Comparing Infectious Morbidity Among Women With Meconium-stained Amniotic Fluid at Term, Between Those Treated With Prophylactic Antibiotics Zinacef vs. Placebo
NCT ID: NCT06849037
Last Updated: 2025-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
182 participants
INTERVENTIONAL
2025-02-18
2029-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Zinacef treatment
women with meconium-stained amniotic fluid treated with zinacef 750 mg X3/d
zinacef tretment
prophylactic antibiotic treatment with zinacef
control
women with meconium-stained amniotic fluid treated with I.V SALINE 100 CCX3/d
Placebo
I.V SALINE 100 CC X3/d
Interventions
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zinacef tretment
prophylactic antibiotic treatment with zinacef
Placebo
I.V SALINE 100 CC X3/d
Eligibility Criteria
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Inclusion Criteria
* meconium-stained amniotic fluid
Exclusion Criteria
* GBS carriers
* zinacef allergy
* antibiotic treatment for other indication
18 Years
FEMALE
Yes
Sponsors
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Western Galilee Hospital-Nahariya
OTHER_GOV
Responsible Party
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Dr. Maya Wolf
Head of Maternal and Fetal medicine unit
Locations
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Galilee Medical center
Nahariya, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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MOH_2025-01-30_013876
Identifier Type: OTHER
Identifier Source: secondary_id
NHR-0242-24
Identifier Type: -
Identifier Source: org_study_id
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