777624 |
|---|---|
| chdf@mrc.soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Mumbai Maternal Diet Study: randomised controlled trial of micronutrient-dense food before and during pregnancy to prevent low birthweight |
| Study acronym | Project Saras |
| Study objectives | Supplementation of women with a food-based micronutrient-rich supplement for at least three months prior to conception, and throughout pregnancy, will reduce the incidence of low birthweight, reduce infant mortality, and improve functional outcomes in the children, including growth, neuro-cognitive function and cardiovascular disease risk factors. |
| Ethics approval(s) | 1. UK: Southampton and South West Hampshire Local Research Ethics Committee, 13/01/2003, ref: 377/02/t 2. Mumbai: BYL Nair and TN Medical College Ethics Committee, 17/09/2002 |
| Health condition(s) or problem(s) studied | Pregnancy outcome and infant mortality |
| Intervention | Women who are not pregnant, but are planning to have further children, will be recruited and randomised to one of four groups, to receive one of two interventions: a daily food-based supplement made from vegetables, fruit, and milk, of differing micronutrient content. Supplementation will be supervised. Field staff will record menstrual dates, in order to detect pregnancy as early as possible. Women who become pregnant will have investigations during pregnancy, including blood samples and ultrasound scans. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
1. Birthweight |
| Key secondary outcome measure(s) |
1. Maternal micronutrient status |
| Completion date | 31/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 4000 |
| Total final enrolment | 6513 |
| Key inclusion criteria | 1. Women living in slum communities in Bandra and Khar districts of Mumbai served by the Women of India Network (WIN) primary health care clinics 2. Women who wish to join 3. Married 4. Aged 15 to 35 years 5. Not pregnant at recruitment 6. Not using any PERMANENT form of contraception 7. Intending to have more children 8. Planning any future deliveries in Mumbai |
| Key exclusion criteria | 1. Women living outside the study area 2. Non-married women 3. Women outside the age range specified 4. Women currently pregnant (these may become eligible after delivery) 5. Women who have undergone sterilisation surgery, or whose husbands have had a vasectomy 6. Women definitely not planning further pregnancies 7. Women definitely planning further deliveries outside Mumbai |
| Date of first enrolment | 09/01/2006 |
| Date of final enrolment | 30/06/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
- India
Study participating centre
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
SO16 6YD
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2014 | Yes | No | |
| Results article | results | 01/07/2016 | Yes | No | |
| Results article | results | 01/07/2019 | 14/04/2020 | Yes | No |
| Results article | Follow up results | 07/01/2022 | 12/01/2022 | Yes | No |
| Results article | 18/02/2023 | 27/03/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/03/2023: Publication reference added.
12/01/2022: Publication reference added.
14/04/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the 2014 reference.
10/06/2016: Publication reference added.
