Main
|
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: |
|
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
|
Source(s) of Monetary Support
|
National Academy of Sciences
|
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:
|
|
|
|