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

Western Galilee Hospital-Nahariya

Status: Enrolling

Conditions: Chorioamnionitis; Meconium-stained Amniotic Fluid

Treatments: Drug: zinacef tretment; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06849037

NHR-0242-24

MOH_2025-01-30_013876 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 182 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• singleton pregnancy at term
• meconium-stained amniotic fluid

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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182 participants in 2 patient groups, including a placebo group

Zinacef treatment

Experimental group

Description:

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

Treatment:

Drug: zinacef tretment

control

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo