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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06849037

Enrollment

182

Registered

2025-02-27

Start date

2025-02-18

Completion date

2028-02-13

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chorioamnionitis, Meconium-stained Amniotic Fluid

Keywords

meconium-stained amniotic fluid, antibiotic treatment, infectious morbidity, chorioamnionitis, zinacef

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

Interventions

DRUGzinacef tretment

prophylactic antibiotic treatment with zinacef

OTHERPlacebo

I.V SALINE 100 CC X3/d

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Single masking - Participant

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* singleton pregnancy at term * meconium-stained amniotic fluid

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
peripartum infections	7 days	chorioamnionitis and endometritis

Secondary

Measure	Time frame	Description
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

Countries

Israel

Contacts

CONTACTMaya Frank Wolf, prof.

mayaw@gmc.gov.il972-50-7887800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026