Clinical trial NCT05469984: Comparing Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor
Official title: Comparing Obstetrical Outcomes and Infectious Morbidity Between Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Preterm Labor With Preterm Delivery
Premature Rupture of Membranes Prolonged
Keywords: prolonged term PROM
pre-term labor
prophylactic antibiotic
peripartum infection
bacterial distribution
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2022-07-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: women with prolonged premature rupture of membrane\>18 h or women in preterm delivery will be randomized to receive one of two prophylactic antibiotic treatment
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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

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

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Exclusion Criteria:

* 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

Primary outcomes:
measure: endometritis rate
timeFrame: up to 6 weeks postpartum
measure: chorioamnionitis rate
timeFrame: during labor (up to delivery of the newborn)
Secondary outcomes:
measure: cord blood pH
timeFrame: immediately after delivery of the placenta
measure: maternal intrapartum fever
timeFrame: during labor (up to delivery of the newborn)
measure: NICU (neonatal intensive care unit) hospitalization length,
timeFrame: up to 3 month from delivery
measure: rate of neonatal early onset sepsis
timeFrame: up to one week from delivery
measure: neonatal APGAR score
timeFrame: at 1 and 5 minute post-delivery
measure: Rate of participants treated with antibiotics during the postpartum period
timeFrame: 6 week postpartum
measure: maternal postpartum hospitalization length
timeFrame: up to 6 weeks post partum
measure: Number of neonate with ventilation support
timeFrame: one week from delivery
measure: Number of neonate treated with antibiotics
timeFrame: one week from delivery
Other outcomes:
Locations:
Study officials:
References:
citation: Apantaku O, Mulik V. Maternal intra-partum fever. J Obstet Gynaecol. 2007 Jan;27(1):12-5. doi: 10.1080/01443610601016644.
citation: Committee Opinion No. 712: Intrapartum Management of Intraamniotic Infection. Obstet Gynecol. 2017 Aug;130(2):e95-e101. doi: 10.1097/AOG.0000000000002236.
citation: 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, analysis, and presentation of immunization safety data. Vaccine. 2019 Dec 10;37(52):7610-7622. doi: 10.1016/j.vaccine.2019.05.030. No abstract available.
citation: 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.
citation: 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.