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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Preterm Labor With Preterm Delivery, Premature Rupture of Membranes Prolonged

Intervention / Treatment
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* Drug: Ampicillin Only Product
* Drug: ampicillin plus gentamicin


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: women with term prolonged>18h rupture of membrane<br>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<br>* women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin<br>Drug: ampicillin plus gentamicin<br>* women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin<br>|
| Active Comparator: women with preterm labor<br>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<br>* women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin<br>Drug: ampicillin plus gentamicin<br>* women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endometritis rate |  | up to 6 weeks postpartum | 
| chorioamnionitis rate |  | during labor (up to delivery of the newborn) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cord blood pH |  | immediately after delivery of the placenta | 
| maternal intrapartum fever | body temperature, | during labor (up to delivery of the newborn) | 
| NICU (neonatal intensive care unit) hospitalization length, | days | up to 3 month from delivery | 
| rate of neonatal early onset sepsis | positive blood culture | up to one week from delivery | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prolonged term PROM, pre-term labor, prophylactic antibiotic, peripartum infection, bacterial distribution