Trial Outcomes & Findings for Perinatal mHealth Intervention in Guatemala (NCT NCT02348840)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

843 participants

Primary outcome timeframe

Month 7, Month 12

Results posted on

2019-08-09

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	TBA - Early Access Arm Traditional birth attendants (TBAs) receiving access to mHealth technology immediately and using it for 12 months	TBA - Later Access Arm 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 - Early Access Arm Pregnant women under the care of traditional birth attendants in the early access arm	Pregnant Women - Later Access Arm Pregnant women under the care of traditional birth attendants in the later access arm
Overall Study STARTED	23	21	425	374
Overall Study COMPLETED	21	20	425	374
Overall Study NOT COMPLETED	2	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	TBA - Early Access Arm Traditional birth attendants (TBAs) receiving access to mHealth technology immediately and using it for 12 months	TBA - Later Access Arm 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 - Early Access Arm Pregnant women under the care of traditional birth attendants in the early access arm	Pregnant Women - Later Access Arm Pregnant women under the care of traditional birth attendants in the later access arm
Overall Study Withdrawal by Subject	2	1	0	0

Baseline Characteristics

Perinatal mHealth Intervention in Guatemala

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TBA - Early Access Arm n=23 Participants Traditional birth attendants (TBAs) receiving access to mHealth technology immediately and using it for 12 months	TBA - Later Access Arm n=21 Participants 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 - Early Access Arm n=335 Participants Pregnant women under the care of traditional birth attendants in the early access arm, who completed their pregnancy during the study period	Pregnant Women - Later Access Arm n=327 Participants Pregnant women under the care of traditional birth attendants in the later access arm, who completed their pregnancy during the study period	Total n=706 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	21 Participants n=7 Participants	335 Participants n=5 Participants	327 Participants n=4 Participants	706 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	21 Participants n=7 Participants	335 Participants n=5 Participants	327 Participants n=4 Participants	706 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Indigenous Mayan	23 Participants n=5 Participants	21 Participants n=7 Participants	335 Participants n=5 Participants	327 Participants n=4 Participants	706 Participants n=21 Participants
Region of Enrollment Guatemala	23 Participants n=5 Participants	21 Participants n=7 Participants	335 Participants n=5 Participants	327 Participants n=4 Participants	706 Participants n=21 Participants

PRIMARY outcome

Timeframe: Month 7, Month 12

Population: All TBAs are included in this analysis.

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.

Outcome measures

Outcome measures
Measure	TBA - Early Access Arm n=23 Participants Traditional birth attendants receiving access to mHealth technology immediately and using it for 12 months	TBA - Later Access Arm n=21 Participants Traditional birth attendants without access to mHealth technology for the first six months, and then using the technology for the remaining six months
Referral Rates to Local Hospitals Month 12	31 Referrals per 100 births Interval 10.0 to 42.0	34 Referrals per 100 births Interval 5.0 to 50.0
Referral Rates to Local Hospitals Month 7	33 Referrals per 100 births Interval 22.0 to 58.0	20 Referrals per 100 births Interval 0.0 to 30.0

PRIMARY outcome

Timeframe: Month 12

Population: All pregnant participants are included in this analysis.

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.

Outcome measures

Outcome measures
Measure	TBA - Early Access Arm n=425 Participants Traditional birth attendants receiving access to mHealth technology immediately and using it for 12 months	TBA - Later Access Arm n=374 Participants Traditional birth attendants without access to mHealth technology for the first six months, and then using the technology for the remaining six months
Number of Neonatal Deaths	7 deaths	3 deaths

SECONDARY outcome

Timeframe: Month 7, Month 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	TBA - Early Access Arm n=76 Referrals made during the study period Traditional birth attendants receiving access to mHealth technology immediately and using it for 12 months	TBA - Later Access Arm n=51 Referrals made during the study period Traditional birth attendants without access to mHealth technology for the first six months, and then using the technology for the remaining six months
Successful Referrals First study period	69 Referrals to hospital	44 Referrals to hospital
Successful Referrals Second study period	48 Referrals to hospital	47 Referrals to hospital

Adverse Events

TBA - Early Access Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TBA - Later Access Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pregnant Women - Early Access Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Pregnant Women - Later Access Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gari D. Clifford, DPhil

Emory University

Phone: 404-727-0229

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place