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| ID | Type | Description | Link |
|---|---|---|---|
| OBX0001 | Other Identifier | Obstetrix Medical Group |
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The hypothesis is that administration of two courses of antenatal corticosteroids, compared to one course, will show a 40% reduction in the incidence of composite neonatal morbidity in patients delivering prior to 34 weeks' gestation.
This is a randomized double-blinded placebo-controlled trial. The objective of this study is to evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity including respiratory distress syndrome in patients delivering prior to 34 weeks' gestation in a randomized prospective fashion.
Preterm delivery occurs in approximately 10% of all deliveries in the United States. Preterm birth is the cause of 75% of neonatal mortality not mentioning the significantly increased morbidity from respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and sepsis. Numerous studies have evaluated the safety and efficacy of antenatal corticosteroid (ACS) administration in threatened preterm labor.
National Institutes of Health (NIH) first consensus conference in 1994 evaluated the research in this field. Conclusions included the clear evidence that antenatal corticosteroids decrease the incidence of RDS in infants born at 29-34 weeks gestation, with a decrease in RDS severity for infants born at 24-28 weeks gestation and a decrease in the incidence of intraventricular hemorrhage in infants born at 24-28 weeks gestation without harm to mother or fetus. Their recommendation was to give a single course of corticosteroids to all pregnant women between 24 and 34 weeks gestation who are at risk of preterm delivery within 7 days.
Since the studies on the duration of the effects of antenatal corticosteroids in the fetus are not conclusive, many obstetricians repeat corticosteroids weekly or bi-weekly to patients continuing to be at risk for preterm delivery. Lacking scientific evidence, many investigators have performed retrospective analyses regarding the effects of single-course versus multiple-course antenatal corticosteroids.
The NIH consensus panel reconvened in 2000 and concluded that studies regarding repeated courses of corticosteroids are suggestive of possible benefits, especially in reduction of RDS, however, design flaws limit their validity.
The more recent publication from Caughey and Parer examined the literature for evidence regarding a dose response of the benefits and detriments of antenatal corticosteroids. Based on their complex mathematical analysis they recommend all fetus' between 24 and 34 weeks' gestation at risk for preterm delivery should be given a first course of ANC. If the risk of preterm delivery persists the next course should be given 2 weeks later, for a maximum of two courses. Consistent with all previous articles, the call for a well designed randomized, controlled trial is made.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Test group | Active Comparator | Receive 2nd Course = Study drug (betamethasone or dexamethasone) |
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| 2 - Control | Placebo Comparator | Placebo group = received placebo course |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betamethasone or Dexamethasone (2nd course of ACS) | Drug | Course of Betamethasone or Dexamethasone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth. | This outcome measured the total number of neonates with Composite Neonatal morbidity who delivered at < 34 weeks gestation. Composite Morbidity consisted of respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death | From birth to 28 days of life |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational Age at (@) Delivery | Reported the average/mean Neonatal gestational age (GA) (reported in weeks of pregnancy) at the time of birth for both groups (ACS vs. Placebo). | gestational age at delivery in weeks of gestation |
| Neonatal Birth Weight Reported in Grams |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Maurel, RN, MSN, CNS | Obstetrix Medical Group, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desert Good Samaritan Hospital | Mesa | Arizona | 85202 | United States | ||
| Banner Good Sammaritan Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7728157 | Background | Effect of corticosteroids for fetal maturation on perinatal outcomes. NIH Consens Statement. 1994 Feb 28-Mar 2;12(2):1-24. | |
| 11275015 | Background | Vermillion ST, Soper DE, Newman RB. Is betamethasone effective longer than 7 days after treatment? Obstet Gynecol. 2001 Apr;97(4):491-3. doi: 10.1016/s0029-7844(00)01178-9. |
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no washout, run-in or transition events occurred between enrollment and group assignment.
