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The aims of this study are to determine whether antibiotics administered routinely in women presenting with premature rupture of membranes later than the 37+0 weeks of gestation can alter the rate of maternal and neonatal infection and to compare these rates between prompt (< 12 hour) and delayed (≥ 12 hour) induction in the group of patients not submitted to antibiotic prophylaxis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic group | Active Comparator | women submitted to antibiotic prophylaxis |
|
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ampicillin + gentamicin | Drug | ampicillin 1 g every six hours and gentamicin 240 mg every day intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| neonatal infection rate | neonatal infection rate includes early onset sepsis, meningitis and pneumonia | participants will be followed for the duration of hospital stay, an expected average of 3 days |
| maternal infection rate | maternal infection rate includes chorioamnionitis or puerperal endometritis | participants will be followed for the duration of hospital stay, an expected average of 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| comparison of the infection rates between prompt and delayed induction | rate of maternal and neonatal infection between prompt (<12h) and delayed induction (≥12h) in the group of patients not submitted to antibiotic prophylaxis | participants will be followed for the duration of hospital stay, an expected average of 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Filipa Faria Vaz Passos, Dr | Santa Maria Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Santa Maria | Lisbon | 1649-035 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23090521 | Derived | Passos F, Cardoso K, Coelho AM, Graca A, Clode N, Mendes da Graca L. Antibiotic prophylaxis in premature rupture of membranes at term: a randomized controlled trial. Obstet Gynecol. 2012 Nov;120(5):1045-51. doi: 10.1097/aog.0b013e31826e46bc. |
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| ID | Term |
|---|---|
| D002821 | Chorioamnionitis |
| D000071074 | Neonatal Sepsis |
| D005322 | Fetal Membranes, Premature Rupture |
| D004716 | Endometritis |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
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| D007744 | Obstetric Labor Complications |
| D010922 | Placenta Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000292 | Pelvic Inflammatory Disease |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D014591 | Uterine Diseases |
| D000091662 | Genital Diseases |
| Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |