Premature Rupture of Membranes Prolonged, Preterm Labor With Preterm Delivery
Conditions
Keywords
prolonged term PROM, pre-term labor, prophylactic antibiotic, peripartum infection, bacterial distribution
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
Interventions
DRUGAmpicillin Only Product
women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin
DRUGampicillin plus gentamicin
women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin
Sponsors
Western Galilee Hospital-Nahariya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| endometritis rate | up to 6 weeks postpartum |
| chorioamnionitis rate | during labor (up to delivery of the newborn) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Rate of participants treated with antibiotics during the postpartum period | 6 week postpartum | — |
| cord blood pH | immediately after delivery of the placenta | — |
| Number of neonate with ventilation support | one week from delivery | — |
| Number of neonate treated with antibiotics | one week from delivery | — |
| maternal postpartum hospitalization length | up to 6 weeks post partum | — |
| maternal intrapartum fever | during labor (up to delivery of the newborn) | body temperature, |
Countries
Israel
Contacts
Primary ContactMaya Wolf, MD
Outcome results
None listed