NCT07531134

Brief 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. Study Objective: To map and validate this phenomenon within the catchment area of the Hillel Yaffe Medical Center.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
30mo left

Started Jan 1990

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jan 1990Dec 2028

Study Start

First participant enrolled

January 1, 1990

Completed
36.3 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

37.9 years

First QC Date

April 6, 2026

Last Update Submit

April 11, 2026

Conditions

Keywords

low birth weightprematurityextreme environmental and security-related situations

Outcome Measures

Primary Outcomes (1)

  • Prematurity OR LBW rate per month

    prematurity or low birth weight rate

    25 years

Study Arms (2)

extreme environmental and security-related situations

pandemics, wars, economic collapses, and environmental disasters, such as earthquakes or storms

Other: No intervention

No extreme environmental and security-related situations

All other times

Other: No intervention

Interventions

Only collecting the number of newborn infants in each group. No intervention

No extreme environmental and security-related situationsextreme environmental and security-related situations

Eligibility Criteria

AgeUp to 1 Day
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All infants born in Hillel Yaffe medical center since 01/01/1995

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe medical center

Hadera, 38100, Israel

Location

Related Publications (10)

  • 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.

    PMID: 40987029BACKGROUND
  • 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.

    PMID: 32816548BACKGROUND
  • 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.

    PMID: 36410118BACKGROUND
  • 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.

    PMID: 38230894BACKGROUND
  • 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.

    PMID: 39981676BACKGROUND
  • 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.

    PMID: 39047700BACKGROUND
  • 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.

    PMID: 33937150BACKGROUND
  • 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.

    PMID: 24324602BACKGROUND
  • 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.

    PMID: 36347839BACKGROUND
  • 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.

    PMID: 39254973BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Erez Nadir, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neonatologist

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 15, 2026

Study Start

January 1, 1990

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Confident data

Locations