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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWestern Galilee Hospital-Nahariya

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

singleton pregnancy at term

meconium-stained amniotic fluid

Disqualifiers

Intrauterine fetal death

GBS carriers

zinacef allergy

antibiotic treatment for other indication

Trial design

Design model

Parallel

Treatments tested in this trial

  • zinacef tretment

    Drug

    prophylactic antibiotic treatment with zinacef

  • Placebo

    Other intervention

    I.V SALINE 100 CC X3/d

Treatment groups

182 Participants
are divided into 2 treatment groups
Group A: Zinacef treatmentExperimental treatment 1 intervention
Group B: controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

peripartum infections

chorioamnionitis and endometritis

Time frame
7 days

Secondary outcomes

1

intrapartum fever

fever \> 38

Time frame
during labor up to 2 hours postpartum
2

neonatal antibiotic treatment

antibiotic treatment

Time frame
7 days
3

NICU admission

neonatal admission to the NICU after delivery

Time frame
1 week

Other outcomes

Sponsors and contacts

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