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临床试验/NCT02989766
NCT02989766已完成不适用

Preparing Mothers for Feeding Their Newborns: A Self-Guided Program for Pregnant Women

St. Louis University0 个研究点目标入组 335 人开始时间: 2015年8月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
335
主要终点
improving duration of BF.

研究概览

简要总结

This intervention would be a series of self-help-style educational and motivational activity sheets for patients to complete independently. This will be a randomized clinical control trial.

Subjects will complete a pre delivery questionnaire and a postpartum questionnaire. Subjects in the intervention arm will complete 3 activity sheets prenatally during their wait time at the clinic. The first worksheet can be completed the day of recruitment after consent is signed.

Subjects will be contacted by phone at 3 and 6 months postpartum to assess long term duration of breast feeding.

详细描述

As the benefits of human milk become evident, the investigators are striving to improve the breastfeeding (BF) rate among new mothers. In April and May of 2014, 73 (71%) of well babies received human milk at discharge from our postpartum unit, with 40 (35%) and receiving human milk exclusively. In the neonatal intensive care unit, 83 (89%) received human milk during those months.

Many of the patients at the teaching institution share risk factors for failure to BF, including poverty, obesity, unplanned pregnancy and being African American. Efforts have had limited effect in improving initiation and duration among these patients.

Studies examining the efficacy of various modalities of antenatal education produced modest results in improving initiation and duration of BF. Several studies examined group BF education versus routine prenatal care without significant differences in initiation, exclusivity (the practice of using human milk exclusively and not supplementing with formula) or duration. Conversely, other study showed a difference in initiation with group education and showed a difference in exclusivity. Formalized education compared to routine clinical practice education did not result in a difference in exclusivity in several studies and neither did a program that included a video showed a difference in initiation with formal education.

A few studies compared peer counseling to routine prenatal care. One small study of 59 women found an increase in initiation rate, while a larger study of 2511 women did not find a difference in initiation or duration.

Other studies found no significant difference in initiation, duration or exclusivity with an educational program on practical BF skills nor a program on BF attitudes. A small study that paired BF education with material incentives increased exclusivity. Three studies comparing interventions by lactation consultants found no difference in initiation or duration, although one study showed improvement in exclusivity. Postpartum BF self-efficacy correlates with BF duration and two studies showed improvement in exclusivity with a BF class based on principles of self-efficacy. These studies based their intervention on Bandura's theory of self-efficacy, which proposes that an individual's expectation of personal efficacy will determine her initiation of coping behavior, effort expenditure and duration of persistence. This theory recognizes four components that contribute to an individual's sense of self- efficacy, and these include performance accomplishment, vicarious, or social, experience, verbal persuasion and psychological state. developed a validated scale at measuring prenatal maternal self-efficacy in breastfeeding.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
14 Years 至 55 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Patients < 32 weeks gestation.

排除标准

  • •Patient who have not had an ultrasound confirming viable intrauterine pregnancy.
  • •Patients beyond 32 weeks gestation will be excluded as some are unlikely to return for a sufficient number of prenatal visits to complete the intervention.
  • •Patients with medical contraindications to breastfeeding such as HIV or active substance abuse.
  • •Patients planning to take medications in the postpartum period that are incompatible with breastfeeding such as anti-metabolites.
  • •Patients giving birth to a nonviable infant.
  • •Patients without adequate reading and writing skills to complete the questionnaires and activity sheets.

研究组 & 干预措施

A - Intervention

Active Comparator

Education on Breast Feeding 3 activity sheets prenatally-study related. Complete a pre-questionnaire, a pre-delivery and a postpartum questionnaire

干预措施: Education on Breast Feeding (Behavioral)

B - Standard of Care

No Intervention

Complete a pre-questionnaire, a pre-delivery and a postpartum questionnaire

结局指标

主要结局

improving duration of BF.

时间窗: 16 Months

It was propose using a 3-part prenatal self-help guide to educate and prepare mothers for breastfeeding.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaye Shyken, MD

MD

St. Louis University

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