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Trial registered on ANZCTR


Registration number
ACTRN12616001449426
Ethics application status
Approved
Date submitted
17/08/2016
Date registered
17/10/2016
Date last updated
17/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of multi aspect interventions in reducing Low birth weight and maternal anemia among pregnant women
Scientific title
Effect of multi aspect interventions in reduction of low birth weight incidence and maternal anemia during pregnancy
Secondary ID [1] 289898 0
None
Universal Trial Number (UTN)
U1111-1185-7680
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low birth weight
299861 0
Maternal Anaemia 300231 0
Condition category
Condition code
Reproductive Health and Childbirth 299767 299767 0 0
Antenatal care
Blood 299955 299955 0 0
Anaemia
Reproductive Health and Childbirth 299956 299956 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Provision of Multiple Micronutrient (MMN) supplementation and iron folate during pregnancy
Dose for MMN was 1 tablet daily orally after the first trimester throughout the pregnancy until delivery distributed through the Antenatal clinics or by Lady Health Workers. it consisted of Retinol (vitamin A) 800 retinol equivalents (re), Vitamin E 10 mg, Vitamin D 200 International Units (IU), Vitamin B1-1.4 mg, Vitamin B2 1.4 mg, Niacin 18 mg, Vitamin B6 1.9 mg, Vitamin B12 -2.6 microgram, Folic Acid 400 microgram, Vitamin C 70 mg, Iron 30 mg (as iron fumarate or iron sulphate), Zinc 15 mg (as zinc sulphate), Copper 2 mg, Selenium 65 microgram, Iodine 150 microgram
- Iron and Folate :60 mg iron + 400 microgram folic acid daily for 6 months as one tablet
Arm 2: De-worming of pregnant women in 2nd trimester
Where hookworms are endemic (prevalence 20-30% or more) give anti-helminthic treatment once in the second trimester of pregnancy. If hookworms are highly endemic (prevalence more than 50%), repeat anti-helminthic treatment in the third trimester of pregnancy. Drug and dose are as follows
Albendazole 400 mg single dose OR Mebendazole 500 mg single dose or 100 mg twice daily for 3 days as oral tablet
Micronutrient, Iron-Folate supplementation and de-worming was conducted according to the recommended protocols of WHO/UNICEF and The International Nutritional Anemia Consultative Group (INACG) .
Monitoring intake: Lady Health Workers provided multiple micro-nutrient tablets to each enrolled pregnant woman on monthly basis during follow-up visit. 35 tablets per month were provided to every enrolled pregnant women, along with counselling about dietary intake and MMN replenishment date. Contact numbers of research team members were shared with all the participating women for contacting the field team members in case of any problem/side effects from MMN. To ensure intake of MMNs, same methodology as used by DOTS (Direct Observation Treatment Strategy in Tuberculosis Treatment regimens) program was adopted. In this approach the mother in law or elderly woman in the house were made responsible to visually observe the enrolled pregnant women consuming MMN on a daily basis. Furthermore, LHWs visited households on a weekly/fortnightly basis and sometimes with Lady Health Supervisors and district teams to monitor supplement intake.

Arm 3: Nutrition/ health education and counseling to pregnant women and their families
Lady Health Workers conducted women group meetings on a monthly basis with the help of counselling material developed for this study. Those health education sessions were about maternal nutrition, health and hygiene, breastfeeding, use of iodized salt, de-worming etc. The sessions were attended by enrolled pregnant women, adolescents and young girls, and all married women of all families. LHWs recorded and reported number of sessions, number of participants and topic they covered
LHWs were conducting meetings at central place of village where all pregnant women had easy access. Sometimes she conducted meetings at her health house as well and she used diagrammatic flip charts to conduct the sessions. The sessions were on monthly basis lasted for 60 minutes.
Intervention code [1] 295581 0
Prevention
Comparator / control treatment
1. Health education sessions were part of routine activities of the Marvi workers in the segment where the Marvi workers were present. The second control arm where there were no Marvi workers , Community Facilitators (CFs) and the project staff provided information during their follow-up sessions. The Marvi workers were giving health education on general topics verbally, but not specifically on MNN and its usage while in the non-marvi workers areas, the project staff in a non-structured way gave information about the project and its purpose. This lead to minimum contamination of non-exposure status in relation to MMN among the non-intervention areas.
Control group
Active

