Patel, Archana
Prakash, Amber Abhijeet
Pusdekar, Yamini V.
Kulkarni, Hemant
Hibberd, Patricia
Funding for this research was provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (U01HD058322, U01HD078439)
Article History
Received: 4 August 2016
Accepted: 11 September 2017
First Online: 19 September 2017
Ethics approval and consent to participate
: The MNH Registry study and ACT Trial in Nagpur, India were reviewed and approved at The Lata Medical Research Foundation Institutional Review Board (FWA00012971) and the Partners Human Research Committee, Boston, MA. A Data Monitoring Committee appointed by NICHD reviews the MNH Registry data at least annually. The MNH Registry and ACT Trial were registered at ExternalRef removed (MNH Registry – NCT01073475; ACT Trial – NCT01084096).
: Pregnant women intending to deliver in the study communities or affiliated hospitals were informed about the study and invited to participate in the MNH registry and enrolled if they consented and signed the MNH IRB approved, written informed consent form. Women living in the communities randomized to the ACT intervention were invited to participate in the ACT trial and enrolled if they signed the ACT IRB approved written consent form.
: The authors declare that they have no competing interests.
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