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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03810716
Other study ID # SIDISI: 102347
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 29, 2018
Est. completion date December 27, 2018

Study information

Verified date January 2019
Source Universidad Peruana Cayetano Heredia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 176
Est. completion date December 27, 2018
Est. primary completion date December 27, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Interactive Platform
The participants will see the interactive platform.

Locations

Country Name City State
Peru Cueto Fernandini Lima Los Olivos
Peru Los Olivos Lima Los Olivos

Sponsors (1)

Lead Sponsor Collaborator
Universidad Peruana Cayetano Heredia

Country where clinical trial is conducted

Peru, 

References & Publications (4)

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: 10.11 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of mothers who attend the family planning service Percentage of women who assist to family planning service after the intervention one month
Secondary Percentage of mothers who initiate a contraceptive method Percentage of mothers who initiate a contraceptive method after the intervention one month after the intervention
Secondary Satisfaction of the users about the interactive platform The participants will answer a survey to rate usability after the intervention. This survey is a likert survey. immediately after the intervention
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