The Impact of Prenatal Short Messages (SMS) on Maternal and Newborn Health

Text Messaging Clinical Trial

— SMS  

Official title:

The Impact of Prenatal Short Messages on Maternal and Newborn Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037087
• Other study ID #: newborn2013
• Status: Completed
• Phase: N/A
• First received: January 14, 2014
• Last updated: April 6, 2016
• Start date: September 2013
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4467
• Est. completion date: March 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Short Message Service
• Text Messaging

Intervention

Behavioral:
• Good household prenatal practice
Knowledge on nutrition, labor, non-medical pain management, breastfeeding and depression
• Care seeking
Danger-sign recognition Reminders for government projects
• Full bank of SMS
Danger-sign recognition Reminders for government projects Knowledge on nutrition, labor, non-medical pain management, breastfeeding and depression

Locations

Country	Name	City	State
China	Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Xi’an Jiaotong University College of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Newborn health	Newborn health is measured by appropriateness of weight for gestational age.	the first month after birth	No
Secondary	Neonatal Adverse Outcome Indicator (NAOI)	The NAOI focuses on measuring severe neonatal morbidity.	the first month after birth	No
Secondary	Actual number of prenatal visits over expected visits		In the duration of pregnancy, an expected average of 9 months	No
Secondary	Uptake of government-subsidized programs	This outcome is measured by the following metrics: Duration of folic acid; Uptake of infant vaccinations	In the duration of pregnancy, an expected average of 9 months, and 1 month after birth	No
Secondary	C-section rate		child birth	No
Secondary	Maternal health	Maternal health is measured by change of perception in general health and postpartum depression.	Child birth and 1 year after birth	No
Secondary	Near-miss	The near-miss focuses on measuring severe maternal morbidity.	In the duration of pregnancy, an expected average of 9 months, and childbirth	No
Secondary	Psychological outcomes	Attitudes, personal norms, self-efficacy, social desirability, intentions, plans, susceptibility, expectations, and severity	In the duration of pregnancy, an expected average of 9 months	No