title: Institutionalizing postpartum intrauterine device (IUD) services in Sri Lanka, Tanzania, and Nepal: study protocol for a cluster-randomized stepped-wedge trial.
abstract: During the year following the birth of a child, 40% of women are estimated to have an unmet need for contraception. The copper IUD provides safe, effective, convenient, and long-term contraceptive protection that does not interfere with breastfeeding during the postpartum period. Postpartum IUD (PPIUD) insertion should be performed by a trained provider in the early postpartum period to reduce expulsion rates and complications, but these services are not widely available. The International Federation of Obstetricians and Gynecologists (FIGO) will implement an intervention that aims to institutionalize PPIUD training as a regular part of the OB/GYN training program and to integrate it as part of the standard practice at the time of delivery in intervention hospitals.
  
  
  
  This trial uses a cluster-randomized stepped wedge design to assess the causal effect of the FIGO intervention on the uptake and continued use of PPIUD and of the effect on subsequent pregnancy and birth. This trial also seeks to measure institutionalization of PPIUD services in study hospitals and diffusion of these services to other providers and health facilities. This study will also include a nested mixed-methods performance evaluation to describe intervention implementation.
  
  
  
  This study will provide critical evidence on the causal effects of hospital-based PPIUD provision on contraceptive choices and reproductive health outcomes, as well as on the feasibility, acceptability and longer run institutional impacts in three low- and middle-income countries.
  
  
  
  Trial registered on March 11, 2016 with ClinicalTrials.gov, NCT02718222 .
authors.affiliation: Department of Global Health and Population, Harvard T. H. Chan School of Public Health, Boston, USA.
authors.forename: David
authors.initials: D
authors.lastname: Canning
authors.affiliation: Department of Global Health and Population, Harvard T. H. Chan School of Public Health, Boston, USA.
authors.forename: Iqbal H
authors.initials: IH
authors.lastname: Shah
authors.affiliation: Department of Global Health and Population, Harvard T. H. Chan School of Public Health, Boston, USA. epearson@hsph.harvard.edu.
authors.forename: Erin
authors.identifier: 0000-0001-6264-9970
authors.initials: E
authors.lastname: Pearson
authors.affiliation: Department of Global Health and Population, Harvard T. H. Chan School of Public Health, Boston, USA.
authors.forename: Elina
authors.initials: E
authors.lastname: Pradhan
authors.affiliation: Department of Global Health and Population, Harvard T. H. Chan School of Public Health, Boston, USA.
authors.forename: Mahesh
authors.initials: M
authors.lastname: Karra
authors.affiliation: Department of Global Health and Population, Harvard T. H. Chan School of Public Health, Boston, USA.
authors.forename: Leigh
authors.initials: L
authors.lastname: Senderowicz
authors.affiliation: Department of Global Health and Population, Harvard T. H. Chan School of Public Health, Boston, USA.
authors.forename: Till
authors.initials: T
authors.lastname: Bärnighausen
authors.affiliation: Department of Global Health and Population, Harvard T. H. Chan School of Public Health, Boston, USA.
authors.forename: Donna
authors.initials: D
authors.lastname: Spiegelman
authors.affiliation: Department of Global Health and Population, Harvard T. H. Chan School of Public Health, Boston, USA.
authors.forename: Ana
authors.initials: A
authors.lastname: Langer
mesh_terms: D000328:Adult; D002985:Clinical Protocols; D016000:Cluster Analysis; D003267:Contraception / Q000379:methods*; D005193:Family Planning Services / Q000379:methods / Q000458:organization & administration*; D005260:Female; D006284:Health Plan Implementation / Q000379:methods*; D006761:Hospitals; D006801:Humans; D007434:Intrauterine Devices; D009390:Nepal; D016134:Organizational Policy; D011181:Postnatal Care / Q000379:methods / Q000458:organization & administration*; D011247:Pregnancy; D015397:Program Evaluation / Q000379:methods; D013188:Sri Lanka; D013636:Tanzania
keywords: IUD; Impact evaluation; Postpartum contraception