title: Implementation of evidence-based antenatal care in Mozambique: a cluster randomized controlled trial: study protocol.
abstract: BACKGROUND
  Antenatal care (ANC) reduces maternal and perinatal morbidity and mortality directly through the detection and treatment of pregnancy-related illnesses, and indirectly through the detection of women at increased risk of delivery complications. The potential benefits of quality antenatal care services are most significant in low-resource countries where morbidity and mortality levels among women of reproductive age and neonates are higher.WHO developed an ANC model that recommended the delivery of services scientifically proven to improve maternal, perinatal and neonatal outcomes. The aim of this study is to determine the effect of an intervention designed to increase the use of the package of evidence-based services included in the WHO ANC model in Mozambique. The primary hypothesis is that the intervention will increase the use of evidence-based practices during ANC visits in comparison to the standard dissemination channels currently used in the country.
  
  
  METHODS
  This is a demonstration project to be developed through a facility-based cluster randomized controlled trial with a stepped wedge design. The intervention was tailored, based on formative research findings, to be readily applicable to local prenatal care services and acceptable to local pregnant women and health providers. The intervention includes four components: the provision of kits with all necessary medicines and laboratory supplies for ANC (medical and non-medical equipment), a storage system, a tracking system, and training sessions for health care providers. Ten clinics were selected and will start receiving the intervention in a random order. Outcomes will be computed at each time point when a new clinic starts the intervention. The primary outcomes are the delivery of selected health care practices to women attending the first ANC visit, and secondary outcomes are the delivery of selected health care practices to women attending second and higher ANC visits as well as the attitude of midwives in relation to adopting the practices. This demonstration project is pragmatic in orientation and will be conducted under routine conditions.
  
  
  CONCLUSIONS
  There is an urgent need for effective and sustainable scaling-up approaches of health interventions in low-resource countries. This can only be accomplished by the engagement of the country's health stakeholders at all levels. This project aims to achieve improvement in the quality of antenatal care in Mozambique through the implementation of a multifaceted intervention on three levels: policy, organizational and health care delivery levels. The implementation of the trial will probably require a change in accountability and behaviour of health care providers and we expect this change in 'habits' will contribute to obtaining reliable health indicators, not only related to research issues, but also to health care outcomes derived from the new health care model. At policy level, the results of this study may suggest a need for revision of the supply chain management system. Given that supply chain management is a major challenge for many low-resource countries, we envisage that important lessons on how to improve the supply chain in Mozambique and other similar settings, will be drawn from this study.
  
  
  BACKGROUND
  Pan African Clinical Trial Registry database. Identification number: PACTR201306000550192.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Chavane
authors.forename: Mario
authors.initials: M
authors.lastname: Merialdi
authors.affiliation: Department of Reproductive Health Research, World Health Organization, Geneva, Switzerland. betrana@who.int.
authors.forename: Ana Pilar
authors.initials: AP
authors.lastname: Betrán
authors.forename: Jennifer
authors.initials: J
authors.lastname: Requejo-Harris
authors.forename: Eduardo
authors.initials: E
authors.lastname: Bergel
authors.forename: Alicia
authors.initials: A
authors.lastname: Aleman
authors.forename: Mercedes
authors.initials: M
authors.lastname: Colomar
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Cafferata
authors.forename: Alicia
authors.initials: A
authors.lastname: Carbonell
authors.forename: Beatrice
authors.initials: B
authors.lastname: Crahay
authors.forename: Therese
authors.initials: T
authors.lastname: Delvaux
authors.forename: Diederike
authors.initials: D
authors.lastname: Geelhoed
authors.forename: Metin
authors.initials: M
authors.lastname: Gülmezoglu
authors.forename: Celsa Regina
authors.initials: CR
authors.lastname: Malapende
authors.forename: Armando
authors.initials: A
authors.lastname: Melo
authors.forename: My Huong
authors.initials: MH
authors.lastname: Nguyen
authors.forename: Nafissa Bique
authors.initials: NB
authors.lastname: Osman
authors.forename: Mariana
authors.initials: M
authors.lastname: Widmer
authors.forename: Marleen
authors.initials: M
authors.lastname: Temmerman
authors.forename: Fernando
authors.initials: F
authors.lastname: Althabe
mesh_terms: D003906:Developing Countries; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D009073:Mozambique; D011203:Poverty; D011247:Pregnancy; D011248:Pregnancy Complications / Q000517:prevention & control; D011295:Prenatal Care; D016730:Program Development