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This is a prospective, randomized, controlled trial designed to examine the efficacy of oral misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin augmentation | Active Comparator | Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin. |
|
| Misoprostol augmentation | Active Comparator | Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | 75 micrograms orally every 4 hours for up to 2 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uterine Tachysystole | Defined as six contractions in two consecutive 10-minute periods | Up to four hours after administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Apgar Score <4 | Assigned on a scale of 0-10 by pediatric provider attending delivery. A lower score reflects need for further resuscitation and is potentially associated with increased risk of adverse neurological outcomes. | 5 minutes after delivery |
| Umbilical Cord Artery pH <7.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| April Bleich, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Kenneth Leveno, MD | University of Texas Southwestern Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22105254 | Derived | Bleich AT, Villano KS, Lo JY, Alexander JM, McIntire DD, Leveno KJ. Oral misoprostol for labor augmentation: a randomized controlled trial. Obstet Gynecol. 2011 Dec;118(6):1255-1260. doi: 10.1097/AOG.0b013e318236df5b. |
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Women presenting to Labor and Delivery at Parkland Memorial Hosiptal and who met eligibility requirements were offered participation from Decemeber 2008 through January 2001.
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| ID | Title | Description |
|---|---|---|
| FG000 | Misoprostol Augmentation | Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol. Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses. |
| FG001 | Oxytocin Augmentation | Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin. Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized |
| |||||||||||||
| Received Study Drug |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Misoprostol Augmentation | Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol. Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses. |
| BG001 | Oxytocin Augmentation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Uterine Tachysystole | Defined as six contractions in two consecutive 10-minute periods | Intent to treat | Posted | Number | participants | Up to four hours after administration of study drug |
|
During study period
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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 | Misoprostol Augmentation | Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol. Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Need for emergent cesarean delivery secondary to nonreassuirng fetal heart rate | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. April Bleich | University of Texas Southwestern Medical Center | 214-648-2316 | april.bleich@gmail.com |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Oxytocin | Drug | Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital |
|
|
| Obtained at delivery |
| Admission of Neonatal Intensive Care Unit | Until hospital discharge |
| Maternal Chorioamnionitis | Temperature 38 degrees C or higher in the absence of other sources of infection | During labor |
| Maternal Hypovolemia Requiring Blood Transfusion | Until hospital discharge |
| Method of Delivery | At delivery |
| Time Elapsed From Start of Labor Augmentation to Delivery | Initiation of augmentation until delivery |
| NOT COMPLETED |
|
|
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin. Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Infant Apgar Score <4 | Assigned on a scale of 0-10 by pediatric provider attending delivery. A lower score reflects need for further resuscitation and is potentially associated with increased risk of adverse neurological outcomes. | Intent to treat | Posted | Number | infants | 5 minutes after delivery |
|
|
|
| Secondary | Umbilical Cord Artery pH <7.1 | Intent to treat | Posted | Number | infants | Obtained at delivery |
|
|
|
| Secondary | Admission of Neonatal Intensive Care Unit | Intent to treat | Posted | Number | infants | Until hospital discharge |
|
|
|
| Secondary | Maternal Chorioamnionitis | Temperature 38 degrees C or higher in the absence of other sources of infection | Intent to treat | Posted | Number | participants | During labor |
|
|
|
| Secondary | Maternal Hypovolemia Requiring Blood Transfusion | Intent to treat | Posted | Number | participants | Until hospital discharge |
|
|
|
| Secondary | Method of Delivery | Intent to treat | Posted | Number | participants | At delivery |
|
|
|
| Secondary | Time Elapsed From Start of Labor Augmentation to Delivery | Intent to treat | Posted | Median | Inter-Quartile Range | minutes | Initiation of augmentation until delivery |
|
|
|
| 1 |
| 176 |
| 0 |
| 176 |
| EG001 | Oxytocin Augmentation | Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin. Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital | 2 | 174 | 0 | 174 |
|
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| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| 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 |
| Cesarean for dystocia |
|
| Cesarean for nonreassuring fetal heart rate |
|