Effect of multi aspect interventions in reducing Low birth weight and maternal anemia among pregnant women

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001449426
• Date of registration: 17/10/2016
• Prospective Registration: No
• Primary sponsor: Dr Inayat Thaver
• 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
• Date of first enrolment: 04/07/2013
• Target sample size: 1272
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001449426.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 2

Countries of recruitment

Pakistan

Contacts

• Name: Dr Ahsan Ahmad

• Name: Dr Ahsan Ahmad

Key inclusion & exclusion criteria

Inclusion criteria: Pregnant women in second trimester (13-17 weeks of gestation)
give consent to be part of study
Exclusion criteria: women who refused to be part of the study and did not gave consent
Women with high risk pregnancies

Age minimum: 15 Years
Age maximum: 49 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Complications of newborn

Low birth weight ;Maternal Anaemia;
Low birth weight

Maternal Anaemia

Reproductive Health and Childbirth - Antenatal care

Blood - Anaemia

Intervention(s)

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

Primary Outcome(s)

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.
[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.

]

2. Proportion of children born with low birth weight (less than or equal to 2500g) assessed by measuring birth weight.[Measured with 72 hours after delivery ]

Secondary Outcome(s)

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

Secondary ID(s)

None

Source(s) of Monetary Support

UNICEF

Secondary Sponsor(s)

Dr. Sarwat Mirza

Ethics review

Status: Approved
Approval date:
Contact:

National Bioethics Committee. Pakistan Medical Research Council