- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07531134
The Impact of Extreme Environmental and Security Conditions on Prematurity and Low Birth Weight Rates
Do Extreme Environmental and Security-related Conditions Affect the Rates of Prematurity and Low Birth Weight?
Numerous reports indicate that various extreme environmental and security-related situations during pregnancy may increase the risk of prematurity, LBW, and miscarriage, as these events increase both the incidence and intensity of maternal stress.
Study Objective: To map and validate this phenomenon within the catchment area of the Hillel Yaffe Medical Center.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background Prematurity accounts for approximately 10% of all births. A preterm infant is defined as a baby born before 37 completed weeks of gestation, calculated from the first day of the last menstrual period (LMP). Low birth weight (LBW) is defined as a birth weight below 2,500 grams. Both prematurity and LBW are associated with various early and late complications, the frequency and severity of which increase as gestational age and birth weight decrease.
Numerous reports indicate that various extreme environmental and security-related situations during pregnancy may increase the risk of prematurity, LBW, and miscarriage, as these events increase both the incidence and intensity of maternal stress. Examples of such conditions include pandemics, wars, economic collapses, and environmental disasters, such as earthquakes or storms. In instances of economic collapse, the impact manifests more frequently as fetal growth restriction (FGR) than as prematurity. Pandemics are more closely associated with prematurity, although some reports indicated a decrease in prematurity rates during the COVID-19 pandemic - likely due to a reduction in the diagnosis of pregnancy complications -with a concurrent increase in miscarriage rates.
These situations are characterized by unexpected changes in residence, decreased food security, shifts in disease vectors, socioeconomic instability, and alterations in air quality, temperature, and precipitation, all of which can impact expectant mothers. An additional factor is the diversion of medical resources toward emergency needs during these events, often at the expense of routine prenatal care.
Study Objective: To map and validate this phenomenon within the catchment area of the Hillel Yaffe Medical Center. This study aims to examine the correlation between the occurrence of extreme environmental and significant security events in Israel and the increase in the rate of preterm and LBW infants at our center.
Israel experiences natural extreme environmental events, economic crises, and pandemics, similar to the rest of the world. Additionally, security-related emergencies (wars and military operations) occur in Israel with high frequency.
Annual birth data is regularly published. Furthermore, the Israel Neonatal Association has maintained a database of all infants born weighing 1,500 grams or less since 1995. Comprehensive birth data from Hillel Yaffe Medical Center is fully available to the research team. By cross-referencing this data, we can investigate the link between maternal exposure to extreme conditions and neonatal outcomes. This is a preliminary study focusing on our center's birth population; if significant correlations are identified, a larger-scale national study may follow.
________________________________________ Methods Initially, the researchers will precisely define the events categorized as "extreme environmental and security situations" and establish the specific timeframes for these periods.
Data Collection:
Data will be collected regarding:
- Total number of births.
- Incidence of prematurity and infants Small for Gestational Age (SGA).
- Relevant demographic data.
Statistical Analysis:
The study will compare data from "event periods" against "routine/calm periods." As this is a population-based study rather than a sample, standard sampling discussions are not applicable.
- Normal Distribution: If data are normally distributed, the Z-test will be used.
- Non-Normal Distribution: Non-parametric tests (Wilcoxon, Mann-Whitney, etc.) will be employed.
- Categorical Data: The Chi-square (χ2) test will be used for comparisons.
- Significance: Statistical significance will be defined as p < 0.05.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Hadera, Israel, 38100
- Hillel Yaffe Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criterion:
All infants born in Hillel Yaffe medical center since 01/01/1995
Exclusion criteria:
None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
extreme environmental and security-related situations
pandemics, wars, economic collapses, and environmental disasters, such as earthquakes or storms
|
Only collecting the number of newborn infants in each group.
No intervention
|
|
No extreme environmental and security-related situations
All other times
|
Only collecting the number of newborn infants in each group.
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prematurity OR LBW rate per month
Time Frame: 25 years
|
prematurity or low birth weight rate
|
25 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erez Nadir, MD, Hillel Yaffe Medical Center
Publications and helpful links
General Publications
- Lawler K, Behie A, Richardson A. A systematic review with meta-analysis on the effects of maternal exposure to natural disasters on human birth outcomes. Int J Hyg Environ Health. 2025 Sep;270:114670. doi: 10.1016/j.ijheh.2025.114670. Epub 2025 Sep 22.
- Harville EW, Xiong X, David M, Buekens P. The Paradoxical Effects of Hurricane Katrina on Births and Adverse Birth Outcomes. Am J Public Health. 2020 Oct;110(10):1466-1471. doi: 10.2105/AJPH.2020.305769. Epub 2020 Aug 20.
- Yao XD, Zhu LJ, Yin J, Wen J. Impacts of COVID-19 pandemic on preterm birth: a systematic review and meta-analysis. Public Health. 2022 Dec;213:127-134. doi: 10.1016/j.puhe.2022.10.015. Epub 2022 Oct 19.
- Nagel LE, Reisch B, Schwenk U, Kimmig KR, Darkwah Oppong M, Dzietko M, Gellhaus A, Iannaccone A. Impact of 2 years of COVID-19 pandemic on preterm birth: Experience from a tertiary center of obstetrics in western Germany. Int J Gynaecol Obstet. 2024 Jul;166(1):404-411. doi: 10.1002/ijgo.15379. Epub 2024 Jan 17.
- Riquelme-Gallego B, Ramos-Soberbio L, Leno-Duran E, Martinez-Vazquez S, Caparros-Gonzalez RA. Adverse fetal and neonatal impact of war conflicts during pregnancy: A systematic review. IUBMB Life. 2025 Feb;77(2):e70006. doi: 10.1002/iub.70006.
- Bouachba A, Gorincour G, Charlier P, Ville Y. Pregnancy in Times of War: What Are the Fallouts? A Review. Fetal Diagn Ther. 2024;51(6):559-570. doi: 10.1159/000540508. Epub 2024 Jul 24.
- Cheung PY, Alshaikh B, Yang C. COVID-19 Pandemic: Different Associative Relationships of City Lockdown With Preterm Births in Three Cities - An Ecological Study. Front Pediatr. 2021 Apr 15;9:644771. doi: 10.3389/fped.2021.644771. eCollection 2021.
- Eiriksdottir VH, Asgeirsdottir TL, Bjarnadottir RI, Kaestner R, Cnattingius S, Valdimarsdottir UA. Low birth weight, small for gestational age and preterm births before and after the economic collapse in Iceland: a population based cohort study. PLoS One. 2013 Dec 4;8(12):e80499. doi: 10.1371/journal.pone.0080499. eCollection 2013.
- Hochard J, Li Y, Abashidze N. Associations of hurricane exposure and forecasting with impaired birth outcomes. Nat Commun. 2022 Nov 8;13(1):6746. doi: 10.1038/s41467-022-33865-x.
- Staude B, Misselwitz B, Louwen F, Rochwalsky U, Oehmke F, Kohler S, Maier RF, Windhorst AC, Ehrhardt H. Characteristics and Rates of Preterm Births During the COVID-19 Pandemic in Germany. JAMA Netw Open. 2024 Sep 3;7(9):e2432438. doi: 10.1001/jamanetworkopen.2024.32438.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0015-26-HYMC-IL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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