Comparing Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: women with term prolonged>18h rupture of membrane women with term prolonged >18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery |
Drug: Ampicillin Only Product
women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin
Drug: ampicillin plus gentamicin
women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin
|
| Active Comparator: women with preterm labor women with term prolonged >18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery plus IV gentamicin 5 mg/kg every 24 hours |
Drug: Ampicillin Only Product
women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin
Drug: ampicillin plus gentamicin
women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin
|
Outcome Measures
Primary Outcome Measures
- endometritis rate [up to 6 weeks postpartum]
- chorioamnionitis rate [during labor (up to delivery of the newborn)]
Secondary Outcome Measures
- cord blood pH [immediately after delivery of the placenta]
- maternal intrapartum fever [during labor (up to delivery of the newborn)]
body temperature,
- NICU (neonatal intensive care unit) hospitalization length, [up to 3 month from delivery]
days
- rate of neonatal early onset sepsis [up to one week from delivery]
positive blood culture
- neonatal APGAR score [at 1 and 5 minute post-delivery]
- Rate of participants treated with antibiotics during the postpartum period [6 week postpartum]
- maternal postpartum hospitalization length [up to 6 weeks post partum]
- Number of neonate with ventilation support [one week from delivery]
- Number of neonate treated with antibiotics [one week from delivery]
Eligibility Criteria
Criteria
Inclusion Criteria: maternal age > 18 years singleton pregnancy vertex presentation prolonged >18 h prom or preterm delivery
-
Exclusion Criteria:
-
GBS carrier
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preterm premature rupture of membrane for conservative treatment
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intra-uterine fetal death fetal major anomaly
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drug allergy for the antibiotic in use in this study
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women receiving antibiotic treatment for other infection such as urinary tract infection
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Western Galilee Hospital-Nahariya
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Apantaku O, Mulik V. Maternal intra-partum fever. J Obstet Gynaecol. 2007 Jan;27(1):12-5. Review.
- Committee Opinion No. 712: Intrapartum Management of Intraamniotic Infection. Obstet Gynecol. 2017 Aug;130(2):e95-e101. doi: 10.1097/AOG.0000000000002236.
- Kachikis A, Eckert LO, Walker C, Bardají 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. Review.
- 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.
- 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.
- 0103-22-NHR