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
Ms Widyawati Widyawati
PSIK FK UGM
Gedung Ismangoen Lt. 2
+62 21 545674
The Four Pillars Approach in managing pregnant women with anaemia in Yogyakarta-Indonesia
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.
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
Interventional case control study
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Anaemia in pregnancy
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.
Primary outcome measure
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
Overall trial end date
Reason abandoned (if study stopped)
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
Target number of participants
Participant exclusion criteria
Pregnant women over twelve weeks of gestation will be excluded
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
PSIK FK UGM
Radboud University Medical Centre Nijmegen (Netherlands)
UMC St Radboud Centraal
Geert Grooteplein 21
P.O. box 9101
+31 24 361 9106
Directorate General of Higher Education Ministry of National Education of Republic of Indonesia (Indonesia) ref.: 369/E4.4/K/2011
Funding Body Type
Funding Body Subtype
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
Basic results (scientific)
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24884497
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.