Women with preterm premature rupture of membranes between 24-33+6 weeks of gestation requiring antibiotics for prolong latency period. Preterm premature rupture of membranes Preterm prelabor rupture of membranes Antibiotics to prolong latency period Early-onset neonatal sepsis Randomized controlled trial
Conditions
Interventions
Cefuroxime 750 mg, intravenous route every 8 hours for 48 hours then Cefuroxime 500 mg, oral route every 12 hours for 5 days plus with Azithromycin 500 mg oral in first day then Azithromycin 250 mg or
Active Comparator Drug,Active Comparator Drug
Cefuroxime plus Azithromycin,Ampicillin plus Azithromycin
Sponsors
Ratchasapisek Sompoch grant
Eligibility
Sex/Gender
Female
Age
15 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Women with singleton pregnancy between 24 - 33+6 weeks of gestational age. 2. Women with first episode of premature rupture of membrane 3. No evidence of intra-amniotic infection (chorioamnionitis)* 4. Reassuring fetus evaluated by nonstress test (NST) or biophysical profile (BPP)* * Subsequent discovery of an evidence of intraamniotic infection (chorioamnionitis) or non-reassuring fetus is not an exclusion.
Exclusion criteria
Exclusion criteria: 1. Women with preterm labor with spontaneous rupture of membrane 2. Immunocompromised status such as human immunodeficiency virus infection, over diabetes mellitus etc. 3. Women with an autoimmune disease such as systemic lupus erythematosus, rheumatoid arthritis and anti-phospholipid syndromes etc. 4. Women with known infection such as septicemia, pneumonia and pyelonephritis etc. 5. Women with already prescribed antibiotics within 7 days before the onset of preterm premature rupture of membrane. 6. History of Penicillin, Cephalosporin or Macrolide allergy. 7. Women with a contraindication for expectant management in case of preterm premature rupture of membrane such as intraamniotic infection, fetal non-reassuring. 8. Women with a fetal lethal anomaly * 9. History of obstetric operation or procedure in the current pregnancy such as cervical cerclage, fetal surgery) and Amniocentesis etc. 10. Women with abdominal trauma before the onset of preterm premature rupture of membrane. 11. Women with an active genital lesion such as genital herpes, herpes zoster, and Condyloma accuminata etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early onset neonatal sepsis 72 hours after birth Clinical assessment by pediatricians and neonatologists | — |
Secondary
| Measure | Time frame |
|---|---|
| Latency period at least 48 hours after onset of PPROM the onset of PPROM to the time of delivery,Chorioamnionitis (intraamniotic infection) Intrapartum period Triple I criteria,Postpartum maternal infection 6 weeks after delivery Clinical assessment by obstetricians,Intrapartum maternal fever Intrapartum period Triple I criteria,Neonatal respiratory distress 6 weeks after birth Clinical assessment by pediatricians and neonatologists,APGAR score at 5th minute 5 minutes after birth APGAR score | — |
Countries
Thailand
Contacts
Public ContactSirarat Ittipuripat
Faculty of Medicine, Chulalongkorn university
Outcome results
None listed