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| Name | Class |
|---|---|
| Bronx Care Health System | OTHER |
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This is a randomized controlled trial examining whether the use of misoprostol or pitocin, in combination with a foley catheter, is more effective at inducing labor in patients with a gravid BMI that is considered obese.
This randomized controlled trial will include patients with a BMI greater than 30 at the time of admission for their induction of labor. Patients will be randomized to either misoprostol or Pitocin to begin induction of labor, alongside the standard foley catheter, and the primary outcome of interest will be length of time from start of induction until delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol and Pitocin | Active Comparator | Patient receives misoprostol and foley catheter for initial induction of labor, followed by pitocin later on. |
|
| Pitocin only | Active Comparator | Patient receives pitocin and foley catheter for initial induction of labor, followed by more pitocin later on. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | 25 mcg vaginally every 6 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from induction to delivery | Simple measure calculating time from start of induction until delivery of neonate. | start of induction until delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Delivery outcome | Simple determination whether patient had a vaginal delivery or delivered by cesarean section. | at delivery |
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Inclusion Criteria:
- Pregnant patient presenting to labor & delivery for induction of labor with a BMI > = 30
Exclusion Criteria:
- Pregnant patient presenting to labor & delivery for induction of labor with BMI < 30
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| Name | Affiliation | Role |
|---|---|---|
| Nicola F Tavella, MPH | Icahn School of Medicine at Mount Sinai | Study Director |
| Angela Bianco, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | New York | New York | 10029 | United States | ||
| Bronx Care Health System |
All of the individual participant data collected during the trial, after deidentification.
Beginning 3 months and ending 5 years following article publication.
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.
To achieve aims in the approved proposal. Proposals should be directed to Nicola.tavella@mssm.edu. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D045730 | Soy Foods |
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Pitocin | Drug | 3-6 mL intravenously every hour |
|
| The Bronx |
| New York |
| 10457 |
| United States |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D000074421 | Fermented Foods |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
| D005502 | Food |
| D019602 | Food and Beverages |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |