Effect of Prenatal Counseling on Breastfeeding Rates in Twins

NCT02738957 | Completed

• 1 other identifier: 1131/09
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breastfeeding

Outcome Measures

Primary Outcomes (1)

• Mother´s total and exclusive breastfeeding rates

  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.

  5 years

Secondary Outcomes (1)

• Twin infant´s breastfeeding rates

  5 years

Study Arms (2)

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.

Behavioral: Prenatal Counseling Group

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.

Interventions

Prenatal Counseling Group 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.

Prenatal Counseling Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clinicas

São Paulo, São Paulo, 05403000, Brazil

Location

Related Publications (4)

• 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.

  PMID: 17197590 BACKGROUND

• 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.

  PMID: 17670909 BACKGROUND

• 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.

  PMID: 25437725 BACKGROUND

• 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.

  PMID: 28063805 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• MARIA DE LOURDES BRIZOT, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 14, 2016
• Study Start: September 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: July 1, 2014
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)