A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: the ACT cluster-randomised trial.

ALTHABE F; BELIZAN JM; MCCLURE E; HEMINGWAY-FODAY J; BERRUETA M; MAZZONI A; CIGANDA A; GOUDAR S; KODKANY BS; MAHANTSHETTI N; DHADED SM; KATAGERI GM; METGUD MC; JOSHI AM; BELLAD MB; HONNUNGAR NV; DERMAN RJ; SALEEM S; PASHA O; ALI S; HARNAIN F; GOLDENBERG RL; ESAMAI F; NYONGESA P; AYUNGA S; LIECHTY EA; GARCES AL; FIGUEROA L; HAMBIDGE KM; KREBS NF; PATEL A; BHANDARKAR A; WAIKAR M; HIBBERD PL; CHOMBA E; CARLO WA; MWICHE A; CHIWILA M; MANASYAN A; PINEDA S; MELETH S; THORSTEN V; STOLKA K; WALLACE DD; KOSO-THOMAS M; BUEKENS P

LANCET

ELSEVIER SCIENCE INC

Lugar: Amsterdam; Año: 2015

0140-6736

AbstractBACKGROUND:Antenatal corticosteroids for pregnant women at risk of preterm birth are among the most effective hospital-based interventions to reduce neonatal mortality. We aimed to assess the feasibility, effectiveness, and safety of a multifaceted intervention designed to increase the use of antenatal corticosteroids at all levels of health care in low-income and middle-income countries.METHODS:In this 18-month, cluster-randomised trial, we randomly assigned (1:1) rural and semi-urban clusters within six countries (Argentina, Guatemala, India, Kenya, Pakistan, and Zambia) to standard care or a multifaceted intervention including components to improve identification of women at risk of preterm birth and to facilitate appropriate use of antenatal corticosteroids. The primary outcome was 28-day neonatal mortality among infants less than the 5th percentile for birthweight (a proxy for preterm birth) across the clusters. Use of antenatal corticosteroids and suspected maternal infection were additional main outcomes. This trial is registered with ClinicalTrials.gov, number NCT01084096.FINDINGS:The ACT trial took place between October, 2011, and March, 2014 (start dates varied by site). 51 intervention clusters with 47,394 livebirths (2520 [5%] less than 5th percentile for birthweight) and 50 control clusters with 50,743 livebirths (2258 [4%] less than 5th percentile) completed follow-up. 1052 (45%) of 2327 women in intervention clusters who delivered less-than-5th-percentile infants received antenatal corticosteroids, compared with 215 (10%) of 2062 in control clusters (p