NCT06849037

Brief Summary

Our randomized controlled double blind clinical trail aims to compare maternal and neonatal infectious morbidity between women with meconium-stained amniotic fluid treated with zinacef vs. placebo.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
34mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress30%
Feb 2025Feb 2029

First Submitted

Initial submission to the registry

February 15, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

February 18, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2029

Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

February 15, 2025

Last Update Submit

July 16, 2025

Conditions

Meconium-stained Amniotic FluidChorioamnionitis

Keywords

meconium-stained amniotic fluidantibiotic treatmentinfectious morbiditychorioamnionitiszinacef

Outcome Measures

Primary Outcomes (1)

  • peripartum infections

    chorioamnionitis and endometritis

    7 days

Secondary Outcomes (3)

  • intrapartum fever

    during labor up to 2 hours postpartum

  • neonatal antibiotic treatment

    7 days

  • NICU admission

    1 week

Study Arms (2)

Zinacef treatment

EXPERIMENTAL

women with meconium-stained amniotic fluid treated with zinacef 750 mg X3/d

Drug: zinacef tretment

control

PLACEBO COMPARATOR

women with meconium-stained amniotic fluid treated with I.V SALINE 100 CCX3/d

Other: Placebo

Interventions

zinacef tretmentDRUG

prophylactic antibiotic treatment with zinacef

Zinacef treatment
PlaceboOTHER

I.V SALINE 100 CC X3/d

control

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnanct women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • singleton pregnancy at term
  • meconium-stained amniotic fluid

You may not qualify if:

  • Intrauterine fetal death
  • GBS carriers
  • zinacef allergy
  • antibiotic treatment for other indication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Galilee Medical center

Nahariya, Israel

RECRUITING

Related Publications (5)

  • Romero R, Hanaoka S, Mazor M, Athanassiadis AP, Callahan R, Hsu YC, Avila C, Nores J, Jimenez C. Meconium-stained amniotic fluid: a risk factor for microbial invasion of the amniotic cavity. Am J Obstet Gynecol. 1991 Mar;164(3):859-62. doi: 10.1016/0002-9378(91)90529-z.

    PMID: 1900664BACKGROUND

  • Attali I, Korb D, Azria E, Lepercq J, Goffinet F, Schmitz T; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Meconium-stained amniotic fluid and neonatal morbidity in nulliparous patients with prolonged pregnancy. Acta Obstet Gynecol Scand. 2023 Aug;102(8):1092-1099. doi: 10.1111/aogs.14619. Epub 2023 Jun 28.

    PMID: 37377254BACKGROUND

  • Rodriguez Fernandez V, Lopez Ramon Y Cajal CN, Marin Ortiz E, Couceiro Naveira E. Intrapartum and perinatal results associated with different degrees of staining of meconium stained amniotic fluid. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:65-70. doi: 10.1016/j.ejogrb.2018.03.035. Epub 2018 Mar 20.

    PMID: 29909265BACKGROUND

  • Addisu D, Asres A, Gedefaw G, Asmer S. Prevalence of meconium stained amniotic fluid and its associated factors among women who gave birth at term in Felege Hiwot comprehensive specialized referral hospital, North West Ethiopia: a facility based cross-sectional study. BMC Pregnancy Childbirth. 2018 Oct 30;18(1):429. doi: 10.1186/s12884-018-2056-y.

    PMID: 30376814BACKGROUND

  • Gallo DM, Romero R, Bosco M, Gotsch F, Jaiman S, Jung E, Suksai M, Ramon Y Cajal CL, Yoon BH, Chaiworapongsa T. Meconium-stained amniotic fluid. Am J Obstet Gynecol. 2023 May;228(5S):S1158-S1178. doi: 10.1016/j.ajog.2022.11.1283. Epub 2023 Apr 1.

    PMID: 37012128BACKGROUND

MeSH Terms

Conditions

Chorioamnionitis

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal Membranes, Premature RuptureObstetric Labor ComplicationsPlacenta DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Maya Frank Wolf, prof.

CONTACT

972-50-7887800mayaw@gmc.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Maternal and Fetal medicine unit

Study Record Dates

First Submitted

February 15, 2025

First Posted

February 27, 2025

Study Start

February 18, 2025

Primary Completion (Estimated)

February 13, 2028

Study Completion (Estimated)

February 13, 2029

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR

Locations

IL(1)