Low Birthweight
Conditions
Interventions
Current interventions as of 12/08/2021:
RANDOMIZATION
After a participant has consented, a study nurse will open a sequential, numbered sealed opaque envelope containing the allocation, and the partic
Sponsors
Brigham and Women's Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women <=24 weeks gestation with a viable pregnancy based on a best clinical algorithm (LMP and/or symphysis fundal height)
Exclusion criteria
Exclusion criteria: 1. Pregnant women presenting with non-viable fetus 2. Women who do not intend to deliver in the study catchment area 3. Women who refuse to provide consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Birth weight: Mean infant weight (g) among live born infants measured <72 hour of delivery 2. Birth length: Mean infant length (cm) among live born infants measured <72 hours of delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gestational age: Mean gestational age, measured using ultrasound, at delivery 2. Preterm birth: Proportion of pregnancies resulting in spontaneous birth <37 weeks’ gestation among all births, measured using birth assessment, at birth 3. Small-for-gestational age (SGA): Proportions of newborns born SGA (<10% birthweight for gestational age and sex) among live born infants whose birthweight if measured within 72 hours of delivery, measured using digital infant scales, at birth 4. Low birthweight: Proportion of newborns born with weight <2500 g among liveborn infants whose weight is measured within 72 hours of delivery, measured using digital infant scales, at birth 5. Length-for-age: Mean Length-for-age Z scores at birth and 6 months of age among live born infants based on the WHO growth reference standards, measured using infant length boards, at birth 6. Weight-for-age: Mean Weight-for-age Z scores at birth and 6 months of age among live born infants based on the WHO growth reference standards, measured using digital infant scales, at birth 7. Rate of weight gain in pregnancy: Maternal weight gain (kg) per week gestation in the 2nd and 3rd trimester, measured using digital maternal scales, from date of first 2nd trimester antenatal care (ANC) visit until date of last ANC visit before birth, assessed up to 6 months 8. Maternal anemia: Mean hemoglobin concentration, using Mission Hb or similar hemoglobin devices, at the third trimester antenatal care visit (28-40 weeks’ gestation) 9. Stillbirth: Rate of stillbirths per 1000 births, measured using maternal assessment, throughout the study period 10. UTI: Maternal clinically diagnosed urinary tract infection (cystitis, pyelonephritis) reported in medical records in 3rd trimester 11. Maternal endometritis or puerperal sepsis measured by clinical diagnosis in medical records at or within 42 days after birth | — |
Countries
Ethiopia
Contacts
Public ContactAnne;Krysten Lee;North
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Outcome results
None listed