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临床试验/NCT02738957
NCT02738957已完成不适用

Effect of Prenatal Counseling on Breastfeeding Rates in Twins

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2009年9月最近更新:
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
116
试验地点
2
主要终点
Mother´s total and exclusive breastfeeding rates

研究概览

简要总结

Few studies have investigated breastfeeding in twins, and none have addressed the effect of antenatal counseling on breastfeeding twins.The purpose of this study is to investigate the effect of antenatal breastfeeding counseling on the breastfeeding rates in twin pregnancies.

详细描述

In singleton pregnancies, three randomized studies have recently examined the influence of antenatal breastfeeding education on the breastfeeding rates (Su et al. 2007; Mattar et al. 2007; Wong et al. 2014). Two of these studies did not find differences in the total breastfeeding rates between the groups that received and did not receive antenatal breastfeeding education at the infants' age of 6 months old (Su et al. 2007; Wong et al. 2014). However, Su et al. found higher exclusive breastfeeding rates for 6-months-old infants in the group that received antenatal counseling. In contrast, Mattar et al. 2007 found significantly difference in breastfeeding rates with individual counseling compared to non-counseling or only breastfeeding educational material with no counseling.

Few studies have investigated breastfeeding in twins specifically, and even fewer have focused on the duration of breastfeeding of twin infants. Furthermore, in our literature search, we did not find studies of breastfeeding of twins investigating the effect of antenatal education on breastfeeding twins. Our hypothesis is that mothers of twins receiving specific antenatal counseling on breastfeeding should have a higher rate of breastfeeding than mothers who do not receive antenatal breastfeeding counseling. Therefore, the purpose of this study was to investigate the effect of specific antenatal breastfeeding counseling on the breastfeeding rates in twin pregnancies.

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

性别
Female
接受健康志愿者

入选标准

  • twin pregnancies with both fetuses alive between 18 and 34 weeks of gestational age and followed at our twin clinic; absence of absolute contraindications for breastfeeding, such as positive serology for HIV, HTLV; absence of use of lactation inhibitors to treat prolactinoma, such as cabergoline and bromocriptine; and absence of major malformation of one or both twins that could preclude breastfeeding, including gastrointestinal defects, cleft lip and cleft palate, or malformations that would require neonatal surgery with prolonged hospital stay.

排除标准

  • fetal or postnatal death of one or both twins; delivery before 32 weeks; major malformation diagnosed postnatal; and lost to follow up or no breastfeeding information.

研究组 & 干预措施

Prenatal Counseling Group

Other

Patients in the PCG will receive specific counseling on breastfeeding consisting of three different counseling sessions during prenatal visits given by one two midwives involved in the study. The information will include: breastfeeding importance; how to prepare the nipples and breast for breastfeeding; the main complications and difficulties during the breastfeeding process and how to identify and overcome them; breastfeeding techniques and alternative positions for the simultaneous breastfeeding of twins, for example, "double cradle", "cradle-football" or "double-football", using illustrations and hands-on demonstration with doll models. During the counseling sessions patients will have the opportunity to discuss questions on breastfeeding.

干预措施: Prenatal Counseling Group (Behavioral)

Control Group

No Intervention

No breastfeeding counseling during the antenatal period will be provided. The Control Group will receive non-specific counseling with standard orientation regarding breastfeeding after delivery and during their postpartum hospitalization period. This standard orientation will be provided by one of the midwives of the hospital during a single counseling session with brief guidance covering the following topics: starting breastfeeding, hygiene, infants' conditions, colostrum/breast milk, infants' positions, duration of breastfeeding, frequency of feeds, mammary milking, and stopping breastfeeding.

结局指标

主要结局

Mother´s total and exclusive breastfeeding rates

时间窗: 5 years

Comparison of mothers' total and exclusive breastfeeding rates between the Prenatal Counseling Group (PCG) and Control Group (CG) in the three evaluated periods (30-40-days-old infants, 90-days-old infants and 180-days-old infants.

次要结局

  • Twin infant´s breastfeeding rates(5 years)

研究者

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

Maria de Lourdes Brizot

Dr

University of Sao Paulo

研究点 (2)

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