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Perinatal mHealth Intervention in Guatemala

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ClinicalTrials.gov Identifier: NCT02348840
Recruitment Status : Completed
First Posted : January 28, 2015
Results First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Gari Clifford, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Conditions Pregnancy
Prenatal Care
Intervention Device: mHealth
Enrollment 843
Recruitment Details Traditional birth attendants (TBAs) were recruited from the municipality of Tecpán Chimaltenango, in rural Guatemala. Enrollment of the TBAs began in January 2015 and eligible pregnant participants were recruited from April 2016 to March 2017. All study follow up ended by February 28, 2018.
Pre-assignment Details There were 64 TBAs in the study area meeting eligibility criteria who were invited to attend an informational session. Of the eligible TBAs, 49 attended the session and 44 of those individuals agreed to participate in the study.
Arm/Group Title TBA - Early Access Arm TBA - Later Access Arm Pregnant Women - Early Access Arm Pregnant Women - Later Access Arm
Hide Arm/Group Description Traditional birth attendants (TBAs) receiving access to mHealth technology immediately and using it for 12 months Traditional birth attendants (TBAs) without access to mHealth technology for the first half of the study who then used mHealth for the remaining time of the 12 month study period Pregnant women under the care of traditional birth attendants in the early access arm Pregnant women under the care of traditional birth attendants in the later access arm
Period Title: Overall Study
Started 23 21 425 374
Completed 21 20 425 374
Not Completed 2 1 0 0
Reason Not Completed
Withdrawal by Subject             2             1             0             0
Arm/Group Title TBA - Early Access Arm TBA - Later Access Arm Pregnant Women - Early Access Arm Pregnant Women - Later Access Arm Total
Hide Arm/Group Description Traditional birth attendants (TBAs) receiving access to mHealth technology immediately and using it for 12 months Traditional birth attendants (TBAs) without access to mHealth technology for the first half of the study who then used mHealth for the remaining time of the 12 month study period Pregnant women under the care of traditional birth attendants in the early access arm, who completed their pregnancy during the study period Pregnant women under the care of traditional birth attendants in the later access arm, who completed their pregnancy during the study period Total of all reporting groups
Overall Number of Baseline Participants 23 21 335 327 706
Hide Baseline Analysis Population Description
The baseline analysis population includes all TBAs and pregnant women for whom demographic data was collected.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 335 participants 327 participants 706 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
 100.0%
21
 100.0%
335
 100.0%
327
 100.0%
706
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 335 participants 327 participants 706 participants
Female
23
 100.0%
21
 100.0%
335
 100.0%
327
 100.0%
706
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Indigenous Mayan Number Analyzed 23 participants 21 participants 335 participants 327 participants 706 participants
23
 100.0%
21
 100.0%
335
 100.0%
327
 100.0%
706
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Guatemala Number Analyzed 23 participants 21 participants 335 participants 327 participants 706 participants
23
 100.0%
21
 100.0%
335
 100.0%
327
 100.0%
706
 100.0%
1.Primary Outcome
Title Referral Rates to Local Hospitals
Hide Description TBAs refer pregnant women to local hospitals for further evaluation or treatment when a pregnancy complications are detected. The median adjusted monthly emergency referral rates (referrals/births) per 100 births for each time period are presented here.
Time Frame Month 7, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All TBAs are included in this analysis.
Arm/Group Title TBA - Early Access Arm TBA - Later Access Arm
Hide Arm/Group Description:
Traditional birth attendants receiving access to mHealth technology immediately and using it for 12 months
Traditional birth attendants without access to mHealth technology for the first six months, and then using the technology for the remaining six months
Overall Number of Participants Analyzed 23 21
Median (Inter-Quartile Range)
Unit of Measure: Referrals per 100 births
Month 7
33
(22 to 58)
20
(0 to 30)
Month 12
31
(10 to 42)
34
(5 to 50)
2.Primary Outcome
Title Number of Neonatal Deaths
Hide Description The number of neonatal deaths during the entire study period are presented. Baseline complication rates were unknown for this study population and the study was not powered to detect a difference in the rate of any complication (including neonatal deaths), thus only the total deaths during the entire 12 month period are included.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All pregnant participants are included in this analysis.
