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The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.
Induction of labor is required in approximately 20% of pregnant women. Although contractions can be brought on by oxytocin ("pitocin"), some women need help in softening the cervix, or mouth of the womb (uterus), before oxytocin can be started. Prostaglandins have been shown to ripen, or soften, the cervix; at present, the only prostaglandin approved for marketing by FDA for this purpose is dinoprostone. Dinoprostone can be delivered in several ways; one method is to use a polymer vaginal insert that slowly releases the dinoprostone directly to the cervical tissues. This product is called Cervidil (R) and has been marketed for more than 10 years in the United States. Misoprostol is another form of prostaglandin that is approved for protecting the stomach and intestinal lining for patients taking NSAIDs. Misoprostol has also been used by many obstetricians for cervical ripening and inducing contractions, but, it is not approved by FDA for this purpose.
The same company that makes the Cervidil polymer insert has made an insert that will slowly release misoprostol. This study will determine whether this investigational insert containing misoprostol will decrease time to vaginal delivery compared to Cervidil. Two different doses of misoprostol will be tested (50 micrograms and 100 micrograms); each vaginal insert will gradually release a small, controlled amount of misoprostol over up to 24 hours.
Comparator: The Cervidil (R) vaginal insert containing dinoprostone will be the comparator in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MVI 100 | Experimental | Misoprostol vaginal insert 100 mcg over 24h |
|
| MVI 50 | Experimental | Misoprostol vaginal insert 50 mcg over 24h |
|
| Cervidil 10 mg vaginal insert | Active Comparator | Cervidil 10 mg over 24h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol vaginal insert 100 mcg | Drug | Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h. |
| Measure | Description | Time Frame |
|---|---|---|
| Minutes From Drug Insertion to Vaginal Delivery | Interval between time/date of insertion of study drug and time/date of neonate birth. This is a time-to-event analysis, there is no set time for the assessment. The endpoint occurs when the baby is born. 48 hours can be used as an approximate interval by which time most of the babies have been delivered. | 2880 minutes |
| Percentage of Participants With a Cesarean Section Delivery | Percentage of participants with cesarean delivery after study drug was administered. There is no set assessment time or date as the woman's labor may last hours or days. | 2880 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events | This outcome reports the percentage of adverse events in each treatment arm spontaneously reported or observed during the study. The intrapartum period (mother is still pregnant) is called the "Maternal/Fetal" period; once the baby has been born, adverse events are assessed separately for the mother (Post Partum) and the baby (Neonatal). The number of adverse events was assessed separately for each of the three periods. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen Colquhoun, MD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Medical Center | Birmingham | Alabama | 35249 | United States | ||
| Banner Desert Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16157114 | Background | Castaneda CS, Izquierdo Puente JC, Leon Ochoa RA, Plasse TF, Powers BL, Rayburn WF. Misoprostol dose selection in a controlled-release vaginal insert for induction of labor in nulliparous women. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 2):1071-5. doi: 10.1016/j.ajog.2005.06.072. | |
| 16443504 | Background | Rayburn WF, Powers BL, Plasse TF, Carr D, Di Spirito M. Pharmacokinetics of a controlled-release misoprostol vaginal insert at term. J Soc Gynecol Investig. 2006 Feb;13(2):112-7. doi: 10.1016/j.jsgi.2005.10.004. |
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First subject entered 26 April 2006; last subject completed 07 August 2007; 49 hospitals entered subjects requiring cervical ripening prior to induction of labor.
