NCT01894126

Brief Summary

With the increased prevalence of cellular phones, mobile technology provides an important tool to reach underserved populations in low to middle income countries. mHealth interventions offer promise to improve maternal child health throughout the reproductive health continuum if they contribute to increasing skilled birth attendance, family planning and exclusive breastfeeding. We propose a randomized clinical trial to determine effect of using mobile phones to deliver SMS (one-way) versus an interactive SMS dialogue (two-way) on uptake of reproductive and neonatal health services and maternal and infant outcomes

Trial Health

80
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ 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

July 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

July 2, 2013

Last Update Submit

November 7, 2016

Conditions

Outcome Measures

Primary Outcomes (3)

  • Contraceptive uptake

    10 weeks postpartum; 24 weeks postpartum

  • Facility Delivery

    Postpartum

  • Exclusive Breastfeeding

    24 weeks postpartum

Secondary Outcomes (4)

  • ANC attendance

    Postpartum

  • Infant Immunizations

    Six months postpartum

  • Maternal mortality

    6 months postpartum

  • Infant mortality

    Six months postpartum

Study Arms (3)

Two-way SMS dialogue

EXPERIMENTAL

Women will receive SMS messages with prompts to reply. They will have the ability to text back to the system and both respond to and initiate SMS dialogue

Behavioral: Two-way SMS Dialogue

One-way SMS Messaging

EXPERIMENTAL

Women will receive scheduled one-way SMS messages

Behavioral: One-way SMS Messaging

Control

NO INTERVENTION

Interventions

Two-way SMS dialogue
One-way SMS Messaging

Eligibility Criteria

Age14 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant
  • Access to a mobile phone
  • Able to read SMS messages
  • Willing to receive SMS messages

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mathare North Health Centre

Nairobi, Kenya

Location

Related Publications (1)

  • Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 2, 2013

First Posted

July 9, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2015

Last Updated

November 9, 2016

Record last verified: 2016-11

Locations