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Effect of community-based pre-conception care package on maternal and child health outcomes

Evaluating the effect of community-based pre-conception care package through trained nurses on pre-conception health, maternal and child health outcomes: a stepped-wedge cluster randomized implementation trial. - EPIC

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064582
Enrollment
3200
Registered
2024-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Comprehensive community-based Pre-conception care package: The intervention would consist of implementing a comprehensive PCC package through PCC clinics in the villages through trained

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Only those who give written informed consent for participation in trial will be included in the study. 2. Only those women who are permanent resident of the village and willing to stay in the study area for the next two years will be included

Exclusion criteria

Exclusion criteria: 1. The eligible couples wherein either of the partner have adopted any permanent method of contraception will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Improvement in Pre-conception health among women from eligible couple as ascertained by the proportion of women who would enter pregnancy in good health without undernutrition, anaemia and depression.Timepoint: Five time points every six monthly starting after six months of intervention with endline conducted at 36 months. Beyond these a baseline assessment will be conducted.

Secondary

MeasureTime frame
The secondary outcomes include improved maternal & child health outcomes, such as reductions in stillbirth rate, neonatal mortality rate (NMR), infant mortality rate (IMR), & severe maternal morbidities (e.g., pre-eclampsia, gestational diabetes, maternal depression, hemorrhage, & abortion). Other outcomes include lower rates of low birth weight, stunting at age one, delayed first pregnancies, longer birth intervals, & more planned pregnancies.Timepoint: A cohort of potential beneficiaries will be followed from conception through pregnancy outcomes & until the child turns one year old for live births. ;The secondary outcomes include examining the factors that facilitate or hinder the implementation & use of the PCC package, assessing the feasibility of the intervention using the RE-AIM framework, & estimating the unit cost of delivering community-based PCC services accounting for direct, indirect, & opportunity costs, aiding future policy advocacy for the PCC package. In addition, sub-clinical parameters related to anemia, including serum ferritin & vitamin B12 levels, will be measured.Timepoint: Implementation outcomes & cost of implementation will be estimated through endline survey & barrier analysis at 36 months Biochemical profiling will be conducted on a subsample of 1,920 individuals (640 each) at baseline, an interim survey 3 at 18 months, & endline.

Countries

India

Contacts

Public ContactDr Anuj Mundra

Mahatma Gandhi Institute of Medical Sciences, Sevagram

ashwini@mgims.ac.in7440977777

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026