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

Not Applicable

Recruiting

• Conditions: Meconium-stained Amniotic Fluid; Chorioamnionitis
• Interventions: Drug: zinacef tretment; Other: Placebo

• Registration Number: NCT06849037
• Lead Sponsor: Western Galilee Hospital-Nahariya

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.

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 Timeline

• Study First Submitted: 2025-02-15
• Study Start: 2025-02-18
• Study First Submitted QC: 2025-02-22
• Study First Posted: 2025-02-27
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-20
• Primary Completion: 2028-02-13
• Study Completion: 2029-02-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 182

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zinacef treatment	zinacef tretment	women with meconium-stained amniotic fluid treated with zinacef 750 mg X3/d
control	Placebo	women with meconium-stained amniotic fluid treated with I.V SALINE 100 CCX3/d

Primary Outcome Measures

Name	Time	Method
peripartum infections	7 days	chorioamnionitis and endometritis

Secondary Outcome Measures

Name	Time	Method
intrapartum fever	during labor up to 2 hours postpartum	fever \> 38
neonatal antibiotic treatment	7 days	antibiotic treatment
NICU admission	1 week	neonatal admission to the NICU after delivery

Trial Locations

Locations (1)

Galilee Medical center; 🇮🇱 Nahariyya, Israel