Condition category
Pregnancy and Childbirth
Date applied
10/05/2010
Date assigned
27/05/2010
Last edited
27/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Phnom Sukchan

ORCID ID

Contact details

Epidemiology Unit
Faculty of Medicine
Prince of Songkla University
Hat Yai
Songkhla
90112
Thailand

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EC 50/354-012

Study information

Scientific title

The effectiveness of nutritional and hand-hygiene educational programs on maternal anaemia and foetal birth weight in southern Thailand: a randomised controlled trial

Acronym

Study hypothesis

1. Nutritional and/or hand-hygiene programs can reduce the anaemia in pregnant women and improve foetal birth weight at delivery in soil-transmitted helminth (STH) endemic area.
2. Hand-hygiene program has synergistic effect to nutritional program to reduce anaemia in pregnant women and improve foetal birth weight in soil-transmitted helminth (STH) endemic area.

Ethics approval

Ethics approval was obtained from the Ethics Committee of Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand (reference no. EC 50/354-012), Ethic Committee of Ministry of Public Health (reference no. 9/2008)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

STH infestation, maternal anaemia, foetal birth weight

Intervention

1. Control: without any intervention
This group will not expose to any interventions and will receive normal routine standard of ANC.
2. Intervention 1: nutritional program
The 15 minutes flipchart on nutritional knowledge and practice consisted of four topics:
2.1. Importance of nutrition for mother and their foetus
2.2. Affect of malnutrition and further health problems
2.3. Kinds of food and adequate quantity for mother
2.4. Appropriate methods to choose and prepare food for cooking.
2. Intervention 2: hand hygiene program
The 15 minutes flipchart on hand-hygiene knowledge and practice consisted of four topics:
3.1. Epidemiology of STH and the effects on mother and baby
3.2. Important route of transmission
3.3. Important of hand hygiene for personal health and STH transmission
3.4. Correct methods of hand washing
4. Intervention 3: nutritional plus with hand hygiene program
The 30 minutes flipchart on nutritional and hand-hygiene knowledge

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Maternal anaemia, defined as haemoglobin <11g/dL (WHO criteria), measured at recruitment (12-20 weeks) and 32 weeks of gestation.
2. Foetal birth weight

Secondary outcome measures

STH infestation:
Binary outcome is infested or not infested. If infested then the intensity and type of helminths is measured at recruitment( 12-20weeks) and 3 month after recruitment.

Overall trial start date

01/01/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

All pregnant women with a gestational age of twelve to twenty weeks, who had lived in Narathiwat province for at least one year and were attending the antenatal clinic in four of the study hospitals at first visit.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

648

Participant exclusion criteria

1. High-risk pregnancies such as severe anaemia of less than seven gm/dl
2. Heart disease
3. HIV positive/AIDS
4. Any mental problems

Recruitment start date

01/01/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Thailand

Trial participating centre

Epidemiology Unit
Songkhla
90112
Thailand

Sponsor information

Organisation

Prince of Songkla University (Thailand)

Sponsor details

Epidemiology Unit
Faculty of Medicine
Hat Yai
Songkhla
90112
Thailand

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Institute of Research and Development for Health of Southern Thailand (Thailand)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes