Condition category
Haematological Disorders
Date applied
25/04/2013
Date assigned
07/05/2013
Last edited
03/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The Four Pillars Approach (FPA) is a new approach to anaemia in pregnancy combining four strategies to improve antenatal and delivery care. The main objective is to measure the effect of the FPA on pregnant women with anaemia.

Who can participate?
A total of 360 pregnant women with anaemia will participate.

What does the study involve?
The Four Pillars Approach was implemented in treatment groups and the usual care was implemented in control groups. The results of those interventions (Four Pillars Approach and usual care) were compared. The Four Pillars Approach is: healthy life style, social support, adequate skills and knowledge of nurse midwives of anaemia in pregnancy, and nurse midwives' caring behaviour. The participants in treatment groups were involved in parenting class and will receive a booklet of anaemia in pregnancy.

What are the possible benefits and risks of participating?
The participants received a regular haemoglobin (Hb) measurement and free consultation. There are no risks.

Where is the study run from?
The study ran from Yogyakarta, Indonesia.

When is the study starting and how long is it expected to run for?
The study started in mid 2012 and ran for a period of six months. The study can be extended if needed.

Who is funding the study?
Funded by Indonesian Government

Who is the main contact?
Professor Dr. A. Lagro -Janssen, A.Lagro-Janssen@elg.umcn.nl
Widyawati, SKp., M.Kes., A.Widyawati@elg.umcn.nl

Trial website

Contact information

Type

Scientific

Primary contact

Ms Widyawati Widyawati

ORCID ID

Contact details

PSIK FK UGM
Gedung Ismangoen Lt. 2
Jl. Farmako
Sekip Utara
Yogyakarta
55281
Indonesia
+62 21 545674
A.Widyawati@elg.umcn.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1083202989605930

Study information

Scientific title

The Four Pillars Approach in managing pregnant women with anaemia in Yogyakarta-Indonesia

Acronym

FPA

Study hypothesis

It is hypothesised that the Four Pillars Approach will be effective in improving the outcomes for pregnant women with anaemia vs. usual care.

The null hypothesis is that there will be no difference in outcomes between treatment and control groups, this may arise participant's compliance on the treatment is not monitored by the trained nurse-midwives.

Ethics approval

The Medical and Health Research Ethics Committee (MHREC), Ministry of National Education Faculty of Medicine Gadjah Mada University, December 15, 2011, ref: KE/FK/730/EC

Study design

Interventional case control study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Anaemia in pregnancy

Intervention

In an intervention study, the effectiveness of the Four Pillars Approach will be compared to usual care.

Training of the Four Pillars Approach to nurse midwives in treatment groups in Yogyakarta. The trained nurse midwives will implement the Four Pillars Approach to eligible participants during the period of six months. Participants will receive the booklet of anaemia in pregnancy and with their husbands or other family members will involve in parenting classes.

In this study, we use different location for treatment and control groups, but they have the similar characteristics of demography and population. We use 24 Public Health Center in each groups. Based on the sample size calculation, we need 360 participants totally. The participants enrollment will be done until the target number of participant in each Public Health Center is achieved. We use cluster for the target number of participants in each Public Health center in both groups, and we randomize the recruited participants.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. The difference of haemoglobin level
2. The number of antenatal care attendances
3. Skilled birth attendance at delivery

Haemoglobin level, the frequency of antenatal care will be measured at baseline (in first trimester of pregnancy) and after six months of intervention (in the third trimester of pregnancy); and the presence of skilled birth attendance during labour will be monitored in delivery process.

Secondary outcome measures

1. The barriers and facilitating factors of the implementation of the Four Pillars Approach
2. Patient's and nurse-midwives' satisfaction with the approach.

Evaluated after six months of intervention

Overall trial start date

01/05/2012

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant women with a haemoglobin (Hb) of less than 11 g/dl in the first trimester of pregnancy
2. Living with a husband or other family members

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

360

Participant exclusion criteria

Pregnant women over twelve weeks of gestation will be excluded

Recruitment start date

01/05/2012

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Indonesia

Trial participating centre

PSIK FK UGM
Yogyakarta
55281
Indonesia

Sponsor information

Organisation

Radboud University Medical Centre Nijmegen (Netherlands)

Sponsor details

UMC St Radboud Centraal
route 117
Geert Grooteplein 21
P.O. box 9101
Nijmegen
6500 HB
Netherlands
+31 24 361 9106
a.lagro-janssen@elg.umcn.nl

Sponsor type

Hospital/treatment centre

Website

http://www.vrouwenstudiesgeneeskunde.nl/

Funders

Funder type

Government

Funder name

Directorate General of Higher Education Ministry of National Education of Republic of Indonesia (Indonesia) ref.: 369/E4.4/K/2011

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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24884497

Publication citations

  1. Protocol

    Widyawati W, Jans S, Bor H, Siswishanto R, van Dillen J, Lagro-Janssen AL, A randomised controlled trial on the Four Pillars Approach in managing pregnant women with anaemia in Yogyakarta-Indonesia: a study protocol., BMC Pregnancy Childbirth, 2014, 14, 163, doi: 10.1186/1471-2393-14-163.

Additional files

Editorial Notes