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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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.

Israel1 site
  • Hillel Yaffe medical center

    Hadera, 38100

Other trials in Israel

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.
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 groups in NCT07531134
Study groupRoleWhat they receive
extreme environmental and security-related situationspandemics, wars, economic collapses, and environmental disasters, such as earthquakes or storms
Receives: Other: No intervention
No extreme environmental and security-related situationsAll other times
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted15 Apr 2026
  2. Study start1 Jan 1990
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Resources

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)
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 40987029
  • 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.

    PubMed 32816548
  • 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.

    PubMed 36410118
  • 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.

    PubMed 38230894
  • 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.

    PubMed 39981676
  • 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.

    PubMed 39047700
  • 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.

    PubMed 33937150
  • 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.

    PubMed 24324602
  • 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.

    PubMed 36347839
  • 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.

    PubMed 39254973

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