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PI has decided to end study due to changes in Texas law and no participants were enrolled
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The purpose of this study is to see if the use of prophylactic antibiotics in the expectant management of PPROM less than 22 weeks significantly reduce the rate of delivery within 7 days and to see if the use of prophylactic antibiotics in the expectant management of PPROM between 20 and 22 weeks decrease composite neonatal morbidity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of antibiotics prophylactically at the time of membrane rupture | Experimental | Membrane rupture per inclusion criteria will be less than 22 weeks |
|
| Administration of antibiotics non-prophylactically at 22 weeks | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of antibiotics prophylactically at the time of membrane rupture | Drug | Participants will receive the antibiotic regimen:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that delivered their babies after membrane rupture | from baseline to day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Latency, defined as the duration between rupture of membranes and delivery | from rupture of membranes to delivery(about 1-126 days after baseline) | |
| Number of participants that have Chorioamnionitis | Baseline upto delivery (about 1-126 days after baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khalil Chahine, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
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|
| Administration of antibiotics non-prophylactically at 22 weeks | Drug | Participants will receive latency antibiotics starting 22 weeks 0 days:
|
|
| Number of participants that develop sepsis | From baseline upto discharge (about 1-4 days post delivery) |
| Number of maternal deaths | From baseline upto discharge (about 1-4 days post delivery) |
| Number of admissions to intensive care unit (ICU) | From baseline upto discharge (about 1-4 days post delivery) |
| Number of participants that develop postpartum hemorrhage | postpartum hemorrhage could occur during the following:
| From baseline upto discharge (about 1-4 days post delivery) |
| Number of participants that develop maternal postpartum infection | Infection is defined as one of the following:
| within 6 weeks of delivery |
| Number of participants that develop maternal venous thromboembolism | within 6 weeks of delivery |