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| ID | Title | Description |
|---|---|---|
| FG000 | Misoprostol Vaginal Insert (MVI) 100 | Misoprostol vaginal insert 100 mcg over a period of up to 24 h |
| FG001 | Misoprostol Vaginal Insert (MVI) 50 | Misoprostol vaginal insert 50 mcg over a period of up to 24 h |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Misoprostol vaginal insert 50 mcg | Drug | Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h. |
|
|
| Dinoprostone vaginal insert (Cervidil) | Drug | Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h. |
|
|
| 96 hours |
| Percentage of Participants With Pre-Delivery Oxytocin Use | Incidence in each treatment group of need for oxytocin for pre-delivery induction or augmentation of labor. | 2880 minutes |
| Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert | Measured the percentage of participants who achieved success on the mBS. This composite score is based on the mBS and vaginal delivery and it is measured 12 hours after insertion of the study drug. The mBS has a score of 0 when the cervix is not ripe and a score of 12 when completely ripened. The 12 hour score is compared to baseline. Using the mBS, assess at 12 hours whether each subject has met any of the following three criteria: 1) has improved (increased) the mBS by at least 3 points from baseline; 2) has reached a score of at least 6 on the mBS; or 3) has acheived a vaginal delivery. | 12 hours |
| Minutes to Onset of Active Labor | Interval from insertion of study drug to onset of active labor, defined as at least three contractions in a ten-minute period of at least moderate intensity and resulting in cervical change such as dilatation or effacement; OR at least 4 cm cervical dilatation achieved after progressive change in dilatation. | 2880 minutes |
| Minutes to Rupture of Membranes (ROM) | Interval from study drug insertion to ROM. | 2880 minutes |
| Duration of Stay in Minutes in Labor and Delivery Suite | Minutes in Labor and Delivery (L & D) suite starting from insertion of the study drug to discharge from L & D to post partum care. | 5760 minuts |
| Days in Hospital for Mother and Neonate | Duration of stay in hospital for mother and neonate starting with insertion of the study drug and ending with discharge from the hospital. | 10 days |
| Mesa |
| Arizona |
| 85202 |
| United States |
| Maricopa Medical Center | Phoenix | Arizona | 85008 | United States |
| Arizona Wellness Center for Women | Phoenix | Arizona | 85032 | United States |
| Tuscon Medical Center | Tucson | Arizona | 85716 | United States |
| Long Beach Memorial Medical Center | Long Beach | California | 90806 | United States |
| UCI Medical Center | Orange | California | 92868 | United States |
| Santa Clara Valley Medical Center | San Jose | California | 95128 | United States |
| Christiana Care Health System | Newark | Delaware | 19718 | United States |
| Bayfront Medical Center | St. Petersburg | Florida | 33701 | United States |
| University of Florida Health Sciences Center | Tampa | Florida | 33606 | United States |
| St. Mary's Medical Center | West Palm Beach | Florida | 33401 | United States |
| Northside Hospital | Alpharetta | Georgia | 30005 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | United States |
| St. Elizabeth Regional Medical Center | Lincoln | Nebraska | 68510 | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962 | United States |
| University of New Mexico Medical Center | Albuquerque | New Mexico | 87131 | United States |
| United Health Services Hospitals, Inc. | Johnson City | New York | 13790 | United States |
| Winthrop-South Nassau University Health Center | Mineola | New York | 11501 | United States |
| NYU School of Medicine | New York | New York | 10016 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| Women's Health Alliance | Winston-Salem | North Carolina | 27103 | United States |
| University of Cincinnati Holmes Hospital | Cincinnati | Ohio | 45267 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Legacy Center for Maternal-Fetal Medicine | Portland | Oregon | 97232 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19090 | United States |
| Lehigh Valley Medical Center | Allentown | Pennsylvania | 18103 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| University of Pittsburgh - Magee Women's Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| Trident Health System | North Charleston | South Carolina | 29406 | United States |
| Erlanger Hospital | Chattanooga | Tennessee | 37403 | United States |
| University of Tennesse Medical Center | Knoxville | Tennessee | 37920 | United States |
| Baptist Memorial Hospital | Memphis | Tennessee | 38119 | United States |
| Methodist Charlton Medical Center | Dallas | Texas | 75327 | United States |
| University of Texas Health Sciences Center at Houston | Houston | Texas | 77030 | United States |
| Kings Daughters Clinic | Temple | Texas | 76502 | United States |
| McKay-Dee Hospital | Ogden | Utah | 84403 | United States |
| St. Mark's Hospital | Salt Lake City | Utah | 84124 | United States |
| University of Utah Health Science Center | Salt Lake City | Utah | 84132 | United States |
| Jordan Valley Hospital | West Jordan | Utah | 84088 | United States |
| Pioneer Valley Hospital | West Valley City | Utah | 84120 | United States |
| Overlake Hospital Medical Center | Bellevue | Washington | 98004 | United States |
| Saint Clare's Hospital | Weston | Wisconsin | 54476 | United States |
| Women's Health Centre/General Hospital/Eastern Health | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| IWK Health Centre and Dalhousie University | Halifax | Nova Scotia | B3K 6R8 | Canada |
| University of Saskatchewan Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| 17077234 | Background | Ewert K, Powers B, Robertson S, Alfirevic Z. Controlled-release misoprostol vaginal insert in parous women for labor induction: a randomized controlled trial. Obstet Gynecol. 2006 Nov;108(5):1130-7. doi: 10.1097/01.AOG.0000239100.16166.5a. |
