Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04655846 |
| Other study ID # |
2453 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 18, 2019 |
| Est. completion date |
June 18, 2021 |
Study information
| Verified date |
December 2020 |
| Source |
Universidad Industrial de Santander |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
About 40% of children under six months are breastfed. However, in adolescent mothers there
are greater barriers to making the decision to breastfeed. Counseling on breastfeeding could
be a helpful intervention in sustaining this practice. This is a single-blind randomized
controlled trial type study, with a control group that will receive routine care, and an
intervention group that will additionally receive "Counseling: breastfeeding" through a
maternity preparation course, both conducted by trained nurses. 59 pregnant women will be
included in each group that attend the prenatal control program, for a total of 118 users.
The level of knowledge about breastfeeding, the rate of cessation of breastfeeding and the
rate of cessation will be evaluated in three measurements during follow-up.
Description:
Introduction: The World Health Organization establishes that only 38% of children under six
months of age in the developing world are exclusively breastfed and only 39% of children
between 20 and 23 months they benefit from this practice. This problem is more evident in
adolescent mothers, in whom the social, family and cultural influence, their level of
knowledge, and the quality of health care services are decisive in the decision to give
breast milk to their babies or not. sons. In this sense, nursing must design and implement
educational intervention strategies for the promotion, protection and support of exclusive
breastfeeding in the first six months of life.
Objective: To determine the efficacy of an educational intervention in first pregnant
adolescents for the maintenance of exclusive breastfeeding in the first six months of life.
Methods: experimental study type randomized controlled clinical trial with first-pregnant
adolescents assigned to an intervention group and a control group. The sample will be made up
of a total of 118 first-pregnant women, 59 first-pregnant women in each study group.
The intervened group, in addition to receiving the usual prenatal care education, will
receive an educational intervention of counseling on breastfeeding. The control group, in
addition to the usual information on prenatal care, will receive an educational intervention
related to infant care activities. The educational intervention will take place in 4 weekly
sessions. Likewise, the intervention and control group will be given the final assessment of
knowledge once the fourth educational intervention is finished and at 6 months postpartum. In
addition, the maintenance of exclusive breastfeeding will be verified in the intervention and
control group through home visits at two, four and six months postpartum.
Randomization: It will be carried out by blocks in groups of equal size, randomized 1: 1. The
generation will be given by one of the researchers who will not perform the intervention, nor
the initial or final evaluations.
Expected results: it is expected to increase the level of knowledge and a lower rate of
abandonment of breastfeeding in the group of first pregnant adolescents operated on.
