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Enrolling by invitation NCT05703373

Increasing Access to Multiple Micronutrient Supplementation - A Pilot Intervention at up to 15 Clinics in Botswana

No phase Interventional Pregnancy Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multiple Micronutrient Supplement.
Who it may be relevant to
Registry conditions: Pregnancy Related. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Botswana
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The purpose of this study is to pilot a clinic-level supplementation intervention at up to 15 antenatal clinics throughout Botswana. The overall objective of this study is to improve access to and uptake of MMS among pregnant women in Botswana. The investigators will evaluate both implementation outcomes (adoption, penetration, fidelity, and feasibility) and clinical outcomes (adverse birth outcomes, weight gain in pregnancy, and anemia) through linkage with the Tsepamo birth outcomes surveillance study.

Interventions

  • Dietary supplement Multiple Micronutrient Supplement
    Multiple micronutrient supplementation (MMS) which includes iron, folic acid, and additional micronutrients,

Primary outcome measures

  • Proportion with first supplement filled by MMS [Time frame: 6-month intervention period]
Secondary outcome measures (6)
  • Implementation: Proportion for which MMS is filled [Time frame: 6-month intervention period]
  • Implementation: Proportion for which first and second supplement filled by MMS [Time frame: 6-month intervention period]
  • Implementation: Feasibility [Time frame: 8 months]
  • Clinical: Number of Pregnant Women with an Adverse Birth Outcome [Time frame: 6-months]
  • Clinical: Weight Gain in Pregnancy [Time frame: 6-months]
  • Clinical: Number of mothers diagnosed with Maternal Anemia [Time frame: 6-months]

Eligibility criteria

Inclusion criteria

  • Pregnant women attending interventional antenatal clinics during the 6-month study

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Botswana · 13 centers
  • Kgatelopele (Block 8) — Block 8
  • Gabarone West Clinic — Gaborone
  • Lesirane Clinic — Gaborone
  • Mahlaku Lekganyane (Mmopane Block 1) — Gaborone
  • Nkoyaphiri Clinic — Gaborone
  • Tlokweng Main Clinic — Gaborone
  • Kopong Clinic — Kopong
  • Borakalalo — Molepolole
  • … and 5 more centers

Identifiers

NCT: NCT05703373 · 852412

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