Condition category
Pregnancy and Childbirth
Date applied
01/09/2011
Date assigned
20/09/2011
Last edited
31/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Maternal mortality ratio (MMR) is the number of women who die during pregnancy and childbirth, per 100,000 live births. The MMR in Laos is one of the highest in the South East Asia region. Even though it has made substantial progress in the past 20 years, it is unlikely to achieve the target for the fifth Millennium Development Goal because antenatal care (ANC) utilization is quite low. Our previous study among rural villages in two provinces has shown that the women would be willing to attend the ANC services if they thought it was useful, and we have also found that quality of ANC services at health centres in rural Laos was restricted by lack of basic examination equipment and non-standardized ANC performance of healthcare providers. The aim of this study was to promote awareness among pregnant women about the usefulness of utilizing ANC services, such as consulting the healthcare providers in the first trimester of pregnancy or as soon as they believed they were pregnant, and attending ANC at least four times during a normal pregnancy.

Who can participate?
Pregnant women with gestational age more than 32 weeks and women who gave birth 6-12 months ago will be interviewed before and after the intervention.

What does the study involve?
The intervention has three components:
1. Community participation to promote ANC use: all people in the selected villages will be invited to meetings with the aim to raise awareness and promote utilization of ANC at the health centre level.
2. Provision of basic ANC equipment to intervention health centres.
3. Refresher courses on providing ANC services for healthcare providers at the health centres.

What are the possible benefits and risks of participating?
All participants would know where to seek for help when the pregnant women in their families have problems. The pregnant women are expected to utilise the ANC services to a higher extent for routine controls and for assessment and treatment of any pregnancy-related problems, which would result in healthy mothers and babies. There are no known risks to participants.

Where is the study run from?
The study took place in two provinces in Laos.

When is the study starting and how long is it expected to run for?
The pre-intervention survey took place in June 2008, and the intervention started in June 2010. The study ended 9 months from the start of the intervention.

Who is funding the study?
The Swedish International Development Cooperation Agency (Sida) and the Swedish Institute (SI).

Who is the main contact?
Associate professor Rolf Wahlström
Rolf.Wahlstrom@ki.se

Trial website

Contact information

Type

Scientific

Primary contact

Prof Rolf Wahlström

ORCID ID

Contact details

Karolinska Institutet
Division of Global Health (IHCAR)
Department of Public Health Sciences
Karolinska Institutet
Nobels väg 9
Stockholm
SE-171 77
Sweden
+46 (0)8 524 833 55
Rolf.Wahlstrom@ki.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UTRN: U1111-1123-9693

Study information

Scientific title

Improving antenatal care utilization through a low cost community intervention which includes community participation combined with the provision of basic ANC equipment to health centers and a refresher course for healthcare providers: a pragmatic randomized trial in two provinces in rural Laos People's Democratic Republic

Acronym

Study hypothesis

1. The overall ANC use should increase by 15% in the intervention arm compared to the control arm
2. Similar increases would be seen in the proportion of pregnant women visiting ANC at health centres four times or more

Ethics approval

National Ethics Committee for Health Research, Ministry of Health, Vientiane, Laos People's Democratic Republic, 30/04/2008, ref: 174/NECHR

Study design

Randomized non-blinded parallel-group controlled two-arm trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format. Participants were informed individually through verbal information before consent to take part in the interview.

Condition

Promotion of maternal and neonatal health

Intervention

1. Community participation to promote ANC use:
1.1. Sequential village meetings organized by important village representatives, such as the head of the village, the head of the Lao Women’s Union, and the village health volunteers
1.2. Target for the community participation where all people in the villages such as: men and women with different characteristics, such as married, unmarried, young and old.
1.3. Meetings to focus on the usefulness of antenatal care and the promotion of ANC utilisation at nearest health centre
2. Provision of basic ANC equipments to intervention health centres: each health centre in the intervention site was supplied with:
2.1. Sphygmomanometer
2.2. Stethoscope
2.3. Fetoscope
2.4. Urine test kits
2.5. Tape measure
2.6. Weighing scale
2.7. Cloth to cover the abdomen
2.8. ANC manual including a procedure checklist
2.9. Poster showing the usefulness of attending ANC and pregnancy record booklets for women
3. Refresher courses for healthcare providers at the health centres:
3.1. Review the importance of ANC provision
3.2. Focused ANC
3.3. Basic prevention and simple treatment for certain pregnancy complications (including the provision of iron tablets, tetanus vaccine, anti-parasite treatment and human immunodeficiency virus [HIV] information)
3.4. How to record the status at each visit
3.5. Using the ANC record booklet for pregnant women
3.6. Explanation of the ANC posters to carers

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Difference in overall ANC use as reported by the interviewed women and checked with the ANC record booklet

Secondary outcome measures

1. Difference in the proportions of women making at least the recommended four ANC visits, as reported by the women and checked with the ANC record booklet
2. Difference in the proportion of women making their visits at health centres, as reported by the women and checked with the ANC record booklet

Overall trial start date

01/06/2008

Overall trial end date

31/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Two provinces were selected and in each two districts were selected based on information from provincial health directors according to the study group’s criteria:
1. Geographically separate and with different economic standards
2. Ten villages were then randomly selected from each district: five with health centers and five without health centers but within their respective catchment area
3. The respondents are the women aged 15-49 years who were currently pregnant at the time of the pre-intervention and post-intervention interviews, respectively, with a reported gestational length of 32 weeks or more, or who had recently given birth (during the last year for the pre-intervention survey, and during the last six months for the post-intervention survey)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

181 women for each arm before and another 181 women in each arm after the intervention

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/06/2008

Recruitment end date

31/03/2011

Locations

Countries of recruitment

Laos

Trial participating centre

Karolinska Institutet
Stockholm
SE-171 77
Sweden

Sponsor information

Organisation

Swedish Agency for International Development Cooperation (Sida) / Department for Research Cooperation (SAREC) (Sweden)

Sponsor details

Vallhallavägen 199
Stockholm
10525
Sweden
+46 (0)8 698 50 00
sida@sida.se

Sponsor type

Government

Website

http://www.sida.se

Funders

Funder type

Government

Funder name

Swedish International Development Cooperation Agency (SIDA) (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swedish Institute (SI) (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ministry of Health of Laos People's Democratic Republic (Laos)

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