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This study will compare the effectiveness of vaginal misoprostol (Cytotec) and intravenous oxytocin (Pitocin) in multiparous women who present at term for labor induction.
Both oxytocin and misoprostol have been demonstrated to be safe and effective methods for induction of labor. A direct comparison of efficacy and time to delivery in multiparas has not been specifically investigated. Additionally, the study will look at costs of the two drugs.Oxytocin is administered through an IV so requires more direct patient care time from the Registered Nurse, IV pump, and tubing, whereas misoprostol is a tablet, administered only once, per vagina or orally, every 4 hours. Misoprostol is also very inexpensive comparatively; if equally or more efficacious than oxytocin, this could demonstrate quite a cost and time savings to Vanderbilt University Medical Center and other institutions. Safety of either drug is not in question.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal Misoprostol | Active Comparator | Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal |
|
| Intravenous Oxytocin | Active Comparator | 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal Misoprostol | Drug | Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Induction to Vaginal Delivery | Comparing the time to delivery in multiparas undergoing induction of labor with vaginal misoprostol or intravenous oxytocin. | Time to delivery in minutes from initiation of medication, up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal APGAR Scores | APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. | At 1 minute and 5 minutes after delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Wilson-Liverman, MSN, CNM | Vanderbilt University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21676083 | Background | Chaudhuri S, Mitra SN, Banerjee PK, Biswas PK, Bhattacharyya S. Comparison of vaginal misoprostol tablets and prostaglandin E2 gel for the induction of labor in premature rupture of membranes at term: a randomized comparative trial. J Obstet Gynaecol Res. 2011 Nov;37(11):1564-71. doi: 10.1111/j.1447-0756.2011.01575.x. Epub 2011 Jun 16. | |
| 21506657 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vaginal Misoprostol | Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal |
| FG001 | Intravenous Oxytocin | 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vaginal Misoprostol | Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Time From Induction to Vaginal Delivery | Comparing the time to delivery in multiparas undergoing induction of labor with vaginal misoprostol or intravenous oxytocin. | Posted | Median | Inter-Quartile Range | minutes | Time to delivery in minutes from initiation of medication, up to 24 hours |
|
13 months
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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 | Vaginal Misoprostol | Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Wilson-Liverman CNM | Vanderbilt University Medical Center | angela.wilson-liverman@vanderbilt.edu |
| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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|
| Intravenous Oxytocin | Drug | Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous |
|
|
| Neonatal Weight at Delivery | Neonatal Weight | Immediately following delivery |
| Maternal Delivery Outcomes | Maternal delivery outcomes | Through discharge from hospital |
| Maternal Satisfaction With Labor | 6 weeks post-partum |
| Number of Participants With Excessive Uterine Activity Necessitating Treatment | Number of patients receiving terbutaline during labor for uterine tachysytole | Measured from initiation of medication until delivery time |
| NICU Admission and APGAR Less Than 7 at 5 Minutes | NICU admission and APGAR less than 7 at 5 minutes | Through discharge from hospital |
| Olagbuji BN, Ezeanochie MC, Kubeyinje W, Dunsin T, Ande AB. Pregnancy outcome following induction of labor with intravaginal misoprostol for decreased fetal movements at term. J Matern Fetal Neonatal Med. 2011 Oct;24(10):1225-7. doi: 10.3109/14767058.2011.572309. Epub 2011 Apr 20. |
| 21482368 | Background | Saeed GA, Fakhar S, Nisar N, Alam AY. Misoprostol for term labor induction: a randomized controlled trial. Taiwan J Obstet Gynecol. 2011 Mar;50(1):15-9. doi: 10.1016/j.tjog.2009.08.001. |
| 21180218 | Background | Shakya R, Shrestha J, Thapa P. Safety and efficacy of misoprostol and dinoprostone as cervical ripening agents. JNMA J Nepal Med Assoc. 2010 Jan-Mar;49(177):33-7. |
| 20927722 | Background | Hofmeyr GJ, Gulmezoglu AM, Pileggi C. Vaginal misoprostol for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD000941. doi: 10.1002/14651858.CD000941.pub2. |
| 17081181 | Background | Crane JM, Butler B, Young DC, Hannah ME. Misoprostol compared with prostaglandin E2 for labour induction in women at term with intact membranes and unfavourable cervix: a systematic review. BJOG. 2006 Dec;113(12):1366-76. doi: 10.1111/j.1471-0528.2006.01111.x. |
| 16135593 | Background | Lin MG, Nuthalapaty FS, Carver AR, Case AS, Ramsey PS. Misoprostol for labor induction in women with term premature rupture of membranes: a meta-analysis. Obstet Gynecol. 2005 Sep;106(3):593-601. doi: 10.1097/01.AOG.0000172425.56840.57. |
| 15043790 | Background | Li XM, Wan J, Xu CF, Zhang Y, Fang L, Shi ZJ, Li K. Misoprostol in labour induction of term pregnancy: a meta-analysis. Chin Med J (Engl). 2004 Mar;117(3):449-52. |
| BG001 |
| Intravenous Oxytocin |
2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous
Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous
|
|
|
| Secondary | Neonatal APGAR Scores | APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. | Posted | Median | Inter-Quartile Range | number | At 1 minute and 5 minutes after delivery |
|
|
|
| Secondary | Neonatal Weight at Delivery | Neonatal Weight | Posted | Median | Inter-Quartile Range | grams | Immediately following delivery |
|
|
|
| Secondary | Maternal Delivery Outcomes | Maternal delivery outcomes | Posted | Count of Participants | Participants | Through discharge from hospital |
|
|
|
| Secondary | Maternal Satisfaction With Labor | data was not collected | Posted | 6 weeks post-partum |
|
|
| Secondary | Number of Participants With Excessive Uterine Activity Necessitating Treatment | Number of patients receiving terbutaline during labor for uterine tachysytole | Posted | Count of Participants | Participants | Measured from initiation of medication until delivery time |
|
|
|
| Secondary | NICU Admission and APGAR Less Than 7 at 5 Minutes | NICU admission and APGAR less than 7 at 5 minutes | Posted | Count of Participants | Participants | Through discharge from hospital |
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | Intravenous Oxytocin | 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous | 0 | 59 | 0 | 59 | 0 | 59 |
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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 |
| Chorioamnionitis |
|
| Cesarean delivery |
|
| Forceps delivery |
|