Effect of Prenatal Counseling on Breastfeeding Rates in Twins

NCT ID: NCT02738957

Last Updated: 2019-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breastfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Prenatal Counseling Group

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.

Group Type OTHER

Prenatal Counseling Group

Intervention Type BEHAVIORAL

Specific counseling on breastfeeding consisting of three different counseling sessions during prenatal visits given by one of the two midwives involved in the study. The information provided include the following: 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.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prenatal Counseling Group

Specific counseling on breastfeeding consisting of three different counseling sessions during prenatal visits given by one of the two midwives involved in the study. The information provided include the following: 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Maria de Lourdes Brizot

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MARIA DE LOURDES BRIZOT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Hospital das Clinicas

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Mattar CN, Chong YS, Chan YS, Chew A, Tan P, Chan YH, Rauff MH. Simple antenatal preparation to improve breastfeeding practice: a randomized controlled trial. Obstet Gynecol. 2007 Jan;109(1):73-80. doi: 10.1097/01.AOG.0000249613.15466.26.

Reference Type BACKGROUND
PMID: 17197590 (View on PubMed)

Su LL, Chong YS, Chan YH, Chan YS, Fok D, Tun KT, Ng FS, Rauff M. Antenatal education and postnatal support strategies for improving rates of exclusive breast feeding: randomised controlled trial. BMJ. 2007 Sep 22;335(7620):596. doi: 10.1136/bmj.39279.656343.55. Epub 2007 Aug 1.

Reference Type BACKGROUND
PMID: 17670909 (View on PubMed)

Wong KL, Tak Fong DY, Yin Lee IL, Chu S, Tarrant M. Antenatal education to increase exclusive breastfeeding: a randomized controlled trial. Obstet Gynecol. 2014 Nov;124(5):961-968. doi: 10.1097/AOG.0000000000000481.

Reference Type BACKGROUND
PMID: 25437725 (View on PubMed)

Mikami FC, de Lourdes Brizot M, Tase TH, Saccuman E, Vieira Francisco RP, Zugaib M. Effect of Prenatal Counseling on Breastfeeding Rates in Mothers of Twins. J Obstet Gynecol Neonatal Nurs. 2017 Mar-Apr;46(2):229-237. doi: 10.1016/j.jogn.2016.10.005. Epub 2017 Jan 5.

Reference Type DERIVED
PMID: 28063805 (View on PubMed)

Other Identifiers

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1131/09

Identifier Type: -

Identifier Source: org_study_id

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