Clinical trial NCT02037087: The Impact of Prenatal Short Messages (SMS) on Maternal and Newborn Health
Official title: The Impact of Prenatal Short Messages on Maternal and Newborn Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Short Message Service
Text Messaging
Keywords: Short Message Service
newborn health
maternal behavior
good household pregnancy practice
care seeking
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Xi'an Jiaotong University
First posted: 2014-01-15
Enrollment: 4467
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief 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.

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?

Eligibility criteria: 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.

Primary outcomes:
measure: Newborn health
timeFrame: the first month after birth
Secondary outcomes:
measure: Neonatal Adverse Outcome Indicator (NAOI)
timeFrame: the first month after birth
measure: Actual number of prenatal visits over expected visits
timeFrame: In the duration of pregnancy, an expected average of 9 months
measure: Uptake of government-subsidized programs
timeFrame: In the duration of pregnancy, an expected average of 9 months, and 1 month after birth
measure: C-section rate
timeFrame: child birth
measure: Maternal health
timeFrame: Child birth and 1 year after birth
measure: Near-miss
timeFrame: In the duration of pregnancy, an expected average of 9 months, and childbirth
measure: Psychological outcomes
timeFrame: In the duration of pregnancy, an expected average of 9 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Yanfang Su, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Xi'an Jiaotong University
name: Zhongliang Zhou, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Changzheng Yuan, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Jesse Heitner, MPP
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth College
name: Benjamin Campbell, BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.