Short Message ServiceSMSNCT02037087
The Impact of Prenatal Short Messages (SMS) on Maternal and Newborn Health
A study testing Good household prenatal practice, Care seeking and Full bank of SMS in people with Short Message Service and Text Messaging, run by Harvard School of Public Health (HSPH) at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Short Message Service, Text Messaging
- What is being tested?
- Good household prenatal practice, Care seeking and Full bank of SMS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,467 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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?
- Conditions
- Short Message Service, Text Messaging
- Being tested
- Good household prenatal practice, Care seeking, Full bank of SMS
- Keywords
- Short Message Service, newborn health, maternal behavior, good household pregnancy practice, care seeking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Good household prenatal practiceBehavioural
Knowledge on nutrition, labor, non-medical pain management, breastfeeding and depression
Care seekingBehavioural
- Danger-sign recognition
- Reminders for government projects
Full bank of SMSBehavioural
- Danger-sign recognition
- Reminders for government projects
- Knowledge on nutrition, labor, non-medical pain management, breastfeeding and depression
| Study group | Role | What they receive |
|---|---|---|
| Good household prenatal practice (GHPP) | Experimental | 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. Receives: Behavioral: Good household prenatal practice |
| Care seeking (CS) | Experimental | 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. Receives: Behavioral: Care seeking |
| Full bank of SMS | Experimental | This arm receives the SMS messages delivered to the GHPP, CS and control group. Receives: Behavioral: Full bank of SMS |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Newborn health
Newborn health is measured by appropriateness of weight for gestational age.
Measured: the first month after birth
Secondary outcomes (7)
Neonatal Adverse Outcome Indicator (NAOI)
The NAOI focuses on measuring severe neonatal morbidity.
Measured: the first month after birth
Actual number of prenatal visits over expected visits
Measured: In the duration of pregnancy, an expected average of 9 months
Uptake of government-subsidized programs
This outcome is measured by the following metrics:
- Duration of folic acid
- Uptake of infant vaccinations
Measured: In the duration of pregnancy, an expected average of 9 months, and 1 month after birth
C-section rate
Measured: child birth
Maternal health
Maternal health is measured by change of perception in general health and postpartum depression.
Measured: Child birth and 1 year after birth
Near-miss
The near-miss focuses on measuring severe maternal morbidity.
Measured: In the duration of pregnancy, an expected average of 9 months, and childbirth
Psychological outcomes
Attitudes, personal norms, self-efficacy, social desirability, intentions, plans, susceptibility, expectations, and severity
Measured: In the duration of pregnancy, an expected average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startSep 2013
- Primary completionOct 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Short Message ServiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4,467 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Xi'an Jiaotong University
- Responsible party
- Principal investigator, Yanfang Su, Harvard School of Public Health (HSPH)
- Investigators
- Yanfang Su, MA, Principal investigator, Harvard School of Public Health (HSPH)Zhongliang Zhou, PhD, Principal investigator, Xi'an Jiaotong UniversityChangzheng Yuan, MS, Principal investigator, Harvard School of Public Health (HSPH)Jesse Heitner, MPP, Principal investigator, Harvard School of Public Health (HSPH)Benjamin Campbell, BA, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037087
- Sponsor's protocol ID
- newborn2013
- Acronym
- SMS
- Status last verified
- Apr 2016
- First submitted
- 14 Jan 2014
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 33141099Su 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.
PubMed 27515750
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Prenatal Short Messages on Maternal and Newborn Health
- ClinicalTrials.gov ID
- NCT02037087
- Acronym / sponsor ID
- SMS / newborn2013
- Conditions
- Short Message Service, Text Messaging
- Keywords
- Short Message Service, newborn health, maternal behavior, good household pregnancy practice, care seeking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,467 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Xi'an Jiaotong University
- Study start
- Sep 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Good household prenatal practice (GHPP) | Experimental | Behavioral: Good household prenatal practiceThe 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. |
| Care seeking (CS) | Experimental | Behavioral: Care seekingThe 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. |
| Full bank of SMS | Experimental | Behavioral: Full bank of SMSThis arm receives the SMS messages delivered to the GHPP, CS and control group. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Good household prenatal practiceKnowledge on nutrition, labor, non-medical pain management, breastfeeding and depression | Behavioural | Good household prenatal practice (GHPP) |
| Care seeking* Danger-sign recognition * Reminders for government projects | Behavioural | Care seeking (CS) |
| Full bank of SMS* Danger-sign recognition * Reminders for government projects * Knowledge on nutrition, labor, non-medical pain management, breastfeeding and depression | Behavioural | Full bank of SMS |
Primary outcome
Newborn health
Time frame: the first month after birth
Newborn health is measured by appropriateness of weight for gestational age.
7 secondary outcomes
Neonatal Adverse Outcome Indicator (NAOI)
Time frame: 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
Uptake of government-subsidized programs
Time frame: In the duration of pregnancy, an expected average of 9 months, and 1 month after birth
C-section rate
Time frame: child birth
Maternal health
Time frame: Child birth and 1 year after birth
Near-miss
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
- Derived from this study: PubMed 33141099Su 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.
- Derived from this study: PubMed 27515750Su 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.
Related trials for Short Message Service
Recruiting
Colorectal Cancer Screening in the Homeless
Colorectal Cancer
RecruitingObservational study
The Medacta International SMS Post-Marketing Surveillance Study
Arthrosis, Traumatic Arthritis
Not yet recruitingPhase 1/2
A Study to Investigate Small Mobile Stem Cells (SMS) in Moderate to Severe Chronic Obstructive Pulmonary Disease
Chronic Obstructive Lung Disease
RecruitingObservational study
Multicentre SMS Study - FR
Dysplasia of Hip Joint, Hip Osteoarthritis
Recruiting
Right-Size Clinic Visits Using Memora Platform for PROMIS
Orthopedic Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanfang Su, MA principal investigator
Harvard School of Public Health (HSPH)
Zhongliang Zhou, PhD principal investigator
Xi'an Jiaotong University
Changzheng Yuan, MS principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Good household prenatal practice, Care seeking and Full bank of SMS in people with Short Message Service and Text Messaging, run by Harvard School of Public Health (HSPH) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newborn health (time frame: the first month after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02037087, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2016.