| 18827122 | Result | Wing DA; Misoprostol Vaginal Insert Consortium. Misoprostol vaginal insert compared with dinoprostone vaginal insert: a randomized controlled trial. Obstet Gynecol. 2008 Oct;112(4):801-12. doi: 10.1097/AOG.0b013e318187042e. |
| 19622986 | Result | Pevzner L, Rayburn WF, Rumney P, Wing DA. Factors predicting successful labor induction with dinoprostone and misoprostol vaginal inserts. Obstet Gynecol. 2009 Aug;114(2 Pt 1):261-267. doi: 10.1097/AOG.0b013e3181ad9377. |
| 28125096 | Derived | Hawkins JS, Stephenson M, Powers B, Wing DA. Diabetes mellitus: an independent predictor of duration of prostaglandin labor induction. J Perinatol. 2017 May;37(5):488-491. doi: 10.1038/jp.2016.270. Epub 2017 Jan 26. |
| 21225563 | Derived | Brennan MC, Pevzner L, Wing DA, Powers BL, Rayburn WF. Retention of dinoprostone vaginal insert beyond 12 hours for induction of labor. Am J Perinatol. 2011 Jun;28(6):479-84. doi: 10.1055/s-0030-1271208. Epub 2011 Jan 11. |
| FG002 | Cervidil 10 mg Vaginal Insert | Cervidil 10 mg vaginal insert over a period of up to 24h |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Misoprostol Vaginal Insert (MVI) 100 | Misoprostol vaginal insert 100 mcg over a period of up to 24 h |
| BG001 | Misoprostol Vaginal Insert (MVI) 50 | Misoprostol vaginal insert 50 mcg over a period of up to 24 h |
| BG002 | Cervidil 10 mg Vaginal Insert | Cervidil 10 mg vaginal insert over a period of up to 24h |
| BG003 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Parity | Nulliparaous = no previous vaginal delivery prior to 24 wks gestation Parous = at least one previous vaginal delivery after 24 weeks | Number | participants |
| |||||||||||||||
| modified Bishop score (mBS) | The mBS measures cervical softness. There are five elements assessed during a vaginal examination. Maximum mBS is 12: 0 to 3 for Dilation, 0 to 3 for Station, 0 to 2 for Consistency, 0 to 1 for Position, and 0 to 3 for Length of Cervix. A score of zero is a long, closed, thick firm cervix; a score of 12 indicates thin, completely soft, 100% effaced cervix. | Mean | Standard Deviation | Units on a scale of 0 (low) to 12 (most) |
|
| 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 | Minutes From Drug Insertion to Vaginal Delivery | Interval between time/date of insertion of study drug and time/date of neonate birth. This is a time-to-event analysis, there is no set time for the assessment. The endpoint occurs when the baby is born. 48 hours can be used as an approximate interval by which time most of the babies have been delivered. | This analysis is for time to vaginal delivery (interval from insertion of study drug into the vagina to the delivery of the neonate); patients delivered by cesarean section were censored from this time-to-event analysis using the longest interval for all participants from insertion of study drug to cesarean section delivery of neonate. | Posted | Median | 95% Confidence Interval | minutes | 2880 minutes |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With a Cesarean Section Delivery | Percentage of participants with cesarean delivery after study drug was administered. There is no set assessment time or date as the woman's labor may last hours or days. | Posted | Number | Percentage of participants | 2880 minutes |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events | This outcome reports the percentage of adverse events in each treatment arm spontaneously reported or observed during the study. The intrapartum period (mother is still pregnant) is called the "Maternal/Fetal" period; once the baby has been born, adverse events are assessed separately for the mother (Post Partum) and the baby (Neonatal). The number of adverse events was assessed separately for each of the three periods. | Analysis was based on intention to treat, i.e., all subjects who had the insert placed in the vagina. | Posted | Number | Percentage of participants | 96 hours |
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| Secondary | Percentage of Participants With Pre-Delivery Oxytocin Use | Incidence in each treatment group of need for oxytocin for pre-delivery induction or augmentation of labor. | This analysis included all participants exposed to study drug and for whom there was data available regarding whether oxytocin was used pre-delivery. | Posted | Number | Percentage of participants | 2880 minutes |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert | Measured the percentage of participants who achieved success on the mBS. This composite score is based on the mBS and vaginal delivery and it is measured 12 hours after insertion of the study drug. The mBS has a score of 0 when the cervix is not ripe and a score of 12 when completely ripened. The 12 hour score is compared to baseline. Using the mBS, assess at 12 hours whether each subject has met any of the following three criteria: 1) has improved (increased) the mBS by at least 3 points from baseline; 2) has reached a score of at least 6 on the mBS; or 3) has acheived a vaginal delivery. | Posted | Number | Percentage of Participants | 12 hours |
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| Secondary | Minutes to Onset of Active Labor | Interval from insertion of study drug to onset of active labor, defined as at least three contractions in a ten-minute period of at least moderate intensity and resulting in cervical change such as dilatation or effacement; OR at least 4 cm cervical dilatation achieved after progressive change in dilatation. | Posted | Mean | Standard Deviation | minutes | 2880 minutes |
|
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| Secondary | Minutes to Rupture of Membranes (ROM) | Interval from study drug insertion to ROM. | Posted | Median | 95% Confidence Interval | minutes | 2880 minutes |
