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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]

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

Maternal Anaemia

Condition category

Condition code

Reproductive Health and Childbirth

Antenatal care

Blood

Anaemia

Reproductive Health and Childbirth

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]

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]

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]

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]

2. Proportion of children born with low birth weight (less than or equal to 2500g) assessed by measuring birth weight.

Timepoint [2]

Measured with 72 hours after delivery

Secondary outcome [1]

Proportion of pregnant women with low BMI calculated by measuring height and weight

Timepoint [1]

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]

Pakistan

State/province [1]

UMERKOT AND THARPARKER/SINDH PROVINCE

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

UNICEF

Address [1]

UNICEF SINDH PAKISTAN

Country [1]

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]

Individual

Name [1]

Dr. Sarwat Mirza

Address [1]

Chief Health, Research & Development Executive
Health and Nutrition Development Society (HANDS)
Karachi, Pakistan

Country [1]

Pakistan

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

National Bioethics Committee. Pakistan Medical Research Council

Ethics committee address [1]

Pakistan Medical Research Council, Shahrae- Jamhuriat, Off Constitutional Avenue, Sector G-5/2, Islamabad, Pakistan

Ethics committee country [1]

Pakistan

Date submitted for ethics approval [1]

12/03/2012

Approval date [1]

30/04/2012

Ethics approval number [1]

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]

/AnzctrAttachments/371274-NBC-Approval.pdf (Ethics approval)

Contacts

Principal investigator

Name

Dr Ahsan Ahmad

Address

Health Services Academy
Opposite National Institute of Health (NIH)
Chak Shahzad, Islamabad, Pakistan

Country

Pakistan

Phone

+92519255590

Fax

drahsen@yahoo.com

Contact person for public queries

Name

Ahsan Ahmad

Address

Health Services Academy
Opposite National Institute of Health (NIH)
Chak Shahzad, Islamabad, Pakistan

Country

Pakistan

Phone

+92519255590

Fax

drahsen@yahoo.com

Contact person for scientific queries

Name

Ahsan Ahmad

Address

Health Services Academy
Opposite National Institute of Health (NIH)
Chak Shahzad, Islamabad, Pakistan

Country

Pakistan

Phone

0092519255590

Fax

drahsen@yahoo.com

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

Source	Title	Year of Publication	DOI
Embase	Multiple-micronutrient supplementation for women during pregnancy.	2019	https://dx.doi.org/10.1002/14651858.CD004905.pub6

N.B. These documents automatically identified may not have been verified by the study sponsor.

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