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WomenNCT03810716

Promotion of Family Planning Methods Through an Interactive Platform Offered in Growth and Development Control Services

A study testing Interactive Platform in people with Women, run by Universidad Peruana Cayetano Heredia at 2 sites in Peru.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Women
What is being tested?
Interactive Platform
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
2 sitesPeru
Study dates
29 Oct 2018to 27 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Teen mothers
  • Illiterate women
  • Women who currently do not have a partner
  • Women who are currently gestating

Trial locations and contacts

2 sites in 1 country.

Peru2 sites

  • Cueto Fernandini

    Lima, Los Olivos, L39

  • Los Olivos

    Lima, Los Olivos, L39

Other trials in Peru

About this study

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.

Read more

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.

Read the 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.

Conditions
Women
Being tested
Interactive Platform
Keywords
interactive platform, family planning, contraception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interactive PlatformDevice

    The participants will see the interactive platform.

Study groups in NCT03810716
Study groupRoleWhat they receive
Interactive PlatformExperimentalTha 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.
Receives: Device: Interactive Platform
ControlNo interventionThe participants in this group will answer the survey. Their clinical health records will be checked one month ago.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of mothers who attend the family planning service

    Percentage of women who assist to family planning service after the intervention

    Measured: one month

Secondary outcomes (2)

  1. Percentage of mothers who initiate a contraceptive method

    Percentage of mothers who initiate a contraceptive method after the intervention

    Measured: one month after the intervention

  2. 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.

    Measured: immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2019
  2. Study start29 Oct 2018
  3. Primary completion27 Dec 2018
  4. Study completion27 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Quasi - experimental study design.
Masking
None (open label)
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03810716
Sponsor's protocol ID
SIDISI: 102347
Status last verified
Jan 2019
First submitted
8 Oct 2018
Last updated
22 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan description. No applicable.

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.

    PubMed 25367444

  • 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.

    PubMed 29417019

  • 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.

    PubMed 24028778

  • 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.

    PubMed 29510682

Questions about this trial

What is this clinical trial studying?

A study testing Interactive Platform in people with Women, run by Universidad Peruana Cayetano Heredia at 2 sites in Peru.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of mothers who attend the family planning service (time frame: one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03810716, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.

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