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| Secondary | Duration of Stay in Minutes in Labor and Delivery Suite | Minutes in Labor and Delivery (L & D) suite starting from insertion of the study drug to discharge from L & D to post partum care. | Posted | Mean | Standard Deviation | minutes | 5760 minuts |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Days in Hospital for Mother and Neonate | Duration of stay in hospital for mother and neonate starting with insertion of the study drug and ending with discharge from the hospital. | Posted | Mean | Standard Deviation | days | 10 days |
|
|
96 hours
Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
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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 Vaginal Insert (MVI) 100 | Misoprostol vaginal insert 100 mcg over a period of up to 24 h | 106 | 428 | 130 | 428 | ||
| EG001 | Misoprostol Vaginal Insert (MVI) 50 | Misoprostol vaginal insert 50 mcg over a period of up to 24 h | 134 | 443 | 129 | 443 | ||
| EG002 | Cervidil 10 mg Vaginal Insert | Cervidil 10 mg vaginal insert over a period of up to 24h | 117 | 436 | 132 | 436 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrested Labor | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment | Also included terms such as Failure to progress |
|
| Cephalopelvic Disproportion | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Wolff-Parkinson-White Syndrome | Cardiac disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Herpes Simplex | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| Abnormal Labor Affecting Fetus | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| Chorioamnionitis | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| Foetal heart rate disorder | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| Foetal malpresentation | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| Pregnancy-induced hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| Premature separation of placenta | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| umbilical cord prolapse | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| uterine contractions abnormal | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| uterine hypertonus | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| congestive cardiomyopathy | Cardiac disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Chest pain | Cardiac disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Liver abscess | Hepatobiliary disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Endometritis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| cellulitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| pyelonephritis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| wound infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| urine output decreased | Investigations | MedDRA (6.1) | Non-systematic Assessment |
| |
| peroneal nerve palsy | Nervous system disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| postpartum hemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| preeclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| nephrolithiasis | Renal and urinary disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| urinary retention | Renal and urinary disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| uterine atony | Reproductive system and breast disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| hypertension | Vascular disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| polycythaemia | Blood and lymphatic system disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| bradycardia neonatal | Cardiac disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| tachcardia foetal | Cardiac disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| congenital anomaly | Congenital, familial and genetic disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Neonatal hypothermia | General disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| hyperbilirubinemia neonatal | Hepatobiliary disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Group B sepsis neonatal | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| sepsis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| Apgar score low | Investigations | MedDRA (6.1) | Non-systematic Assessment |
| |
| ABO hemolytic disease of the newborn | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| cephalohaematoma | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| jaundice | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| neonatal aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| neonatal respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| transient tachypnea of the newborn | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| infection prophylaxis | Surgical and medical procedures | MedDRA (6.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal labour affecting foetus | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| Chorioamnionitis | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| Foetal heart rate disorder | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| Meconium in amniotic fluid | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| uterine contractions abnormal | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| uterine hypertonus | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Perineal laceration | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| post partum hemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| neonatal hyperbilirubinemia | Hepatobiliary disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Apgar score low | Investigations | MedDRA (6.1) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara L. Powers | Cytokine PharmaSciences, Inc. | 610-687-1776 | 214 | bpowers@cytokinepharmasciences.com |
| ID | Term |
|---|---|
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Canada |
|
| Parous |
|
| Log Rank | 0.011 | Cox Proportional Hazard | 1977 | 95 | 1977 | 2253 | No | Superiority or Other |
|
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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