Maternal Infection During Pregnancy (Diagnosis), Neonatal Infection
Conditions
Keywords
term premature rupture of membranes, antibiotic prophylaxis, chorioamnionitis, endometritis, neonatal infection
Brief summary
The primary aim of this study is to determine if antibiotics combined with immediate induction can significantly reduce the rate of maternal and neonatal infection compared with immediate induction alone in women presenting with PROM later than the 37+0 weeks of gestation. The secondary aim is to compare the rates of infection between immediate and delayed induction in women submitted to antibiotic prophylaxis.
Detailed description
In a randomized controlled non-blind trial, low-risk women with singleton term pregnancies and a negative Group B Streptococcus culture presenting with PROM are randomly assigned to group A (immediate induction with antibiotic prophylaxis), group B (immediate induction without antibiotic prophylaxis) or group C (delayed induction with antibiotic prophylaxis).
Interventions
DRUGCefoxitin
DRUGoxytocin/misoprostol
Sponsors
Hospital de Santa Maria, Portugal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* term (≥ 37+0 weeks) singleton pregnancy, a vertex presentation, ruptured membranes for less than 12 hours and a negative Group B Streptococcus (GBS) culture performed between 35 and 37 weeks.
Exclusion criteria
* active labor, absence of GBS culture or indication for GBS antibiotic prophylaxis, contraindication to expectant management or to vaginal delivery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal and neonatal infection rate | intrapartum and immediate postpartum |
Countries
Portugal
Contacts
Primary ContactFilipa FV Passos, MD
Backup ContactRita Silva, MD
Outcome results
None listed