Arm/Group Title Pregnant Women - Early Access Arm Pregnant Women - Later Access Arm
Hide Arm/Group Description:
Pregnant women under the care of traditional birth attendants in the early access arm, who completed their pregnancy during the study period
Pregnant women under the care of traditional birth attendants in the later access arm, who completed their pregnancy during the study period
Overall Number of Participants Analyzed 425 374
Measure Type: Number
Unit of Measure: deaths
7 3
3.Secondary Outcome
Title Successful Referrals
Hide Description Referrals to hospitals for further evaluation of possible pregnancy complications were considered to be successful if the pregnant participant went to the hospital after being referred by her TBA. Non-successful referrals were due to the pregnant participant's refusal to go to the hospital (due to lack of permission from a family member, fear, or not recognizing the complication as an emergency) or due to logistical difficulties.
Time Frame Month 7, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
There were a different number of referrals made during each study period; the overall number analyzed represents the maximum count of referrals in a study period for that study arm.
Arm/Group Title TBA - Early Access Arm TBA - Later Access Arm
Hide Arm/Group Description:
Traditional birth attendants receiving access to mHealth technology immediately and using it for 12 months
Traditional birth attendants without access to mHealth technology for the first six months, and then using the technology for the remaining six months
Overall Number of Participants Analyzed 23 21
Overall Number of Units Analyzed
Type of Units Analyzed: Referrals made during the study period
76 51
Measure Type: Number
Unit of Measure: Referrals to hospital
First study period Number Analyzed 76 Referrals made during the study period 47 Referrals made during the study period
69 44
Second study period Number Analyzed 49 Referrals made during the study period 51 Referrals made during the study period
48 47
Time Frame Protocol-related adverse events for pregnant participants were collected during the 12 month intervention period.
Adverse Event Reporting Description Only protocol-related serious and non-serious adverse events for pregnant participants were collected. Adverse events were not collected from the traditional birth attendants as adverse events related to the study intervention were not expected to impact these participants.
 
Arm/Group Title TBA - Early Access Arm TBA - Later Access Arm Pregnant Women - Early Access Arm Pregnant Women - Later Access Arm
Hide Arm/Group Description Traditional birth attendants receiving access to mHealth technology immediately and using it for 12 months Traditional birth attendants without access to mHealth technology for the first six months, and then using the technology for the remaining six months Pregnant women under the care of traditional birth attendants in the early access arm, who completed their pregnancy during the study period Pregnant women under the care of traditional birth attendants in the later access arm, who completed their pregnancy during the study period
All-Cause Mortality
TBA - Early Access Arm TBA - Later Access Arm Pregnant Women - Early Access Arm Pregnant Women - Later Access Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   2/425 (0.47%)   1/374 (0.27%) 
Hide Serious Adverse Events
TBA - Early Access Arm TBA - Later Access Arm Pregnant Women - Early Access Arm Pregnant Women - Later Access Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/425 (0.00%)   0/374 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TBA - Early Access Arm TBA - Later Access Arm Pregnant Women - Early Access Arm Pregnant Women - Later Access Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/425 (0.00%)   0/374 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gari D. Clifford, DPhil
Organization: Emory University
Phone: 404-727-0229
EMail: gari.clifford@emory.edu
Layout table for additonal information
Responsible Party: Gari Clifford, Emory University
ClinicalTrials.gov Identifier: NCT02348840    
Other Study ID Numbers: IRB00076231
R21HD084114-02 ( U.S. NIH Grant/Contract )
First Submitted: January 23, 2015
First Posted: January 28, 2015
Results First Submitted: June 4, 2019
Results First Posted: August 9, 2019
Last Update Posted: August 9, 2019