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Cervical insufficiency is defined as painless cervical dilation in the second trimester. Cervical insufficiency can ultimately lead to second trimester loss of pregnancy. Cerclages are utilized in pregnancies affected by cervical insufficiency in order to prolong gestational latency. There have been several studies investigating the efficacy of perioperative medications for cerclage placement and the effects they have on gestational latency. Some such studies have found that perioperative indomethacin in combination with antibiotics have significantly increased gestational latency when compared to placebo. Indomethacin has traditionally been the tocolytic of choice with cerclage placement. At our hospital, ibuprofen has been the tocolytic of choice for cerclage placement secondary to pharmacy availability. Our study aims to evaluate whether gestational latency differs among patients undergoing emergent cerclage whether they receive perioperative ibuprofen or indomethacin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen | Active Comparator | Ibuprofen 600 mg q6 hours for 24 hours- total dose of 2400mg- after emergent cerclage placement |
|
| Indomethacin | Active Comparator | Indomethacin 50 mg q8 hours for 24 hours- total dose of 150mg- after emergent cerclage placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indomethacin 150mg | Drug | Patients will be randomized to either received perioperative indomethacin or ibuprofen at the time of their emergent cerclage placement for 24 hours following surgery. Patient will be followed up through our electronic medical record system to determine gestational latency to evaluate if ibuprofen is inferior to indomethacin. |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational latency | Days from cerclage placement to delivery, assessed up to 26 weeks | From cerclage placement to delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Preterm birth | Birth before 37 weeks gestation | At delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Simmons, DO | Woman's Hospital, Louisiana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woman's Hospital | Baton Rouge | Louisiana | 70817 | United States |
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| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Ibuprofen 2400mg | Drug | Patients will be randomized to either received perioperative indomethacin or ibuprofen at the time of their emergent cerclage placement for 24 hours following surgery. Patient will be followed up through our electronic medical record system to determine gestational latency to evaluate if ibuprofen is inferior to indomethacin. |
|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |