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| ID | Type | Description | Link |
|---|---|---|---|
| OBX 0012 | Other Identifier | Obstetrix CREQ Protocol Number |
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Hypothesis: Among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal morbidity by reducing the rate of preterm delivery.
This study involves two concurrent double-blinded randomized clinical trials of 17OHP versus placebo. Each trial will test the efficacy and safety of 17OHP in women with a specific risk factor for preterm birth. The two risk factors to be studied are:
Prematurity is a leading cause of neonatal morbidity and mortality in the USA. Nationally, 12% of all babies deliver before term and 3% deliver before 32 wks gestational age (GA). Recent studies suggest that 17OHP and other progesterone derivatives may reduce the rate of preterm birth among women with a history of prior preterm birth. However, it has not been demonstrated that this reduction in preterm birth is accompanied by a clinically significant reduction in neonatal complications. Further, most women who deliver preterm have no history of a prior preterm birth. Little is known about whether progesterone treatment is effective in women with other risk factors for preterm birth such as multiple gestation. The proposed study will assess the role of 17OHP in women with twin or triplet pregnancies and will assess the impact on neonatal health, not merely the impact on gestational age at delivery. Prior studies were not designed to be large enough to have statistical power to assess effects on neonatal morbidity.
In the 6 trials combined in the Goldstein meta-analysis, only 279 women were treated with 17OHP and only 73 women had a preterm delivery. The NICHD study presented by Meis approximately doubles the world-wide experience, with 306 women under treatment, of whom 73 delivered prior to 35 wks. Yet, this study was not designed to have power to show a reduction in neonatal complications but only a reduction in preterm birth rates.
The present study is the first to be specifically designed to have adequate power to test whether 17OHP reduces neonatal morbidity among women with one of two specific risk factors for preterm birth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Test Group (170HP) | Active Comparator | Test Group will receive weekly doses of 170HP via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first. |
|
| 2 - Control (Normal Saline) | Placebo Comparator | Control Group will receive weekly doses of placebo (NS) via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17-alpha-hydroxyprogesterone caproate injectable | Drug | 250mg of 17-alpha-hydroxyprogesterone caproate (+ preservatives) injectable weekly starting as early as 19wks gestation until 34.0wks gestation of delivery which ever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| Newborn Respiratory Distress Syndrome (RDS) | Newborn RDS in the twin arm is defined as compatible symptoms with radiographically confirmed hyaline membrane disease or with respiratory insufficiency of prematurity requiring ventilator support. Data expressed as mean n(%),Odds ratio, CI, and P-value were determined using repeated measures model wherein each twin/triplet within a given pregnancy is considered a repeated measure. Exceptions are comparison with 0 outcomes in one or both groups, so Fisher's Exact Test was used. Morbidity measures were based on live births with data available for the outcomes. | Measured from delivery until 30 days after baby was discharged from the hospital |
| Use of Oxygen Therapy at 28 Days of Newborn Life | Supplemental oxygen use by the baby measured at the point that the baby reaches 28 days old (after birth)within the twin group. | Measured at 28 days after birth. |
| Newborn Sepsis | Newborn Sepsis in the twin group was defined as the presence of positive blood culture obtained in the first week of life in association with clinical findings suggesting illness for which the neonate received antibiotics. | measured during the first week following birth |
| Newborn Pneumonia | Newborn Pneumonia in the twin group is described as compatible symptoms with diagnostic radiograph findings and positive results on blood cultures, persistent leukopenia | measure during the first 28 days after birth. |
| Newborn Intraventricular Hemorrhage Grade 3 or 4 | Newborn Intraventricular hemorrhage (IVH) Stage III in the twin group is described as - IVH with ventricular dilatation. Neonatal Intraventricular hemorrhage (IVH)Stage IV in the twin group is described as - IVH with parenchymal extension. |
| Measure | Description | Time Frame |
|---|---|---|
| Individual Components of Neonatal Morbidity (RDS, IVH-III/IV, Bronchopulmonary Dysplasia(BPD), PVL, Sepsis, NEC, ROP-Stage 3/4, Perinatal Death) | Composite Neonatal Morbidity within the twin group is described as the presence of any one or more of the following neonatal morbidities (RDS, IVH-III/IV, BPD, PVL, sepsis, NEC, ROP-Stage 3/4, Perinatal Death). | measured as any event noted in the first 28 day following birth. |
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Inclusion Criteria:
Gestational age (GA) 15-23w0d gestational age at the time of recruitment
GA 16w0dk to 23w6d at the time of randomization and initiation of injections
Maternal age 18 years or older
One of these risk factors for spontaneous preterm birth:
Intact membranes
Patient has had at least one detailed 2nd-trimester ultrasound examination documenting placentation, chorionicity, fetal number, fetal size, amniotic fluid volumes, and fetal anatomy. (This examination must comply with minimum standards such as those published by the American Institute of Ultrasound in Medicine, American College of Radiology, or American College of Obstetricians & Gynecologists It is NOT mandatory that this examination be performed at the research-study center.)
Investigator believes patient will be reliable with follow-up visits and believes that delivery data and neonatal data are likely to be available.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Maurel, RN, MSN, CNS | Obstetrix Medical Group, Inc. | Study Director |
| Andrew Combs, MD | Obstetrix Medical Group, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Good Samaritan Hospital | Phoenix | Arizona | 85006 | United States | ||
| Tucson Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2653414 | Background | Goldstein P, Berrier J, Rosen S, Sacks HS, Chalmers TC. A meta-analysis of randomized control trials of progestational agents in pregnancy. Br J Obstet Gynaecol. 1989 Mar;96(3):265-74. doi: 10.1111/j.1471-0528.1989.tb02385.x. | |
| 12592250 | Background | da Fonseca EB, Bittar RE, Carvalho MH, Zugaib M. Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study. Am J Obstet Gynecol. 2003 Feb;188(2):419-24. doi: 10.1067/mob.2003.41. |
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During the pre-assignment period, subjects were consented to participate, giving a compliance injection of Castor Oil and brought back 5 to 9 days later for re-evaluation. Exclusions were made based on the presence of a reaction to the injection, not meeting inclusion/exclusion criteria or the participates desire not to participate.
Potential women carrying a twin or triplet pregnancy meeting defined inclusion and exclusion criteria were recruited from participating outpatient medical clinics from November, 2004 to August 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Test Group (170HP) | Test Group will receive a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first. |
| FG001 | 2 - Control (Castor Oil) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Weekly doses of placebo (NS + preservatives) via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first. |
|
|
| measured during the first 28 days after birth |
| Newborn Periventricular Leukomalacia (PVL) | Newborn Periventricular leukomalacia (PVL) in the twin group is described as the presence of more than 1 obvious hypo echoic cyst in the periventricular white matter. | measured in the first 28 days after birth. |
| Newborn Necrotizing Enterocolitis (NEC)Requiring Surgery | Newborn NEC in the twin group is described as the presence of any of the following: (1)unequivocal intramural air in abdominal radiograph; (2) perforation abdominal radiograph; (3) clinical evidence of perforation (erythema and induration of the abdominal wall or intrabdominal abscess formation); (4) characteristic findings observed at surgery or autopsy; (5) Stricture formation after an episode of suspected necrotizing enterocolitis. | measured in the first 28 days after birth |
| Newborn Retinopathy of Prematurity (ROP) | Newborn ROP within the twin group is described as retinopathy confirmed on fundoscopic examination, felt to be due to prematurity and subsequent oxygen therapy. | measured during the first 28 day after birth |
| Newborn Asphyxia With Ischemic Injury of Brain, Heart, Kidneys, or Liver | Newborn Asphyxia or Hypoxic-ischemic encephalopathy (HEI) within the twin group is characterized by clinical and laboratory evidence of acute or subacute brain injury due to asphyxia (ie, hypoxia, acidosis). | measured during the first 28 days after delivery |
| Perinatal Death | Perinatal death within the twin group is described as a stillbirth, neonatal death, or miscarriage after randomization. | measured from randomization to 28 days after birth. |
| Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks | Gestational age was noted at time of delivery and stratified into three categories (Twins: Delivery prior to 28 weeks (wks), 32 wks, 34 wks, and 37 wks) | Gestational age noted at time of birth |
| Triplets: Delivery Prior to 28 Wks, 32 Wks, 35 Wks | Gestational age was noted at time of delivery and stratified into three categories (Triplets: Delivery prior to 28 wks, 32 wks, 35 wks) | noted at delivery |
| Newborn Gestational Age (GA) at Delivery | Newborn Gestational age at delivery within the twin group is described as the gestational age of the baby on the day of birth. | determined at the time of birth |
| Newborn Birthweight | Newborn Birthweight within the twins group was measure following delivery and noted in grams. | measure following delivery |
| Participant Drop-out Rates | Drop-out rates in the twin group are described as any randomized participant who is withdrawn from the trial between randomization (as early at 16 weeks of pregnancy) and completion of the final dose of study medication (as late as 34 weeks of pregnancy). | any time from randomization to completion of final dose of study medication |
| Participant Side Effects Requiring Cessation of Therapy | Describe as the cessation of study related therapy for the participant within the twin group at anytime from initial study related injection until the final injection at 34 weeks of pregnancy. | anytime from initial injection to final injection at 34 weeks. |
| Tucson |
| Arizona |
| 85712 |
| United States |
| Saddleback Memorial Medical Center | Laguna Hills | California | 92653 | United States |
| Long Beach Memorial Medical Center | Long Beach | California | 90801-1428 | United States |
| University of Southern California-Irvine Medical Center | Orange | California | 92868 | United States |
| Good Samaritan Hospital | San Jose | California | 95124 | United States |
| Swedish Medical Center | Denver | Colorado | 80110 | United States |
| Presbyterian/St Luke's Hospital | Denver | Colorado | 80218 | United States |
| Rose Medical Center | Denver | Colorado | 80220 | United States |
| Skyridge Medical Center | Lonetree | Colorado | 80124 | United States |
| Mercy Medical Center | Des Moines | Iowa | 50314 | United States |
| Saint Luke's Hospital, Kansas City | Kansas City | Missouri | 64111 | United States |
| Erlanger Medical Center | Chattanooga | Tennessee | 37403 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Harris Methodist Fort Worth Hospital | Fort Worth | Texas | 76104 | United States |
| Evergreen Hospital | Kirkland | Washington | 98034 | United States |
| Swedish Medical Center | Seattle | Washington | 98122-4307 | United States |
| Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| 12802023 | Background | Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, Spong CY, Hauth JC, Miodovnik M, Varner MW, Leveno KJ, Caritis SN, Iams JD, Wapner RJ, Conway D, O'Sullivan MJ, Carpenter M, Mercer B, Ramin SM, Thorp JM, Peaceman AM, Gabbe S; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003 Jun 12;348(24):2379-85. doi: 10.1056/NEJMoa035140. |
| Background | American College of Obstetricians & Gynecologists. Special problems of multiple gestation. Educational Bulletin 253, 1998. |
Control Group will receive a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Test Group (170HP) | Test Group will receive a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first. |
| BG001 | 2 - Control (Castor Oil) | Control Group will receive a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first. |
| BG002 | 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 |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Newborn Respiratory Distress Syndrome (RDS) | Newborn RDS in the twin arm is defined as compatible symptoms with radiographically confirmed hyaline membrane disease or with respiratory insufficiency of prematurity requiring ventilator support. Data expressed as mean n(%),Odds ratio, CI, and P-value were determined using repeated measures model wherein each twin/triplet within a given pregnancy is considered a repeated measure. Exceptions are comparison with 0 outcomes in one or both groups, so Fisher's Exact Test was used. Morbidity measures were based on live births with data available for the outcomes. | Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (319) vs. babies born to mothers in placebo arm(153)) | Posted | Number | Twins | Measured from delivery until 30 days after baby was discharged from the hospital |
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| |||||||||||||||||||||||||||||
| Primary | Use of Oxygen Therapy at 28 Days of Newborn Life | Supplemental oxygen use by the baby measured at the point that the baby reaches 28 days old (after birth)within the twin group. | Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (308) vs. babies born to mothers in placebo arm(150)) | Posted | Number | Twins | Measured at 28 days after birth. |
|
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| Primary | Newborn Sepsis | Newborn Sepsis in the twin group was defined as the presence of positive blood culture obtained in the first week of life in association with clinical findings suggesting illness for which the neonate received antibiotics. | The participants were randomized in a two to one fashion (2=active participants to every 1=placebo participant). The number of participated included were based on an intent to treat protocol. | Posted | Number | participants | measured during the first week following birth |
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| Primary | Newborn Pneumonia | Newborn Pneumonia in the twin group is described as compatible symptoms with diagnostic radiograph findings and positive results on blood cultures, persistent leukopenia | Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(154)) | Posted | Number | Twins | measure during the first 28 days after birth. |
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| Primary | Newborn Intraventricular Hemorrhage Grade 3 or 4 | Newborn Intraventricular hemorrhage (IVH) Stage III in the twin group is described as - IVH with ventricular dilatation. Neonatal Intraventricular hemorrhage (IVH)Stage IV in the twin group is described as - IVH with parenchymal extension. | Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (316) vs. babies born to mothers in placebo arm(152)) | Posted | Number | Twins | measured during the first 28 days after birth |
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| Primary | Newborn Periventricular Leukomalacia (PVL) | Newborn Periventricular leukomalacia (PVL) in the twin group is described as the presence of more than 1 obvious hypo echoic cyst in the periventricular white matter. | The participants were randomized in a two to one fashion (2=active participants to every 1=placebo participant). The number of participants for analysis was determined using an intention to treat protocol. | Posted | Number | participants | measured in the first 28 days after birth. |
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| Primary | Newborn Necrotizing Enterocolitis (NEC)Requiring Surgery | Newborn NEC in the twin group is described as the presence of any of the following: (1)unequivocal intramural air in abdominal radiograph; (2) perforation abdominal radiograph; (3) clinical evidence of perforation (erythema and induration of the abdominal wall or intrabdominal abscess formation); (4) characteristic findings observed at surgery or autopsy; (5) Stricture formation after an episode of suspected necrotizing enterocolitis. | Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (315) vs. babies born to mothers in placebo arm(152)) | Posted | Number | Twins | measured in the first 28 days after birth |
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| Primary | Newborn Retinopathy of Prematurity (ROP) | Newborn ROP within the twin group is described as retinopathy confirmed on fundoscopic examination, felt to be due to prematurity and subsequent oxygen therapy. | Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (308) vs. babies born to mothers in placebo arm(145)) | Posted | Number | Twins | measured during the first 28 day after birth |
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| Primary | Newborn Asphyxia With Ischemic Injury of Brain, Heart, Kidneys, or Liver | Newborn Asphyxia or Hypoxic-ischemic encephalopathy (HEI) within the twin group is characterized by clinical and laboratory evidence of acute or subacute brain injury due to asphyxia (ie, hypoxia, acidosis). | Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (274) vs. babies born to mothers in placebo arm(130)) | Posted | Number | Twins | measured during the first 28 days after delivery |
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| Secondary | Individual Components of Neonatal Morbidity (RDS, IVH-III/IV, Bronchopulmonary Dysplasia(BPD), PVL, Sepsis, NEC, ROP-Stage 3/4, Perinatal Death) | Composite Neonatal Morbidity within the twin group is described as the presence of any one or more of the following neonatal morbidities (RDS, IVH-III/IV, BPD, PVL, sepsis, NEC, ROP-Stage 3/4, Perinatal Death). | Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(155)) | Posted | Number | Twins - Components of Neonatal Morbidity | measured as any event noted in the first 28 day following birth. |
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| Secondary | Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks | Gestational age was noted at time of delivery and stratified into three categories (Twins: Delivery prior to 28 weeks (wks), 32 wks, 34 wks, and 37 wks) | Population analysed were total pregnancies of mothers with twin gestation (ie. active group 160 and placebo group 80) | Posted | Number | Twin Pregnancies | Gestational age noted at time of birth |
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| Secondary | Triplets: Delivery Prior to 28 Wks, 32 Wks, 35 Wks | Gestational age was noted at time of delivery and stratified into three categories (Triplets: Delivery prior to 28 wks, 32 wks, 35 wks) | Population analysed were total pregnant mothers with triplet gestations (ie. active group 160 and placebo group 80) | Posted | Number | Triplet Pregnancies | noted at delivery |
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| Secondary | Newborn Gestational Age (GA) at Delivery | Newborn Gestational age at delivery within the twin group is described as the gestational age of the baby on the day of birth. | Population analysed were total pregnant mothers with twin gestations (ie. active group 160 and placebo group 80) | Posted | Mean | Standard Deviation | weeks of age for twin pregnancy | determined at the time of birth |
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| Secondary | Newborn Birthweight | Newborn Birthweight within the twins group was measure following delivery and noted in grams. | Population analysed were twins from twin pregnancies (ie. active group 160 and placebo group 80) | Posted | Mean | Standard Deviation | grams | measure following delivery |
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| Secondary | Participant Drop-out Rates | Drop-out rates in the twin group are described as any randomized participant who is withdrawn from the trial between randomization (as early at 16 weeks of pregnancy) and completion of the final dose of study medication (as late as 34 weeks of pregnancy). | Population analysed were total pregnant mothers (participants) with twin gestation (ie. active group 160 and placebo group 80) | Posted | Number | participants | any time from randomization to completion of final dose of study medication |
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| Secondary | Participant Side Effects Requiring Cessation of Therapy | Describe as the cessation of study related therapy for the participant within the twin group at anytime from initial study related injection until the final injection at 34 weeks of pregnancy. | Population analysed were total pregnant mothers (participants) with twin gestation (ie. active group 160 and placebo group 80) | Posted | Number | participants | anytime from initial injection to final injection at 34 weeks. |
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| Primary | Perinatal Death | Perinatal death within the twin group is described as a stillbirth, neonatal death, or miscarriage after randomization. | Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(156)) | Posted | Number | Twins | measured from randomization to 28 days after birth. |
|
|
Adverse events were collected during the 4.9 years the trial was actively enrolling subjects. For each randomized participant, adverse events were captured from randomization until the participant and her baby were discharged from the hospital.
