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Though cervical insufficiency is a common cause of second trimester pregnancy loss, the placement of an emergent cerclage in these patients is thought to improve perinatal outcomes. It is unknown whether the use of tocolytics and antibiotics prolongs pregnancies complicated by need for emergent cerclage.
The objective is to determine whether administration of peri-operative antibiotics and indomethacin to patients receiving emergent cerclages for cervical insufficiency increases latency period to delivery compared with patients receiving emergent cerclage alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | emergent cerclage with no peri-operative antibiotics or indomethacin | |
| indomethacin and antibiotics | Experimental | perioperative antibiotics and indomethacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indomethacin and antibiotics (cefazolin or clindamycin) | Drug | q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gestational Latency Achieved Between Cerclage Placement and Time of Delivery | Median gestational latency achieved Between Cerclage Placement and Time of Delivery | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational Latency of More Than 28 Days | The frequency of achieving a gestational latency of more than 28 days | 28 days postpartum |
| Gestational Age at Delivery | Median gestational age at delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prentice Women's Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24807330 | Result | Miller ES, Grobman WA, Fonseca L, Robinson BK. Indomethacin and antibiotics in examination-indicated cerclage: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1311-1316. doi: 10.1097/AOG.0000000000000228. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | emergent cerclage with no peri-operative antibiotics or indomethacin |
| FG001 | Indomethacin and Antibiotics | perioperative antibiotics and indomethacin Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | emergent cerclage with no peri-operative antibiotics or indomethacin |
| BG001 | Indomethacin and Antibiotics | perioperative antibiotics and indomethacin Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gestational Latency Achieved Between Cerclage Placement and Time of Delivery | Median gestational latency achieved Between Cerclage Placement and Time of Delivery | Posted | Median | Inter-Quartile Range | days | 24 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | emergent cerclage with no peri-operative antibiotics or indomethacin |
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Because this study was not adequately powered to detect differences in perinatal outcomes, whether this adjunctive therapy affects these outcomes remains uncertain.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emily Miller | Northwestern University Feinberg School of Medicine | 3124724685 | emily-miller-1@northwestern.edu |
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| ID | Term |
|---|---|
| D002581 | Uterine Cervical Incompetence |
| ID | Term |
|---|---|
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D000900 | Anti-Bacterial Agents |
| D002437 | Cefazolin |
| D002981 | Clindamycin |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| 24 weeks |
| Neonatal Morbidity and Mortality | Days spent in the neonatal intensive care unit | 1 year |
| Birthweight | Median birthweight | 24 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Gestational Latency of More Than 28 Days | The frequency of achieving a gestational latency of more than 28 days | Posted | Number | percentage of participants | 28 days postpartum |
|
|
|
|
| Secondary | Gestational Age at Delivery | Median gestational age at delivery | Posted | Median | Inter-Quartile Range | weeks | 24 weeks |
|
|
|
|
| Secondary | Neonatal Morbidity and Mortality | Days spent in the neonatal intensive care unit | Posted | Median | Inter-Quartile Range | days | 1 year |
|
|
|
| Secondary | Birthweight | Median birthweight | Posted | Median | Inter-Quartile Range | grams | 24 weeks |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Indomethacin and Antibiotics | perioperative antibiotics and indomethacin Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin | 0 | 26 | 0 | 26 |
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000026 | Abortion, Habitual |
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D000091662 | Genital Diseases |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |