Clinical trial NCT06849037: Comparing Infectious Morbidity Among Women with Meconium-stained Amniotic Fluid At Term, Between Those Treated with Prophylactic Antibiotics Zinacef Vs. Placebo
Official title: And Infectious Morbidity Among Women with Meconium-stained Amniotic Fluid At Term, Between Those Who Will Be Treated with Prophylactic Antibiotics Zinacef Vs. Placebo
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meconium-stained Amniotic Fluid
Chorioamnionitis
Keywords: meconium-stained amniotic fluid
antibiotic treatment
infectious morbidity
chorioamnionitis
zinacef
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2025-02-27
Enrollment: 182
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy at term
* meconium-stained amniotic fluid

Exclusion Criteria:

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

Primary outcomes:
measure: peripartum infections
timeFrame: 7 days
Secondary outcomes:
measure: intrapartum fever
timeFrame: during labor
measure: neonatal antibiotic treatment
timeFrame: 7 days
measure: NICU admission
timeFrame: 1 week
Other outcomes:
Locations:
city: Nahariyya
country: Israel
facility: Galilee Medical center
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.