Comparing Infectious Morbidity Among Women With Meconium-stained Amniotic Fluid at Term, Between Those Treated With Prophylactic Antibiotics Zinacef vs. Placebo

July 16, 2025 updated by: Dr. Maya Wolf, Western Galilee Hospital-Nahariya

and Infectious Morbidity Among Women With Meconium-stained Amniotic Fluid at Term, Between Those Who Will be Treated With Prophylactic Antibiotics Zinacef vs. Placebo

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The relationship between meconium staining and chorioamnionitis, as well as neonatal sepsis, has been documented, yet the precise mechanisms remain unclear. Additionally, the correlation between prolonged labor and meconium staining was described in the past. In light of these findings, our randomized controlled double blind trail aims to compare maternal and neonatal infectious morbidity between women with meconium-stained amniotic fluid treated with zinacef vs. placebo. Additionally, we aimed to assess the distribution of pathogens in chorioamnionitic swab cultures relative to the antibiotic treatment

Study Type

Interventional

Enrollment (Estimated)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maya Frank Wolf, Prof.
  • Phone Number: 972-50-7887800
  • Email: mayaw@gmc.gov.il

Study Locations

  • Israel
      • Nahariyya, Israel
        • Recruiting
        • Galilee Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • singleton pregnancy at term
  • meconium-stained amniotic fluid

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zinacef treatment
women with meconium-stained amniotic fluid treated with zinacef 750 mg X3/d
Drug: zinacef tretment
prophylactic antibiotic treatment with zinacef
Placebo Comparator: control
women with meconium-stained amniotic fluid treated with I.V SALINE 100 CCX3/d
Other: Placebo
I.V SALINE 100 CC X3/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
peripartum infections
Time Frame: 7 days
chorioamnionitis and endometritis
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neonatal antibiotic treatment
Time Frame: 7 days
antibiotic treatment
7 days
NICU admission
Time Frame: 1 week
neonatal admission to the NICU after delivery
1 week
intrapartum fever
Time Frame: during labor up to 2 hours postpartum
fever > 38
during labor up to 2 hours postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Galilee Hospital-Nahariya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2025

Primary Completion (Estimated)

February 13, 2028

Study Completion (Estimated)

February 13, 2029

Study Registration Dates

First Submitted

February 15, 2025

First Submitted That Met QC Criteria

February 22, 2025

First Posted (Actual)

February 27, 2025

Study Record Updates

Last Update Posted (Actual)

July 20, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHR-0242-24
  • MOH_2025-01-30_013876 (Other Identifier: MOH-Israel)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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