Condition category
Pregnancy and Childbirth
Date applied
23/01/2017
Date assigned
31/01/2017
Last edited
31/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Pakistan has one of the highest rates of maternal and infant deaths in the world. A possible reason for this may be that fewer than half of these women have a skilled birth attendant, such as a doctor or midwife, present when they are giving birth. Health surveys in Pakistan have shown that around 18 percent of pregnant women develop complications in pregnancy. Complications can lead to a higher risk of illness or death of the mother and/or baby, and the presence of skilled birth attendance (SBA) is the best way of minimizing these risks. Using mobile phone voice messages (telemessaging) to provide information about the importance of SBA, as well as how women should look after themselves and their baby during pregnancy and after they have given birth could help to improve survival rates. The aim of this study is to look at the effectiveness of a telemessaging service to help improve maternal and infant health outcomes.

Who can participate?
Women in their first trimester of pregnancy living within participating areas in Pakistan.

What does the study involve?
Participating women are randomly allocated to one of five groups. Those in the first four groups receive telemessaging, which provides information about using health services, nutrition, signs of pregnancy complications to look out for and vaccination. Those in the first group receive 130 messages timed with stages of pregnancy and after giving birth, those in the second group receive 78 messages without any particular timing, those in the thirst group receive 78 messages timed with stages of pregnancy and after giving birth, and those in the fourth group receive 78 messages plus phone balance transfers if additional information is accessed. Those in the fifth group receive traditional health communication which does not involve receiving extra voice messages. At the start of the study and after 12 months, participants complete a survey and have their medical records reviewed to see what healthcare services they have used.

What are the possible benefits and risks of participating?
Women who receive the messages benefit from receiving information and guidance during their pregnancy which could help lower the risk of death or illness for themselves and their new baby’s. There are no notable risks involved with participating.

Where is the study run from?
The study is run from King Edward Medical University and takes place in randomly chosen areas within 10 unions of 2 districts (Pakistan)

When is the study starting and how long is it expected to run for?
August 2014 to February 2018

Who is funding the study?
National Academy of Sciences (USA)

Who is the main contact?
Dr Musharraf Cyan
cyan@gsu.edu

Trial website

Contact information

Type

Public

Primary contact

Dr Musharraf Cyan

ORCID ID

Contact details

Georgia State University
Andrew Young School of Policy Studies
International Center for Public Policy
14 Marietta Street
Atlanta
30300
United States of America
+1 404 413 0244
cyan@gsu.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

H14050

Study information

Scientific title

Affordable technology to serve rural women across literacy barriers to save maternal and infant lives

Acronym

Study hypothesis

The aim of this study is to test whether health messages linked to progression through pregnancy and six months postpartum that are delivered in female voices directly to the pregnant woman by cellphone have a statistically significant effect on maternal and infant mortality.

Ethics approval

Susan Laury Experimental Economics Center, Shelia L. White Office of Research Integrity, Georgia State University, 06/02/2015, ref: 331936

Study design

Cluster randomised trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Preventable maternal and infant mortality that occurs because of complications during pregnancy.

Intervention

411 participating villages of 2 districts of Pakistan are randomised 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 telemessaging with frequency of 130 messages timed with pregnancy and infant care stages.
Intervention group 2: Women receive telemessaging with frequency of 78 messages time with pregnancy and infant care stages.
Intervention group 3: Women receive telemessaging with frequency of 78 messages not timed with pregnancy and postpartum stages but in random oder to mimic public media messages.
Intervention group 4: Women receive telemessaging with 78 timed messages 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 why and when necessary, monthly pregnancy checklists for the age of pregnancy, recognition of signs of pregnancy complications (especially pre-eclampsia and eclampsia), vaccination.

At baseline and after 18 months, a survey is carried out to record hygiene and nutrition practices, use of antenatal care, skilled birth attendance and postnatal care. The survey also inquires about households health outcomes especially those of the mother and the infant.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

01/08/2014

Overall trial end date

03/02/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1556

Participant exclusion criteria

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

Recruitment start date

01/05/2015

Recruitment end date

30/10/2016

Locations

Countries of recruitment

Pakistan

Trial participating centre

King Edward Medical University
Nelagumbad Mayo Hospital Road
Lahore
54000
Pakistan

Sponsor information

Organisation

Georgia State University

Sponsor details

33 Gilmer St SE
Atlanta
30302
United States of America

Sponsor type

University/education

Website

http://www.gsu.edu

Organisation

King Edward Medical University

Sponsor details

Nelagumbad
Mayo Hospital Road
Lahore
54000
Pakistan
+92 42 99211145
info@kemu.edu.pk

Sponsor type

University/education

Website

http://kemu.edu.pk

Funders

Funder type

Charity

Funder name

National Academy of Sciences

Alternative name(s)

NAS

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal in 6 months.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Musharraf Cyan (cyan@gsu.edu)

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes