Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MOH_2025-01-30_013876 | Other Identifier | MOH-Israel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinacef treatment | Experimental | women with meconium-stained amniotic fluid treated with zinacef 750 mg X3/d |
|
| control | Placebo Comparator | women with meconium-stained amniotic fluid treated with I.V SALINE 100 CCX3/d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zinacef tretment | Drug | prophylactic antibiotic treatment with zinacef |
| |
| Measure | Description | Time Frame |
|---|---|---|
| peripartum infections | chorioamnionitis and endometritis | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| intrapartum fever | fever > 38 | during labor up to 2 hours postpartum |
| neonatal antibiotic treatment | antibiotic treatment | 7 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
pregnanct women
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Frank Wolf, prof. | Contact | 972-50-7887800 | mayaw@gmc.gov.il |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galilee Medical center | Recruiting | Nahariya | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1900664 | Background | 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. | |
| 37377254 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
double blind
| Placebo |
| Other |
I.V SALINE 100 CC X3/d |
|
| NICU admission | neonatal admission to the NICU after delivery | 1 week |
| 29909265 | Background | 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. |
| 30376814 | Background | 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. |
| 37012128 | Background | 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. |
| ID | Term |
|---|---|
| D002821 | Chorioamnionitis |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005322 | Fetal Membranes, Premature Rupture |
| D007744 | Obstetric Labor Complications |
| D010922 | Placenta Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided