Comparing Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor

Официальное название

Comparing Obstetrical Outcomes and Infectious Morbidity Between Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor

Обзор

This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity

Подробное описание

Maternal peripartum fever is a common complication of pregnancy and postpartum period associated with potentially serious obstetrical outcomes and infectious morbidity. Peripartum infections includes intrapartum intraamniotic infection (IAI) and postpartum endometritis. Both are caused by polymicrobial bacterial infection. Increased latency period from rupture of membranes (ROM) until delivery is a common risk factor. Another risk factor is pre-term delivery.

This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity.

Primary outcome-peripartum infections- chorioamnionitis, endometritis and surgical site infection secondary outcome- obstetrical outcome- mode of delivery, Apgar score, cord blood pH, peripartum fever, maternal length of admission, postpartum maternal antibiotic treatment, Surface swab cultures were obtained from the placenta, amnion and umbilical cord (birth cultures) and uterine swab cultures, maternal blood culture, placental histologic evaluation neonatal outcomes-NICU admission, length of admission, neonatal morbidity-ventilation support, early neonatal sepsis

Вмешательства

• Препарат Ampicillin Only Product
  women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin
• Препарат ampicillin plus gentamicin
  women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin

Первичные конечные точки

• endometritis rate [Срок оценки: up to 6 weeks postpartum]
• chorioamnionitis rate [Срок оценки: during labor (up to delivery of the newborn)]

Вторичные конечные точки (8)

• cord blood pH [Срок оценки: immediately after delivery of the placenta]
• maternal intrapartum fever [Срок оценки: during labor (up to delivery of the newborn)]
• NICU (neonatal intensive care unit) hospitalization length, [Срок оценки: up to 3 month from delivery]
• rate of neonatal early onset sepsis [Срок оценки: up to one week from delivery]
• Rate of participants treated with antibiotics during the postpartum period [Срок оценки: 6 week postpartum]
• maternal postpartum hospitalization length [Срок оценки: up to 6 weeks post partum]
• Number of neonate with ventilation support [Срок оценки: one week from delivery]
• Number of neonate treated with antibiotics [Срок оценки: one week from delivery]

Критерии участия

Inclusion Criteria: maternal age > 18 years singleton pregnancy vertex presentation prolonged >18 h prom or preterm delivery

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Критерии исключения

• GBS carrier
• preterm premature rupture of membrane for conservative treatment
• intra-uterine fetal death fetal major anomaly
• drug allergy for the antibiotic in use in this study
• women receiving antibiotic treatment for other infection such as urinary tract infection

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Израиль · 1 центр

• Galil Medical Center — Nahariya

Публикации

• Apantaku O, Mulik V. Maternal intra-partum fever. J Obstet Gynaecol. 2007 Jan;27(1):12-5. doi: 10.1080/01443610601016644. PMID 17365450
• Committee Opinion No. 712: Intrapartum Management of Intraamniotic Infection. Obstet Gynecol. 2017 Aug;130(2):e95-e101. doi: 10.1097/AOG.0000000000002236. PMID 28742677
• Kachikis A, Eckert LO, Walker C, Bardaji A, Varricchio F, Lipkind HS, Diouf K, Huang WT, Mataya R, Bittaye M, Cutland C, Boghossian NS, Mallett Moore T, McCall R, King J, Mundle S, Munoz FM, Rouse C, Gravett M, Katikaneni L, Ault K, Klein NP, Roberts DJ, Kochhar S, Chescheir N; Brighton Collaboration Chorioamnionitis Working Group. Chorioamnionitis: Case definition & guidelines for data collection PMID 31783982
• Yoon BH, Romero R, Moon JB, Shim SS, Kim M, Kim G, Jun JK. Clinical significance of intra-amniotic inflammation in patients with preterm labor and intact membranes. Am J Obstet Gynecol. 2001 Nov;185(5):1130-6. doi: 10.1067/mob.2001.117680. PMID 11717646
• Soper DE, Mayhall CG, Froggatt JW. Characterization and control of intraamniotic infection in an urban teaching hospital. Am J Obstet Gynecol. 1996 Aug;175(2):304-9; discussion 309-10. doi: 10.1016/s0002-9378(96)70139-4. PMID 8765246

Идентификаторы

NCT: NCT05469984 · 0103-22-NHR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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