Outcomes
Primary outcome [1] 299316 0
change in trends of maternal anemia (hemoglobin levels of greater and equal to 11 g/dl) from both intervention and non-intervention areas assessed by measuring Haemoglobin level .
This was measured using The Hemocue Hb 201+ System- A digital machine through which we can measure haemoglobin level within seconds.
Timepoint [1] 299316 0
1. Four times for each pregnant woman. First reading of Hb was taken at enrolment, second reading was taken on same calendar date after three months in second trimester, similarly third reading was taken on same date after three months in third trimester and fourth reading was taken within 72 hours of delivery.

Primary outcome [2] 299444 0
2. Proportion of children born with low birth weight (less than or equal to 2500g) assessed by measuring birth weight.
Timepoint [2] 299444 0
Measured with 72 hours after delivery
Secondary outcome [1] 326822 0
Proportion of pregnant women with low BMI calculated by measuring height and weight
Timepoint [1] 326822 0
Height was measured once at the time of enrolment and weight was measured four times for each pregnant woman. First reading was taken at enrolment, second reading was taken on same calendar date after three months in second trimester, similarly third reading was taken on same date after three months in third trimester and fourth reading was taken within 72 hours of delivery. . Weight was measured through SECA electronic weighing scale while height of enrolled pregnant women was taken through SECA stadiometer.

Eligibility
Key inclusion criteria
Pregnant women in second trimester (13-17 weeks of gestation)
give consent to be part of study
Minimum age
15 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
women who refused to be part of the study and did not gave consent
Women with high risk pregnancies

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive and Inferential statistics, uni-variable and multivariate regression analyses.
To conduct the follow-up intervention research, the sample size calculation was done so as to estimate the occurrence of low birth weight among the exposed (anemic) versus the non-exposed (non-anemic). There were no known estimates for
a. Anemia among child bearing age (CBAs) women (15-49 years) for the districts of Umerkot and Tharparker,
b. Estimates for the expected higher incidence of low birth weight among anemic and non-anemic women (Sindh or Pakistan).
c. The expected effect of LHW interventions on incidence of low birth weight among anemic women(in Sindh or for Pakistan)
This sample size calculation used the prevalence of 27.9% prevalence of anemia among women of child bearing age, resulting in a ratio of 3:1 for the unexposed vs non-exposed in the study population. Assuming the study power (1-Beta) to be 80% and Type I error to be 5% (i.e. Confidence interval of 95%), and the expected/detectable odds ratio of 1.5 (approximating to expected 50% higher incidence of low birth weight among anemic women versus non-anemic women) the sample size calculation revealed
The estimated sample size comes to 848 non-anemic married child bearing age women and 283 anemic married child bearing age women. The total suggested study participants for the intervention research hence totals to 1,272 married child bearing aged women across both Umerkot and Tharparker.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/07/2013
Date of last participant enrolment
Anticipated
Actual
31/10/2013
Date of last data collection
Anticipated
Actual
2/06/2014
Sample size
Target
1272
Accrual to date
Final
1204
Recruitment outside Australia
Country [1] 8110 0
Pakistan
State/province [1] 8110 0
UMERKOT AND THARPARKER/SINDH PROVINCE

Funding & Sponsors
Funding source category [1] 294333 0
Charities/Societies/Foundations
Name [1] 294333 0
UNICEF
Country [1] 294333 0
Pakistan
Primary sponsor type
Individual
Name
Dr Inayat Thaver
Address
Al- Shifa Trust, Al-Shifa school of public health, Grand Trunk Road, Rawalpindi, Pakistan
Country
Pakistan
Secondary sponsor category [1] 293170 0
Individual
Name [1] 293170 0
Dr. Sarwat Mirza
Address [1] 293170 0
Chief Health, Research & Development Executive
Health and Nutrition Development Society (HANDS)
Karachi, Pakistan
Country [1] 293170 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295753 0
National Bioethics Committee. Pakistan Medical Research Council
Ethics committee address [1] 295753 0
Pakistan Medical Research Council, Shahrae- Jamhuriat, Off Constitutional Avenue, Sector G-5/2, Islamabad, Pakistan
Ethics committee country [1] 295753 0
Pakistan
Date submitted for ethics approval [1] 295753 0
12/03/2012
Approval date [1] 295753 0
30/04/2012
Ethics approval number [1] 295753 0
4-87/12/NBC-91/RDC/3441

