Perinatal Outcomes, Preterm Premature Rupture of Membranes (PPROM), Prophylaxis
Conditions
Keywords
Preterm premature rupture of membranes, prophylaxis, perinatal outcomes
Brief summary
To investigate the effects of different antibiotic regimens used in preterm premature rupture of membranes (PPROM) on maternal and fetal outcomes after 34 weeks of gestation.
Detailed description
Background: To investigate the effects of different antibiotic regimens used in preterm premature rupture of membranes (PPROM) on maternal and fetal outcomes after 34 weeks of gestation. Methods: A total of 40 pregnant women diagnosed with PPROM after the 34th week of gestation were included in the study and randomly divided into two equal groups. Group-1: Sulbactam + ampicillin, azithromycin, and amoxicillin. Group-2: Ceftriaxone, clarithromycin, and amoxicillin. For all cases, obstetric history, time of delivery, latency period, infection markers, neonatal birth weight, APGAR scores, NICU requirement and length of stay, type of delivery and maternal complications were recorded.
Interventions
DRUGAntibiotic regimen 1: sulbactam + ampicillin + azithromycin
For the first 48 hours, 4×2 g IV sulbactam + ampicillin, 1 g oral azithromycin on day 1, and from days 3-7, 3×500 mg oral amoxicillin
DRUGAntibiotic regimen 2: ceftriaxone + clarithromycin + amoxicillin
For the first 48 hours, 1×1 g IV ceftriaxone + 2×500 mg oral clarithromycin, and from day 3 onwards, 3×500 mg oral amoxicillin + 2×500 mg oral clarithromycin.
Sponsors
Yuzuncu Yil University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Singleton pregnancies, * PPROM after 34 weeks of gestation
Exclusion criteria
* Patients with fetal anomalies * Preeclampsia, gestational or pregestational diabetes mellitus, * Multiple pregnancies, * Chorioamnionitis, placental abruption, cord prolapse, fetal distress, or other complicated pregnancies. * Maternal immunodeficiency * The presence of other infections requiring antibiotic therapy, antenatal corticosteroid use, chronic diseases, * Unwillingness to participate and sign the detailed informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| neonatal birth weight | From enrollment to the end of treatment at 4 weeks | neonatal birth weight |
| mode of birth checklist | From enrollment to the end of treatment at 4 weeks | Effect of different antibiotic regimens on fetal and maternal outcomes: mode of birth checklist |
| 1st and 5th minute APGAR scores | From enrollment to the end of treatment at 4 weeks | 1st and 5th minute APGAR scores |
| need for NICU (neonatal intensive care unit) admission | From enrollment to the end of treatment at 4 weeks | need for NICU (neonatal intensive care unit) admission |
| duration of NICU stay | From enrollment to the end of treatment at 4 weeks | duration of NICU stay. |
| White blood cell (WBC) count | From enrollment to the end of treatment at 4 weeks | White blood cell (WBC) count was measured every 48 hours |
| C-reactive protein (CRP) levels | From enrollment to the end of treatment at 4 weeks | C-reactive protein (CRP) level was measured every 48 hours |
| Maternal complications | From enrollment to the end of treatment at 4 weeks | Maternal complications; chorioamnionitis, placental abruption |
Countries
Turkey (Türkiye)
Outcome results
None listed