Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05708183 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Healthy Mums, Healthy Babies: Multiple Micronutrient Supplementation in Ethiopia

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 12, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Active, Not Recruiting to Recruitingv3 Show 6 more changesShow less
    • Primary completion date: Apr 15, 2023 to Dec 31, 2024
    • Study sites: 1 to 6
    • Study completion date: Feb 28, 2025 to Aug 31, 2025
    • Start date: Jan 15, 2023 to Jan 1, 2023
    • Study description shortened, about 24 words
    • Eligibility criteria shortened, about 1 word
  2. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Primary completion date: Mar 15, 2023 to Apr 15, 2023
    • Start date changed from estimate of Feb 1, 2023 to Jan 15, 2023
    • Site contact updated
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: This programme effectiveness study responds to the need for evidence on the effect on birthweight of switching from iron-folic acid supplementation (IFA) to multiple micronutrient supplementation (MMS) as part of routine antenatal care in Ethiopia. A 2019 meta-analysis of trial data reported a mean improvement of 35g in newborn birthweight amongst newborns born to women who took MMS in pregnancy compared to those who took IFA. Responding to this evidence, in 2020 the World Health Organisation updated its global guideline on MMS from 'not recommended' to 'recommended in the context of rigorous research'. The guideline identifies priority research being 'to establish the impact of switching routine antenatal IFA to MMS on important health outcomes, equity, acceptability, feasibility, sustainability and health-care resources in different country settings.' In 2022 the Ministry of Health of Ethiopia (MoH), will change from MMS to IFA in a set of pilot districts. EPHI and LSHTM have been asked to evaluate the effect of this change on mean birthweight and propose the current trial for this purpose. The overall aim is to evaluate the programme effectiveness on mean birthweight of providing MMS as part of routine antenatal care, compared to providing IFA. Findings will support the MoH to make evidence-informed decisions about the large-scale implementation of MMS in Ethiopia and also contribute to the global evidence base on the effectiveness of MMS in a programmatic setting. Methods: A two-arm cluster randomized trial will be used to estimate the effect of the programme change on mean birthweight, with cost-effectiveness and process evaluations embedded in the trial design. Women aged 15-49 who deliver a live born child in a study district health facility (mother/infant dyads) will be eligible for enrolment in the study. The primary outcome measure will be birthweight, recorded in facilities at the time of birth as part of the routine maternity care. Secondary objectives include costs of providing MMS, acceptability of MMS, adherence to antenatal micronutrient supplementation and implementation challenges.
Trial Details
NCT Number NCT05708183
Lead Sponsor London School of Hygiene and Tropical Medicine
Collaborators: Ethiopian Public Health Institute
Conditions
(from sponsor)		 Birth Weight
Related terms Birth Weight
Enrollment 25,620 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov