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Background :
It is important to tackle the issue of malnutrition at an early stage. A stunted mother has a tendency of having adverse neonatal outcomes including growth restriction. The multidisciplinary intervention followed by micronutrient supplementation is developed to prevent these adverse outcomes. Zinc has been associated with better neonatal growth and brain growth. This study aims to assess the impact of family-based health education programs plus zinc supplementation on the important biomarker of pregnancy and neonatal growth.
Objective :
Methodology :
A Quasi-experimental study involving stunted pregnant mother with parallel intervention
Hypothesis :
Mother who receives the intervention will have the better maternal and neonatal outcome
Details of Family-Based Health Education Program + Zinc :
General target population :
Design of Study :
two arms quasi-experimental study with one group receiving the intervention and comparison receiving standard Antenatal Care. The baseline measurement is conducted at the beginning of the third trimester, followed by the day of delivery and 6 months after delivery (for assessing the outcome of the infant). Participants are matched by certain variables
Variable :
List of outcomes
Sample size using the difference between two means of neonatal birth weight who received zinc and did not receive zinc according to a study in Iran
Proposed statistical analysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | This group will receive
|
|
| Control | Active Comparator | Standard antenatal care for third trimester will be applied without supplementation of zinc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc | Dietary Supplement | Zinc is given as written in the arm description, two hours after lunch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infant weight | This includes weight at birth, weight at 3 months and 6 months | changes of weight at birth up to 6 months |
| Infant Length | This includes length of body at birth, at 3 months and 6 months | changes of length at birth up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin level of mother | Hemoglobin level of mother measured in blood using hematology analyzer | changes of hemoglobin level of mother from the baseline to delivery time |
| Zinc level of mother in blood |
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Inclusion criteria
Exclusion Criteria
This study focus on a pregnant woman
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Halisah Halisah, M.Keb | Contact | +6285341247477 | armiyatinur@gmail.com | |
| Halisah Halisah, M.Keb | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Agussalim Bukhari, MD.Ph.D | Hasanuddin University | Principal Investigator |
| Nurpudji A Taslim, Prof | Hasanuddin University | Principal Investigator |
| Aidah Baso, MD. Ph.D |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hasanuddin University Medical Research Center / HUMRC | Recruiting | Makassar | South Sulawesi | 90245 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33676424 | Background | Boskabadi H, Maamouri G, Akhondian J, Ashrafzadeh F, Boskabadi A, Faramarzi R, Heidar E, Pourbadakhshan N, Shojaei SRH, Zakerihamidi M, Vatanchi AM, Sokhtanloo M, Razaghi N, Kalani F, Ataei H, Darabi A, Mousavi MS, Hakimiakhangan S, Bagheri F. Comparison of birth weights of neonates of mothers receiving vs. not receiving zinc supplement at pregnancy. BMC Pregnancy Childbirth. 2021 Mar 6;21(1):187. doi: 10.1186/s12884-021-03598-8. | |
| 27754451 |
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Deidentified data will be shared accordingly
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| ID | Term |
|---|---|
| D006130 | Growth Disorders |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
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| ID | Term |
|---|---|
| D015032 | Zinc |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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One group is assigned for health education intervention and zinc supplementation, and the comparison group receives only standard antenatal care.
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| Control | Other | This group will not receive zinc |
|
Zinc level of mother measured in blood using hematology analyzer
| changes of Zinc in blood of mother from the baseline to 6 months after delivery |
| Zinc level of mother in breast milk | Zinc level of mother measured in blood using atomic absorption spectrometric | changes of Zinc in breast milk of mother from the delivery day to 6 months after delivery |
| Hemoglobin level of infant | Hemoglobin level of infant measured in blood using hematology analyzer | changes of hemoglobin level of infant from the day of birth to 6 months |
| Insulin-like growth factor 1 (IGF-1) of mother | Insulin-like growth factor 1 (IGF-1) of mother measured in blood using Human IGF-1 enzyme-linked Immunosorbent Assay (ELISA) | changes of IGF-1 level of mother from the baseline to day of delivery |
| Insulin-like growth factor 1 (IGF-1) of infant | Insulin-like growth factor 1 (IGF-1) of infant measured in blood using Human IGF-1 enzyme-linked Immunosorbent Assay (ELISA) | changes of IGF-1 level of infant from the day of birth to 6 months |
| Brain-derived neurotrophic Factor (BDNF) of infant | Brain-derived neurotrophic Factor (BDNF) of infant measured in blood using enzyme-linked Immunosorbent Assay (ELISA) | changes of BDNF level of infant from the day of birth to 6 months |
| Tumor Growth Factor Beta 1 (TGF beta 1) of infant | Tumor Growth Factor Beta 1 (TGF beta 1) of infant measured in blood using enzyme-linked Immunosorbent Assay (ELISA) | changes of TGF Beta 1 level of infant from the day of birth to 6 months |
| Hasanuddin University |
| Principal Investigator |
| Sitti MT Chalid, MD. Ph.D | Hasanuddin University | Principal Investigator |
| Kadek Erika, RN | Hasanuddin University | Principal Investigator |
| Nasrudin Mappaware, MD | Muslim University Indonesia | Principal Investigator |
| Mardiana Ahmad, MD | Hasanuddin University | Principal Investigator |
| Firdaus Hamid, MD. Ph.D | Hasanuddin University | Principal Investigator |
| Suryani As'ad, Prof | Hasanuddin University | Principal Investigator |
| Rosdiana Natsir, Prof | Hasanuddin University | Principal Investigator |
| Martira Maddepungeng, MD | Hasanuddin University | Principal Investigator |
| Rian Pamungkas, RN, Ph.D | Esa Unggul University | Principal Investigator |
| Halisah Wahyuningsih, MW. | Hasanuddin University | Principal Investigator |
| Wahyuningsih Wahyuningsih, RN | Hasanuddin University | Principal Investigator |
| Armiyati Nur, MW | Hasanuddin University | Principal Investigator |
| Background |
| Wilson RL, Grieger JA, Bianco-Miotto T, Roberts CT. Association between Maternal Zinc Status, Dietary Zinc Intake and Pregnancy Complications: A Systematic Review. Nutrients. 2016 Oct 15;8(10):641. doi: 10.3390/nu8100641. |
| 29143677 | Background | Prata N, Tavrow P, Upadhyay U. Women's empowerment related to pregnancy and childbirth: introduction to special issue. BMC Pregnancy Childbirth. 2017 Nov 8;17(Suppl 2):352. doi: 10.1186/s12884-017-1490-6. No abstract available. |
| 25527182 | Background | Finch CW. Review of trace mineral requirements for preterm infants: what are the current recommendations for clinical practice? Nutr Clin Pract. 2015 Feb;30(1):44-58. doi: 10.1177/0884533614563353. Epub 2014 Dec 19. |
| 26365330 | Background | Zahiri Sorouri Z, Sadeghi H, Pourmarzi D. The effect of zinc supplementation on pregnancy outcome: a randomized controlled trial. J Matern Fetal Neonatal Med. 2016;29(13):2194-8. doi: 10.3109/14767058.2015.1079615. Epub 2015 Sep 12. |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D008670 |
| Metals |