Summary
Brief summary
Community based prospective cohort design was adopted to conduct intervention versus non-intervention comparisons among rural non-agrarian and food insecure Tharparker and Umerkot districts of Pakistan. The set of interventions included nutrition/ health education and counselling to pregnant women, provision of Multiple Micro-nutrient (MMN) supplementation and iron folate during pregnancy, de-worming of pregnant women in second trimester and counselling to families for improving diet of pregnant women. Non-intervention areas consisted of two arms one arm consisted of Marvi workers and other where there were no Marvi workers, Project team along with Community Facilitators (CFs) enrolled the pregnant women. The Marvi workers were giving health education on general topics like antenatal care, newborn care etc. while in the non-marvi workers areas, the project staff in a non-structured way gave information about the project and its purpose. This lead to minimum contamination of non-exposure status in relation to MNN among the non-intervention areas. The study group included 1,204 (600 in intervention group and 604 in non-intervention group) currently pregnant women in their earlier weeks of pregnancy. The intervention areas were from Lady Health Worker (LHW) covered population (nearly half of the districts covered by the LHW program) and the non-intervention areas among non-LHW covered population. The enrollment and follow-up phase (3 visits to each enrolled woman) lasted for twelve months (June 2013-June 2014). The interventions were imparted through LHW’s in their covered area, while in the non-LHW covered area the local Marvi workers and research project staff through CFs conducted the follow up of the pregnant women in the non-intervention group. By the end of the follow-up phase, favorable dietary behavior changes were observed, as more than one third women in the intervention group (39.1%) and nearly half in the non-intervention group (45.6%) modified their diet during the current pregnancy. The set of interventions were given to each participant for nearly six months, and the changes in anthropometric measurements (Height and weight) and hemoglobin levels were regularly monitored during the follow up phase. It was observed that there was a significantly higher increase in mean Hb levels and Body Mass Index (BMI) of the women in the intervention arm as compared to non-intervention arm after 3 months and 6 months of interventions. Birth weight which was the main outcome for this study reflected the effect of project interventions, with newborns in the LHW areas having a statistically significantly higher mean birth weight (2.8 SD 0.30) in kilograms as compared to non-LHW areas (2.5 SD 0.31).
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1037 1037 0 0
/AnzctrAttachments/371274-NBC-Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 68154 0
Dr Ahsan Ahmad
Address 68154 0
Health Services Academy
Opposite National Institute of Health (NIH)
Chak Shahzad, Islamabad, Pakistan
Country 68154 0
Pakistan
Phone 68154 0
+92519255590
Fax 68154 0
Email 68154 0
[email protected]
Contact person for public queries
Name 68155 0
Ahsan Ahmad
Address 68155 0
Health Services Academy
Opposite National Institute of Health (NIH)
Chak Shahzad, Islamabad, Pakistan
Country 68155 0
Pakistan
Phone 68155 0
+92519255590
Fax 68155 0
Email 68155 0
[email protected]
Contact person for scientific queries
Name 68156 0
Ahsan Ahmad
Address 68156 0
Health Services Academy
Opposite National Institute of Health (NIH)
Chak Shahzad, Islamabad, Pakistan
Country 68156 0
Pakistan
Phone 68156 0
0092519255590
Fax 68156 0
Email 68156 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMultiple-micronutrient supplementation for women during pregnancy.2019https://dx.doi.org/10.1002/14651858.CD004905.pub6
N.B. These documents automatically identified may not have been verified by the study sponsor.