Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT06327646

Maternal Adherence to MMS in Nepal

Sponsor: Helen Keller International

View on ClinicalTrials.gov

Summary

Although clinical studies highlight the value of MMS for pregnant and lactating women, implementation research studies are necessary to understand adherence and acceptability to the product and to uncover potential obstacles to implementation in specific contexts. For Nepal, it is crucial to establish whether adherence to MMS supplementation is non-inferior to the existing IFA supplementation for 180 tablets, which has a high (65%) adherence rate. It is also important to investigate how whether providing MMS in bottles (containing a substantial quantity, such as 90 count bottles twice during pregnancy) might impact ANC utilization, particularly in terms of ensuring that pregnant women attend at least eight ANC visits. Furthermore, assessment of MMS acceptability, including pill taste, smell, size, swallowability, side effects, benefits as well as aspects such as product labeling and packaging, among end users in Nepal, is needed to understand acceptability of MMS vs. IFA. Finally, implementation issues within the health system, including the need of trainings for healthcare workers' and, female community health volunteers (FCHVs)' training needs; and government stakeholders' interest and barriers;; community s Social and behavioral change communication needs, and issues around supply chain issues should be well-understood and documented to inform prior to scale-up to support a smooth transition of MMS. Thus, Helen Keller International, in collaboration with Nepal's Ministry of Health and Population (MoHP) and the Eleanor Crook Foundation (ECF), will conduct a set of four mixed-methods studies to generate evidence and insights that inform the development of an MMS supplementation strategy. This trial in one province of Nepal is the first study that will be complemented by one additional quantitative study and two qualitative studies to generate evidence on the topics mentioned.

Official title: Non-inferiority Assessment of Maternal Adherence to Supplementation: a Trial on the Effects of MMS

Key Details

Gender

FEMALE

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

2640

Start Date

2024-07-04

Completion Date

2025-09

Last Updated

2025-01-28

Healthy Volunteers

Yes

Conditions

Supplementation

Interventions

DRUG

Multiple Micronutrient Supplement Blister

MMS in a blister pack along with related job aids, counselling during ANC, etc.

DRUG

Multiple Micronutrient Supplement Bottle

MMS in bottles along with related job aids, counselling during ANC, etc.

DRUG

Iron Folic Acid Blister

Standard of Care - IFA in a blister pack along with related job aids, counselling during ANC, etc.

Locations (119)

Thada primary health care centre

Arghakhanchi, Lumbini Province, Nepal

Khairapur health post

Bardiyā, Lumbini Province, Nepal

Mathura haridwar health post

Bardiyā, Lumbini Province, Nepal

Motipur health post

Bardiyā, Lumbini Province, Nepal

Neulapur health Post

Bardiyā, Lumbini Province, Nepal

Sanoshree health post

Bardiyā, Lumbini Province, Nepal

Banakatawa primary health care centre

Bānke, Lumbini Province, Nepal

Banakatti health post

Bānke, Lumbini Province, Nepal

Basudevapur health post

Bānke, Lumbini Province, Nepal

Bejapur health post

Bānke, Lumbini Province, Nepal

Belahari health post

Bānke, Lumbini Province, Nepal

Betahani health post

Bānke, Lumbini Province, Nepal

Chisapani health post

Bānke, Lumbini Province, Nepal

Ganapur health post

Bānke, Lumbini Province, Nepal

Gangapur health post

Bānke, Lumbini Province, Nepal

Hirminiya health post

Bānke, Lumbini Province, Nepal

Holiya health post

Bānke, Lumbini Province, Nepal

Indrapur health post

Bānke, Lumbini Province, Nepal

Jaispur health post

Bānke, Lumbini Province, Nepal

Kalaphata health post

Bānke, Lumbini Province, Nepal

Kathkuiya health post

Bānke, Lumbini Province, Nepal

Khajura primary health care centre

Bānke, Lumbini Province, Nepal

Khaskarkado health post

Bānke, Lumbini Province, Nepal

Laxmanpur primary health care centre

Bānke, Lumbini Province, Nepal

Matahiya health post

Bānke, Lumbini Province, Nepal

Narainapur health post

Bānke, Lumbini Province, Nepal

Phattepur health post

Bānke, Lumbini Province, Nepal

Puraina health post

Bānke, Lumbini Province, Nepal

Puraini health post

Bānke, Lumbini Province, Nepal

Rainyapur health post

Bānke, Lumbini Province, Nepal

Saigaun Health Post

Bānke, Lumbini Province, Nepal

Sonpur health post

Bānke, Lumbini Province, Nepal

Titihiriya health post

Bānke, Lumbini Province, Nepal

Udarapur health post

Bānke, Lumbini Province, Nepal

Udayapur health post

Bānke, Lumbini Province, Nepal

Gadhawa Health Post

Dāng, Lumbini Province, Nepal

Hapur Health Post

Dāng, Lumbini Province, Nepal

Lalmatiya Health Post

Dāng, Lumbini Province, Nepal

Laxmipur Health Post

Dāng, Lumbini Province, Nepal

Satbariya Health Post

Dāng, Lumbini Province, Nepal

Shantinagar Health Post

Dāng, Lumbini Province, Nepal

Sisahaniya Health Post

Dāng, Lumbini Province, Nepal

Aama Health Post