- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03810716
Promotion of Family Planning Methods Through an Interactive Platform Offered in Growth and Development Control Services
Family planning and the use of contraceptive methods are of the main strategies to reduce maternal and perinatal morbidity and mortality, because they can prevent unplanned pregnancies, teenage pregnancies and abortions in dangerous conditions. It is also a tool that contributes to development as it improves children's health, improves access to early childhood education, empowers women and contributes to reducing poverty as it improves economic conditions.
Currently the use of modern contraceptive methods has increased worldwide, in Latin America and the Caribbean the use of modern contraceptive methods has remained at 66.07% from 2008 to 2015. However, the number of women who do not want to get pregnant and that do not use a contraceptive method is still high - 214 million women of childbearing age in developed countries.
In our country according to the ENDES 2016 survey, the number of women who used a contraceptive method decreased by 0.7 percent compared to 2012, of which 54.3 percent used some modern contraceptive method and 21.9 percent some method traditional.
The unmet demand for family planning in 2016 was 6.0%, affecting mainly women from the lowest poverty quintile (7.4%) and those living in rural areas (6.8%).
Of the women who were surveyed and did not use a contraceptive method, 80.6% did not talk about family planning either at home or in a health facility in the last 12 months. Only 16.3% of non-users were women who attended a health facility and received information on family planning.
Through this study the investigators propose the design and evaluation of an interactive platform to promote modern contraceptive methods.
Study Overview
Detailed Description
Sample Size: Sample size of 176 participants (interventional group=88, control group=88), it is possible to detect minimum differences of 5% to 20%.
Statistical analysis plan: The data collected will be entered into a database in Microsoft Excel, to be analyzed by the Epi Info statistical program. The qualitative variables will be analyzed by frequencies and percentages, the quantitative variables by relative risk.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Los Olivos
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Lima, Los Olivos, Peru, L39
- Cueto Fernandini
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Lima, Los Olivos, Peru, L39
- Los Olivos
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Mothers of children who attend the service of growth and development who are of legal age
- Women who do not currently use some modern contraceptive method
- Women whose partners have not received voluntary surgical contraception
Exclusion Criteria:
- Teen mothers
- Illiterate women
- Women who currently do not have a partner
- Women who are currently gestating
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interactive Platform
Tha participants in this group will see the interactive platform and answer a survey before and after the intervention.
Their clinical health records will be checked one month ago.
|
The participants will see the interactive platform.
|
|
No Intervention: Control
The participants in this group will answer the survey.
Their clinical health records will be checked one month ago.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of mothers who attend the family planning service
Time Frame: one month
|
Percentage of women who assist to family planning service after the intervention
|
one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of mothers who initiate a contraceptive method
Time Frame: one month after the intervention
|
Percentage of mothers who initiate a contraceptive method after the intervention
|
one month after the intervention
|
|
Satisfaction of the users about the interactive platform
Time Frame: immediately after the intervention
|
The participants will answer a survey to rate usability after the intervention.
This survey is a likert survey.
|
immediately after the intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Suzzane S Minaya Romero, BSc
Publications and helpful links
General Publications
- Sheoran B, Braun RA, Gaarde JP, Levine DK. The hookup: collaborative evaluation of a youth sexual health program using text messaging technology. JMIR Mhealth Uhealth. 2014 Nov 3;2(4):e51. doi: 10.2196/mhealth.3583.
- Mishra N, Panda M, Pyne S, Srinivas N, Pati S, Pati S. Barriers and enablers to adoption of intrauterine device as a contraceptive method: A multi-stakeholder perspective. J Family Med Prim Care. 2017 Jul-Sep;6(3):616-621. doi: 10.4103/2249-4863.222028.
- Ngum Chi Watts MC, Liamputtong P, Carolan M. Contraception knowledge and attitudes: truths and myths among African Australian teenage mothers in Greater Melbourne, Australia. J Clin Nurs. 2014 Aug;23(15-16):2131-41. doi: 10.1111/jocn.12335. Epub 2013 Sep 13.
- Ewerling F, Victora CG, Raj A, Coll CVN, Hellwig F, Barros AJD. Demand for family planning satisfied with modern methods among sexually active women in low- and middle-income countries: who is lagging behind? Reprod Health. 2018 Mar 6;15(1):42. doi: 10.1186/s12978-018-0483-x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SIDISI: 102347
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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