Effect of Prenatal Counseling on Breastfeeding Rates in Twins

Breastfeeding Clinical Trial

Official title:

Effect of Prenatal Counseling on Breastfeeding Rates in Twins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738957
• Other study ID #: 1131/09
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: July 2014

Study information

• Verified date: April 2019
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: July 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View Citation

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. Epub 2007 Aug 1. — View Citation

Wong KL, Fong DY, Lee IL, Chu S, Tarrant M. Antenatal education to increase exclusive breastfeeding: a randomized controlled trial. Obstet Gynecol. 2014 Nov;124(5):961-8. doi: 10.1097/AOG.0000000000000481. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Twin infant´s breastfeeding rates	Comparison of the rates of twin infant breastfeeding rates between the PCG and CG until 180 days of infants' age.For this analysis, the data of patients who were still breastfeeding at 180 days of infants' age will be censored at the time of the last obtained information.	5 years