Assessments were both Systematic & Non-systematic: standard questionnaire, regular investigator assessment, regular laboratory testing, systematic evaluation of medical record, self-reporting by participants, occasional assessment/testing
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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 | Test Group (170HP) | Both Twins and Triplets in the Test Group received a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever came first. | 69 | 216 | 40 | 216 | ||
| EG001 | Control (Castor Oil) | Both Twins and Triplets in the Control Group received a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever came first. | 34 | 105 | 18 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postpartum Hemorrhage requiring blood transfusion | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
| |
| Acute Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Maternal Anemia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Maternal Anemia following intrapartum bleeding. |
| |
| Bladder Trauma | Surgical and medical procedures | Systematic Assessment | Bladder trauma during cesarean section |
| |
| Neonatal Bowel Perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neonatal Cardiac Abnormalities | Congenital, familial and genetic disorders | Systematic Assessment | Neonatal Congenital Cardiac abnormalities such as Ventricular Septal Defect (VSD), Atrial Septal Defect (ASD) ,Patent Ductus Arteriosis (PDA) |
| |
| Maternal Cellulitis | Infections and infestations | Systematic Assessment | maternal cellulitis at intramuscular injection site |
| |
| Maternal Chorioamnionities necessitating preterm delivery | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Neonatal Chronic Lung Disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Neonatal Congenital Hypospadium | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Congenital Abnormality | Congenital, familial and genetic disorders | Systematic Assessment | neonatal congenital abnormality such as club foot, cleft palate, gastroschisis, tracheal stenosis, Hydrocele, duodenal atresia, sigmoid stricture, PDA requiring ligation. |
| |
| Neonatal Cranial Synostosis | Nervous system disorders | Systematic Assessment |
| ||
| Deep Vein Thrombosis (DVT) | Vascular disorders | Systematic Assessment |
| ||
| Endometritis | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Neonatal Gastroschisis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neonatal Intraventricular Hemorrhage (Stage III or IV) | Vascular disorders | Systematic Assessment |
| ||
| Maternal HELLP Syndrome | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Neonatal Hypoplastic Lung | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Intrauterine Fetal Demise (IUFD) | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Miscarriage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Neonatal Necrotizing Enterocolitis (NEC) | Gastrointestinal disorders | Systematic Assessment |
| ||
| Non-Occulusive Thrombus | Vascular disorders | Systematic Assessment |
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| Peripartum Cardiomyopathy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Neonatal Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Neonatal Pneumothorax | Reproductive system and breast disorders | Systematic Assessment |
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| Neonatal Post Hemorrhagic Hydrocephalus | Nervous system disorders | Systematic Assessment |
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| Neonatal Peripheral Pulmonary Stenosis | Congenital, familial and genetic disorders | Systematic Assessment |
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| Severe Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Prolonged Hospitalization - Maternal Urinary Retention | Renal and urinary disorders | Systematic Assessment |
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| Maternal Pyelonephritis | Renal and urinary disorders | Systematic Assessment |
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| Maternal Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Compatible symptoms with diagnostic radiograph findings and positive results on blood cultures,persistent leukopenia |
| |
| Neonatal Readmissions to the hospital | General disorders | Non-systematic Assessment | Neonatal readmission to the hospital after discharge = such as temperature instability, sepsis, nutritional support and apnea |
| |
| Neonatal Sepsis | Infections and infestations | Non-systematic Assessment | diagnosed by clinical or laboratory findings |
| |
| Maternal Supraventricular Tachycardia (SVT) | Cardiac disorders | Non-systematic Assessment |
| ||
| Maternal Hematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Maternal Wound Eviceration post Cesarean Section | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Nectrotizing Enterocolitis (NEC) | General disorders | Non-systematic Assessment |
| ||
| Neonatal Meningitis | Infections and infestations | Non-systematic Assessment |
| ||
| Inguinal Hernia requiring surgical repair | Surgical and medical procedures | Non-systematic Assessment |
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| Uterine Atony | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Maternal Pyelonephritis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Retained Products of Conception | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gestational Diabetes | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Maurel | Obstetrix Medical Group, Inc | 714-593-9171 | kimberly_maurel@pediatrix.com |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| >=65 years |
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| triplets |
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| Male |
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