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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 24 February 2020
Main ID:  ISRCTN25743783
Date of registration: 31/01/2017
Prospective Registration: No
Primary sponsor: Georgia State University
Public title: Saving maternal and infant lives with affordable technology
Scientific title: Affordable technology to serve rural women across literacy barriers to save maternal and infant lives
Date of first enrolment: 01/05/2015
Target sample size: 1556
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN25743783
Study type:  Interventional
Study design:  Cluster randomised trial (Prevention)  
Phase:  Not Applicable
Countries of recruitment
Pakistan
Contacts
Name: Musharraf    Cyan
Address:  Georgia State University Andrew Young School of Policy Studies International Center for Public Policy 14 Marietta Street 30300 Atlanta United States of America
Telephone: +1 404 413 0244
Email: cyan@gsu.edu
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria:
1. Pregnant women
2. In the first trimester of pregnancy
3. Within the randomly chosen areas within 10 unions of 2 districts of Pakistan

Exclusion criteria:
1. In the second or third trimester of pregnancy
2. Non-pregnant women


Age minimum:
Age maximum:
Gender: Female
Health Condition(s) or Problem(s) studied
Preventable maternal and infant mortality that occurs because of complications during pregnancy.
Pregnancy and Childbirth
Preventable maternal and infant mortality that occurs because of complications during pregnancy.
Intervention(s)

Current intervention as of 27/01/2020:
Discrepancies in the protocol and registry were corrected with a protocol revision submitted to
our IRB on 1-05-14. In the final tally, our subjects received a total of 110 messages (52 before
delivery; 52 after delivery; 6 based on symptoms and complications.
372 participating villages of 2 districts of Pakistan are randomized to one of five groups. Women
in the first trimester of pregnancy are recruited through a house to house survey for
participation in the study. Participation is voluntary and is obtained using approved and standard
informed consent procedures.
Intervention group 1: Women receive two telemessages per week timed with pregnancy and infant care stages.
Intervention group 2: Women receive one telemessage per week timed with pregnancy and
infant care stages.
Intervention group 3: Women receive one telemessage per week without any particular timing
with pregnancy and postpartum stages but in random order to mimic public media messages.
Intervention group 4: Women receive one telemessage per week timed with pregnancy and
infant care stages plus phone balance transfers if additional information accessed.
Control group: Women receive traditional health communication only.
In all groups, the treatment is applied over a period of 18 months. For the intervention groups,
the telemessaging includes general and specific guidance on hygiene and maternal and infant
nutrition, nutritional supplements, use of antenatal care and w
Primary Outcome(s)
Adoption of skilled birth attendance is measured using a survey designed for the purpose of this study and reviewing clinical notes at baseline and 18 months.
Secondary Outcome(s)

1. Adoption of specialist care upon referral is measured using a survey designed for the purpose of this study and reviewing clinical notes at baseline and 18 months
2. Gains in health literacy is measured using a survey designed for the purpose of this study and reviewing clinical notes at baseline and 18 months
3. Vaccination rates of infants at 12 months of age is measured using a survey designed for the purpose of this study and reviewing clinical notes at baseline and 18 months
Secondary ID(s)
H14050
Source(s) of Monetary Support
National Academy of Sciences
Secondary Sponsor(s)
King Edward Medical University
Ethics review
Status:
Approval date:
Contact:
Susan Laury Experimental Economics Center, Shelia L. White Office of Research Integrity, Georgia State University, 06/02/2015, ref: 331936
Results
Results available: Yes
Date Posted:
Date Completed: 03/02/2018
URL:
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