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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4467

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710049
        • Xi'an Jiaotong University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Good household prenatal practice
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.
Behavioral: Care seeking
  • Danger-sign recognition
  • Reminders for government projects
Experimental: Full bank of SMS
This arm receives the SMS messages delivered to the GHPP, CS and control group.
Behavioral: Full bank of SMS
  • Danger-sign recognition
  • Reminders for government projects
  • Knowledge on nutrition, labor, non-medical pain management, breastfeeding and depression
No Intervention: Control

Control group receives SMS messages regarding:

  • Reminders of prenatal visits and certified skilled attendance of labor (status quo);
  • Fetal development in different gestational stages.

The three experimental groups receive the control messages as well.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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:

  1. Duration of folic acid
  2. Uptake of infant vaccinations
In the duration of pregnancy, an expected average of 9 months, and 1 month after birth
C-section rate
Time Frame: child birth
child birth
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harvard School of Public Health (HSPH)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Health Science Center of Xi'an Jiaotong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • newborn2013

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