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

ISRCTN	ISRCTN35822126
DOI	https://doi.org/10.1186/ISRCTN35822126
Secondary identifying numbers	1083202989605930

Submission date: 25/04/2013
Registration date: 07/05/2013
Last edited: 03/06/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Haematological Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Ms Widyawati Widyawati
Scientific

PSIK FK UGM
Gedung Ismangoen Lt. 2
Jl. Farmako, Sekip Utara
Yogyakarta
55281
Indonesia

Phone	+62 21 545674
Email	A.Widyawati@elg.umcn.nl

Study information

Study design	Interventional case control study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The Four Pillars Approach in managing pregnant women with anaemia in Yogyakarta-Indonesia
Study acronym	FPA
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	01/05/2012
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	360
Key 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
Key exclusion criteria	Pregnant women over twelve weeks of gestation will be excluded
Date of first enrolment	01/05/2012
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Indonesia

Study participating centre

PSIK FK UGM

Yogyakarta
55281
Indonesia

Sponsor information

Radboud University Medical Centre Nijmegen (Netherlands)
Hospital/treatment centre

UMC St Radboud Centraal, route 117
Geert Grooteplein 21
P.O. box 9101
Nijmegen
6500 HB
Netherlands

Phone	+31 24 361 9106
Email	a.lagro-janssen@elg.umcn.nl
Website	http://www.vrouwenstudiesgeneeskunde.nl/
"ROR"	https://ror.org/05wg1m734

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	07/05/2014		Yes	No