Antibiotic treatment in patients with preterm premature rupture of membranes, less than 33 weeks Pregnancy and Childbirth
Conditions
Interventions
Participants are randomized using the Excel program and their national identification document into two groups. Group A is managed with biassociated antibiotics: (first 48 hours) ampicillin 1 g every
Sponsors
Hospital Padre Hurtado
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women between 24+0 and 32+6 weeks 2. Diagnosis of premature rupture of membranes 3. Negative admission amniocentesis for intra-amniotic infection
Exclusion criteria
Exclusion criteria: 1. Patients outside the gestational age range 2. Positive admission amniocentesis for intra-amniotic infection 3. Concomitant infectious process that requires antibiotics (e.g. COVID-19; pyelonephritis, bacterial pneumonia, tonsillitis or another that requires antibiotic use) 4. Patient with a history of recent use of antibiotics in the last 10 days 5. Patient allergic to any of the antibiotics proposed in the different schemes 6. Patient undergoing multiple pregnancy 7. Patients who do not wish to participate and therefore do not sign the informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Control amniocentesis after antibiotic treatment and comparison of infection parameters, such as glucose, cell count, GRAM test and cell culture, at 14 days after the start of antibiotic treatment (10 days of antibiotics and 72 hours after the end, the new amniotic fluid analysis will be performed). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The latency period (the period that elapses from diagnosis to delivery): comparison between the date of initiation of antibiotic therapy and the date of birth on the birth certificate 2. The need for respiratory support in the newborn (NB) recorded in clinical records in the first 30 days of life 3. The prevalence of premature abruption of the placenta with normal insertion: clinical diagnosis recorded in the clinical record by the obstetrician or midwife who attends the delivery or caesarean section in the first 6 hours postpartum 4. The prevalence of neonatal necrotizing enterocolitis during the first 30 days of life, through clinical-radiological diagnosis 5. The prevalence of neonatal sepsis during the first 30 days of life, by clinical diagnosis made by a neonatologist using the Kaiser Permanente research classification"Neonatal Early-Onset Sepsis Calculator 6. The hospital stay in the neonatal intensive care unit during the first 30 days of life, through clinical records 7. The prevalence of clinical choriamyonitis diagnosed using Gibbs criteria from the start of antibiotic treatment until delivery 8. Maternal mortality from the moment of diagnosis until 42 days postpartum, evaluated by death certificate 9. Neonatal mortality from the moment of diagnosis until 28 days of life, evaluated by death certificate 10. The prevalence of puerperal endometritis using clinical diagnosis for the first 30 days after delivery 11. The reason for terminating the pregnancy (scheduled interruption of pregnancy vs emergency due to an added diagnosis, determined by evaluating clinical records) | — |
Countries
Chile
Contacts
Public ContactRodrigo Benitez
Outcome results
None listed