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NCT Number: NCT06849037

Comparing Infectious Morbidity Among Women With Meconium-stained Amniotic Fluid at Term, Between Those 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.

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Key information

Conditions

Meconium-stained Amniotic Fluid Chorioamnionitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Membranes, Premature Rupture Obstetric Labor Complications Placenta Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • singleton pregnancy at term
  • meconium-stained amniotic fluid

Exclusion criteria

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

Treatment and study plan

zinacef tretment

Drug

prophylactic antibiotic treatment with zinacef

Placebo

Other

I.V SALINE 100 CC X3/d

Primary outcomes

  1. peripartum infections

    Time frame: 7 days

    chorioamnionitis and endometritis

Secondary outcomes

  1. intrapartum fever

    Time frame: during labor up to 2 hours postpartum

    fever > 38

  2. neonatal antibiotic treatment

    Time frame: 7 days

    antibiotic treatment

  3. NICU admission

    Time frame: 1 week

    neonatal admission to the NICU after delivery

Study contacts

Contact information is provided by the study sponsor or research team.

Maya Frank Wolf, prof.

CONTACT

[email protected]

972-50-7887800

Sponsors and collaborators

Lead sponsor

Western Galilee Hospital-Nahariya

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Feb 27, 2025
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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