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

Effect of multi aspect interventions in reduction of low birth weight incidence and maternal anemia during pregnancy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001449426
Enrollment
1204
Registered
2016-10-17
Start date
2013-07-04
Completion date
2013-10-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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

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.

Sponsors

Dr Inayat Thaver
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
15 Years to 49 Years
Healthy volunteers
Yes

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026