Low Birth WeightNCT07531134
The Impact of Extreme Environmental and Security Conditions on Prematurity and Low Birth Weight Rates
An observational study of Low Birth Weight and Prematurity, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Low Birth Weight, Prematurity
- How many people
- 100,000 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 1990to 1 Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 day
- All sexes
- Healthy volunteers accepted
- Child
Study population: All infants born in Hillel Yaffe medical center since 01/01/1995
Who may be able to join
- All infants born in Hillel Yaffe medical center since 01/01/1995
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Birth Weight, Prematurity
- Being tested
- No intervention
- Keywords
- low birth weight, prematurity, extreme environmental and security-related situations
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Only collecting the number of newborn infants in each group. No intervention
| Study group | Role | What they receive |
|---|---|---|
| extreme environmental and security-related situations | pandemics, wars, economic collapses, and environmental disasters, such as earthquakes or storms Receives: Other: No intervention | |
| No extreme environmental and security-related situations | All other times Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prematurity OR LBW rate per month
prematurity or low birth weight rate
Measured: 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Jan 1990
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Low Birth WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erez Nadir, MD, Hillel Yaffe Medical Center
- Investigators
- Erez Nadir, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531134
- Sponsor's protocol ID
- 0015-26-HYMC-IL
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confident data
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.
PubMed 40987029Harville 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.
PubMed 32816548Yao 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.
PubMed 36410118Nagel 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.
PubMed 38230894Riquelme-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.
PubMed 39981676Bouachba 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.
PubMed 39047700Cheung 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.
PubMed 33937150Eiriksdottir 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.
PubMed 24324602Hochard 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.
PubMed 36347839Staude 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.
PubMed 39254973