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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic regimen 1 | Active Comparator |
| |
| Antibiotic regimen 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic regimen 1: sulbactam + ampicillin + azithromycin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| mode of birth checklist | Effect of different antibiotic regimens on fetal and maternal outcomes: mode of birth checklist | From enrollment to the end of treatment at 4 weeks" |
| neonatal birth weight | neonatal birth weight | From enrollment to the end of treatment at 4 weeks" |
| 1st and 5th minute APGAR scores | 1st and 5th minute APGAR scores | From enrollment to the end of treatment at 4 weeks" |
| need for NICU (neonatal intensive care unit) admission | need for NICU (neonatal intensive care unit) admission | From enrollment to the end of treatment at 4 weeks" |
| duration of NICU stay | duration of NICU stay. | From enrollment to the end of treatment at 4 weeks" |
| White blood cell (WBC) count | White blood cell (WBC) count was measured every 48 hours | From enrollment to the end of treatment at 4 weeks" |
| C-reactive protein (CRP) levels | C-reactive protein (CRP) level was measured every 48 hours | From enrollment to the end of treatment at 4 weeks" |
| Maternal complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Van Yuzuncu Yil University | Van | 65100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26441216 | Result | Lee J, Romero R, Kim SM, Chaemsaithong P, Yoon BH. A new antibiotic regimen treats and prevents intra-amniotic inflammation/infection in patients with preterm PROM. J Matern Fetal Neonatal Med. 2016 Sep;29(17):2727-37. doi: 10.3109/14767058.2015.1103729. Epub 2015 Dec 2. | |
| 36791845 | Result | Sgayer I, Francis YN, Miron D, Shprits E, Sheffer VF, Rechnitzer H, Lowenstein L, Wolf MF. Compared perinatal outcomes of two prophylactic antibiotic regimens for preterm premature rupture of membranes: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 May;5(5):100900. doi: 10.1016/j.ajogmf.2023.100900. Epub 2023 Feb 13. |
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Randomized Controlled Trial
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| Antibiotic regimen 2: ceftriaxone + clarithromycin + amoxicillin | Drug | 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. |
|
Maternal complications; chorioamnionitis, placental abruption
| From enrollment to the end of treatment at 4 weeks" |
| ID | Term |
|---|---|
| C563032 | Preterm Premature Rupture of the Membranes |
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| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D017963 | Azithromycin |
| D017291 | Clarithromycin |
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
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