NCT02037087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,467

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

2.1 years

First QC Date

January 14, 2014

Last Update Submit

April 6, 2016

Conditions

Short Message ServiceText Messaging

Keywords

Short Message Servicenewborn healthmaternal behaviorgood household pregnancy practicecare seeking

Outcome Measures

Primary Outcomes (1)

  • Newborn health

    Newborn health is measured by appropriateness of weight for gestational age.

    the first month after birth

Secondary Outcomes (7)

  • Neonatal Adverse Outcome Indicator (NAOI)

    the first month after birth

  • Actual number of prenatal visits over expected visits

    In the duration of pregnancy, an expected average of 9 months

  • Uptake of government-subsidized programs

    In the duration of pregnancy, an expected average of 9 months, and 1 month after birth

  • C-section rate

    child birth

  • Maternal health

    Child birth and 1 year after birth

  • +2 more secondary outcomes

Study Arms (4)

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.

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.

Behavioral: Care seeking

Full bank of SMS

EXPERIMENTAL

This arm receives the SMS messages delivered to the GHPP, CS and control group.

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.

Interventions

Good household prenatal practiceBEHAVIORAL

Knowledge on nutrition, labor, non-medical pain management, breastfeeding and depression

Good household prenatal practice (GHPP)
Care seekingBEHAVIORAL

* Danger-sign recognition * Reminders for government projects

Care seeking (CS)
Full bank of SMSBEHAVIORAL

* Danger-sign recognition * Reminders for government projects * Knowledge on nutrition, labor, non-medical pain management, breastfeeding and depression

Full bank of SMS

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xi'an Jiaotong University

Xi'an, Shaanxi, 710049, China

Location

Related Publications (2)

  • 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.

    PMID: 33141099DERIVED

  • 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.

    PMID: 27515750DERIVED

Study Officials

  • Yanfang Su, MA

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

  • Zhongliang Zhou, PhD

    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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ScD

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 15, 2014

Study Start

September 1, 2013

Primary Completion

October 1, 2015

Study Completion

March 1, 2016

Last Updated

April 7, 2016

Record last verified: 2016-04

Locations

CN(1)