A Randomised Controlled Trial to Compare Antenatal Preparation and Postnatal Counseling

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

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2006-03-31

Brief Summary

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This is a randomised controlled trial to compare antenatal preparation and postnatal counseling strategies for improving breastfeeding rates.

The objectives are:

1. to study the effect of a standard two-encounter postnatal lactation counseling protocol on the initiation and maintenance of exclusive breastfeediing in mothers
2. to compare the effect of a standard two-encounter postnatal lactation counseling protocol with a single-encounter antenatal breastfeeding education protocol on the initiation and maintenance of exclusive breastfeeding in mothers.

Detailed Description

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All pregnant mothers who wish to breastfeed after 34 weeks of gestation, and who do not have a high risk pregnancy as determined by investigator or have a multiple pregnancy in current pregnancy and have given their written informed consent will be randomised into three groups. Group 1 will receive standard hospital care. Group 2 will receive 1 session of antenatal counseling and Group 3 will receive 2 sessions of postanatal lactation counseling. All will receive postnatal follow up phone calls using questions from Case Report Forms at 2 weeks, 8 weeks, 3 months, 6 months and 12 months. The mothers who are not contactable for 3 consecutive months will be withdrawn from the study.

Conditions

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Breastfeeding

Keywords

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Initiation, Maintenance, Breastfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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Lactation counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Pregnant woman who wants to breastfeed her child after 34 weeks of gestation and written informed consent given

Exclusion Criteria

Pregnant women with high risk pregnancy as determined by the investigator.

\-

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Mary Rauff, MBBS, FRCOG

Role: PRINCIPAL_INVESTIGATOR

National University of Singapore /National University Hospital

Locations

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National University Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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Morrow AL, Guerrero ML, Shults J, Calva JJ, Lutter C, Bravo J, Ruiz-Palacios G, Morrow RC, Butterfoss FD. Efficacy of home-based peer counselling to promote exclusive breastfeeding: a randomised controlled trial. Lancet. 1999 Apr 10;353(9160):1226-31. doi: 10.1016/S0140-6736(98)08037-4.

Reference Type BACKGROUND

PMID: 10217083 (View on PubMed)

Haider R, Ashworth A, Kabir I, Huttly SR. Effect of community-based peer counsellors on exclusive breastfeeding practices in Dhaka, Bangladesh: a randomised controlled trial [see commments]. Lancet. 2000 Nov 11;356(9242):1643-7. doi: 10.1016/s0140-6736(00)03159-7.

Reference Type RESULT

PMID: 11089824 (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 DERIVED

PMID: 17670909 (View on PubMed)

Other Identifiers

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NHG RPR 03002

Identifier Type: -

Identifier Source: secondary_id

NUS IRB 03003