- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02037087
The Impact of Prenatal Short Messages (SMS) on Maternal and Newborn Health (SMS)
April 6, 2016 updated by: Yanfang Su, Harvard School of Public Health (HSPH)
The Impact of Prenatal Short Messages on Maternal and Newborn Health
It is hypothesized that delivering short messages (SMS) to pregnant women can improve maternal and newborn health outcomes.
This pilot offers mothers-to-be in rural China free daily short messages (SMS) via cell phone.
The aim is to advise them on (a) good household prenatal practices (GHPP) and (b) care seeking (CS) in order to improve the quality of life for mothers and newborns.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Factorial quasi-randomization is utilized to compare two groups of interventions (i.e., GHPP and CS) as well as to compare these individual interventions with a combination of the interventions.
It is also possible that distinct treatments have interaction effects, and we plan to test for this.
Policymakers are interested in using different strategies to enhance neonatal health.
For example, the bank of SMS developed by our team is a combination of several components: reminders for regular checkups, information on GHPP, and information on CS.
From a policy perspective, the evaluation of the full bank of SMS may be sufficient for the government to decide whether or not to scale up the full bank of SMS.
However, to understand maternal behavior and, for policy purposes, to understand which components in the bank of SMS should be scaled up, it is important to disentangle which component contributes most to final neonatal health.
Taken together, are all the components of the bank of SMS effective in changing maternal behavior and enhancing neonatal health?
Which mechanisms are at play, good household prenatal care, care seeking in pregnancy, or both?
Study Type
Interventional
Enrollment (Actual)
4467
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shaanxi
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Xi'an, Shaanxi, China, 710049
- Xi'an Jiaotong University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
There were two inclusion criteria: Local pregnant women must 1) own a cell phone in the household, and 2) visit a MCHC for antenatal care during pregnancy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Good household prenatal practice (GHPP)
The GHPP arm receives SMS messages regarding knowledge on nutrition, labor, non-medical pain management, breastfeeding, and depression.
This arm also receives messages delivered to the control group.
|
Knowledge on nutrition, labor, non-medical pain management, breastfeeding and depression
|
|
Experimental: Care seeking (CS)
The CS arm receives SMS messages which include danger-sign recognition and reminders for government-subsidized projects.
This arm also receives messages delivered to the control group.
|
|
|
Experimental: Full bank of SMS
This arm receives the SMS messages delivered to the GHPP, CS and control group.
|
|
|
No Intervention: Control
Control group receives SMS messages regarding:
The three experimental groups receive the control messages as well. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Newborn health
Time Frame: the first month after birth
|
Newborn health is measured by appropriateness of weight for gestational age.
|
the first month after birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neonatal Adverse Outcome Indicator (NAOI)
Time Frame: the first month after birth
|
The NAOI focuses on measuring severe neonatal morbidity.
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the first month after birth
|
|
Actual number of prenatal visits over expected visits
Time Frame: In the duration of pregnancy, an expected average of 9 months
|
In the duration of pregnancy, an expected average of 9 months
|
|
|
Uptake of government-subsidized programs
Time Frame: In the duration of pregnancy, an expected average of 9 months, and 1 month after birth
|
This outcome is measured by the following metrics:
|
In the duration of pregnancy, an expected average of 9 months, and 1 month after birth
|
|
C-section rate
Time Frame: child birth
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child birth
|
|
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Maternal health
Time Frame: Child birth and 1 year after birth
|
Maternal health is measured by change of perception in general health and postpartum depression.
|
Child birth and 1 year after birth
|
|
Near-miss
Time Frame: In the duration of pregnancy, an expected average of 9 months, and childbirth
|
The near-miss focuses on measuring severe maternal morbidity.
|
In the duration of pregnancy, an expected average of 9 months, and childbirth
|
|
Psychological outcomes
Time Frame: In the duration of pregnancy, an expected average of 9 months
|
Attitudes, personal norms, self-efficacy, social desirability, intentions, plans, susceptibility, expectations, and severity
|
In the duration of pregnancy, an expected average of 9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yanfang Su, MA, Harvard School of Public Health (HSPH)
- Principal Investigator: Zhongliang Zhou, PhD, Health Science Center of Xi'an Jiaotong University
- Principal Investigator: Changzheng Yuan, MS, Harvard School of Public Health (HSPH)
- Principal Investigator: Jesse Heitner, MPP, Harvard School of Public Health (HSPH)
- Principal Investigator: Benjamin Campbell, BA, Dartmouth College
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Su Y, Heitner J, Yuan C, Si Y, Wang D, Zhou Z, Zhou Z. Effect of a Text Messaging-Based Educational Intervention on Cesarean Section Rates Among Pregnant Women in China: Quasirandomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Nov 3;8(11):e19953. doi: 10.2196/19953.
- Su Y, Yuan C, Zhou Z, Heitner J, Campbell B. Impact of an SMS advice programme on maternal and newborn health in rural China: study protocol for a quasi-randomised controlled trial. BMJ Open. 2016 Aug 10;6(8):e011016. doi: 10.1136/bmjopen-2015-011016.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
January 14, 2014
First Submitted That Met QC Criteria
January 14, 2014
First Posted (Estimate)
January 15, 2014
Study Record Updates
Last Update Posted (Estimate)
April 7, 2016
Last Update Submitted That Met QC Criteria
April 6, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- newborn2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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