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RecruitingNCT06849037Updated Sep 15, 2026

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

An interventional study of zinacef tretment and Placebo in Meconium-stained Amniotic Fluid and Chorioamnionitis, sponsored by Western Galilee Hospital-Nahariya. Recruiting at 1 site in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Western Galilee Hospital-Nahariya · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
182
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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

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Conditions studied

  • Meconium-stained Amniotic Fluid
  • Chorioamnionitis

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Keywords

  • meconium-stained amniotic fluid
  • antibiotic treatment
  • infectious morbidity
  • chorioamnionitis
  • zinacef
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In context

Chorioamnionitis

39 studies on the registry are indexed under Chorioamnionitis; 9 are open to participants now.

This study's planned enrollment of 182 is above the median of 157 across 22 interventional studies indexed under Chorioamnionitis.

Browse Chorioamnionitis studies →

Lead sponsor

Western Galilee Hospital-Nahariya is the lead sponsor of 89 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • singleton pregnancy at term
  • meconium-stained amniotic fluid

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
182 participants (estimated)

Study arms

  • Experimental
    Zinacef treatment

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

    Drug: zinacef tretment

  • Placebo comparator
    control

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

    Other: Placebo

Interventions

  • Drugzinacef tretment

    prophylactic antibiotic treatment with zinacef

  • OtherPlacebo

    I.V SALINE 100 CC X3/d

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What researchers measure

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

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Romero R, Hanaoka S, Mazor M, Athanassiadis AP, Callahan R, Hsu YC, Avila C, Nores J, Jimenez C. Meconium-stained amniotic fluid: a risk factor for microbial invasion of the amniotic cavity. Am J Obstet Gynecol. 1991 Mar;164(3):859-62. doi: 10.1016/0002-9378(91)90529-z. PubMed 1900664 ↗
  • Attali I, Korb D, Azria E, Lepercq J, Goffinet F, Schmitz T; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Meconium-stained amniotic fluid and neonatal morbidity in nulliparous patients with prolonged pregnancy. Acta Obstet Gynecol Scand. 2023 Aug;102(8):1092-1099. doi: 10.1111/aogs.14619. Epub 2023 Jun 28. PubMed 37377254 ↗
  • Rodriguez Fernandez V, Lopez Ramon Y Cajal CN, Marin Ortiz E, Couceiro Naveira E. Intrapartum and perinatal results associated with different degrees of staining of meconium stained amniotic fluid. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:65-70. doi: 10.1016/j.ejogrb.2018.03.035. Epub 2018 Mar 20. PubMed 29909265 ↗
  • Addisu D, Asres A, Gedefaw G, Asmer S. Prevalence of meconium stained amniotic fluid and its associated factors among women who gave birth at term in Felege Hiwot comprehensive specialized referral hospital, North West Ethiopia: a facility based cross-sectional study. BMC Pregnancy Childbirth. 2018 Oct 30;18(1):429. doi: 10.1186/s12884-018-2056-y. PubMed 30376814 ↗
  • Gallo DM, Romero R, Bosco M, Gotsch F, Jaiman S, Jung E, Suksai M, Ramon Y Cajal CL, Yoon BH, Chaiworapongsa T. Meconium-stained amniotic fluid. Am J Obstet Gynecol. 2023 May;228(5S):S1158-S1178. doi: 10.1016/j.ajog.2022.11.1283. Epub 2023 Apr 1. PubMed 37012128 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Clinical study report

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06849037
Lead sponsor
Western Galilee Hospital-Nahariya
Responsible party
Dr. Maya Wolf (Head of Maternal and Fetal medicine unit, Western Galilee Hospital-Nahariya) — Principal investigator
First posted
Feb 27, 2025
Start date
Feb 18, 2025
Primary completion
Feb 13, 2027 (estimated)
Completion
Feb 13, 2028 (estimated)
Last update
Sep 15, 2026

Study contacts

Maya Frank Wolf, prof.
Contact
mayaw@gmc.gov.il
972-50-7887800

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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