Pregnant women were recruited at 18 private (15) and university (3) medical centers from May 2003 through February 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | "Rescue" Course of Betamethasone or Dexamethasone | Receive 2nd "Rescue" Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Course of Placebo (NS) |
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Measured mean Birth weights of Neonates in each arm as reported in grams on the birth record. |
| At time of Birth |
| Interuterine Growth Restriction (IUGR) or Small for Gestational Age(SGA)in Babies Delivering at < 34 Weeks Gestation. | Noted as the total number of Neonates delivering at < 34 weeks gestation for which their weights fell within the 10th percentile at time of birth. | Measured at birth. |
| Neonatal Head Circumference Taken at Time of Birth. | Reported as the average of all neonatal head circumferences (HC) taken at time of birth in each group. | Birth |
| Number of Babies Who Required Ventilatory Support Within the First 28 Days of Life. | The number of babies who required ventilatory support within the first 28 days of life. Equal to or great than 12 hours was considered one day. | birth to 28 days of life |
| Number of Neonates Who Required Surfactant Therapy After Birth. | The Number of neonates who required surfactant therapy within the first 28 days after birth. | Birth to 28 days of life |
| Number of Neonates With Pneumothorax | Total number of neonates with pneumothorax diagnosed postpartum. | birth to 28 days of life |
| Maternal Infectious Morbidity. | Total number of Mothers having Maternal infectious morbidity (e.g. endometritis & maternal sepsis) noted from birth through 28 days after birth | Up to 28 days after giving birth |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Tucson Medical Center | 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 Sourthern 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 |
| Tufts-New England Medical Center | Boston | Massachusetts | 02111 | United States |
| Saint Luke's Hospital, Kansas City | Kansas City | Missouri | 64111 | United States |
| Saint John's Regional Health Center | Springfield | Missouri | 65804 | United States |
| University Med. Ctr. of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| Sunrise Medical Center | Las Vegas | Nevada | 89109 | United States |
| Erlanger Medical Center | Chattanooga | Tennessee | 37403 | United States |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | United States |
| Evergreen Hospital | Kirkland | Washington | 98034 | United States |
| Swedish Medical Center | Seattle | Washington | 98122-4307 | United States |
| 11725806 | Background | Antenatal corticosteroids revisited: repeat courses. NIH Consens Statement. 2000 Aug 17-18;17(2):1-18. |
| 11585480 | Background | Guinn DA, Atkinson MW, Sullivan L, Lee M, MacGregor S, Parilla BV, Davies J, Hanlon-Lundberg K, Simpson L, Stone J, Wing D, Ogasawara K, Muraskas J. Single vs weekly courses of antenatal corticosteroids for women at risk of preterm delivery: A randomized controlled trial. JAMA. 2001 Oct 3;286(13):1581-7. doi: 10.1001/jama.286.13.1581. |
| 12066102 | Background | Caughey AB, Parer JT. Recommendations for repeat courses of antenatal corticosteroids: a decision analysis. Am J Obstet Gynecol. 2002 Jun;186(6):1221-6; discussion 1226-9. doi: 10.1067/mob.2002.123742. |
| Placebo (Normal Saline) |
Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate. The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | "Rescue" Course of Betamethasone or Dexamethasone | Receive 2nd "Rescue" Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart. |
| BG001 | Placebo (Normal Saline) | Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate. The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth. | This outcome measured the total number of neonates with Composite Neonatal morbidity who delivered at < 34 weeks gestation. Composite Morbidity consisted of respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death | This was an intent to treat protocol. In patients delivering before 34 weeks we estimated that the sample size of at least 217 subjects in each arm would be needed to have 80% power to detect a 40% reduction in neonatal morbidity (to 16.8%). | Posted | Aug 2010 | Number | participants | From birth to 28 days of life |
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| Secondary | Gestational Age at (@) Delivery | Reported the average/mean Neonatal gestational age (GA) (reported in weeks of pregnancy) at the time of birth for both groups (ACS vs. Placebo). | Modified intent to treat | Posted | Aug 2010 | Mean | Standard Deviation | Weeks | gestational age at delivery in weeks of gestation |
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| Secondary | Neonatal Birth Weight Reported in Grams | Measured mean Birth weights of Neonates in each arm as reported in grams on the birth record. | Intent to treat protocol | Posted | Aug 2010 | Mean | Standard Deviation | grams | At time of Birth |
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| Secondary | Interuterine Growth Restriction (IUGR) or Small for Gestational Age(SGA)in Babies Delivering at < 34 Weeks Gestation. | Noted as the total number of Neonates delivering at < 34 weeks gestation for which their weights fell within the 10th percentile at time of birth. | Intent to Treat | Posted | Aug 2010 | Number | paticipants | Measured at birth. |
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| Secondary | Neonatal Head Circumference Taken at Time of Birth. | Reported as the average of all neonatal head circumferences (HC) taken at time of birth in each group. | Intent to treat | Posted | Aug 2010 | Mean | Standard Deviation | centemeters (cm) | Birth |
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| Secondary | Number of Babies Who Required Ventilatory Support Within the First 28 Days of Life. | The number of babies who required ventilatory support within the first 28 days of life. Equal to or great than 12 hours was considered one day. | Intent to treat (ITT) | Posted | Aug 2010 | Number | participants | birth to 28 days of life |
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| Secondary | Number of Neonates Who Required Surfactant Therapy After Birth. | The Number of neonates who required surfactant therapy within the first 28 days after birth. | ITT | Posted | Aug 2010 | Number | participant | Birth to 28 days of life |
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| Secondary | Number of Neonates With Pneumothorax | Total number of neonates with pneumothorax diagnosed postpartum. | ITT | Posted | Aug 2010 | Number | participants | birth to 28 days of life |
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| Secondary | Maternal Infectious Morbidity. | Total number of Mothers having Maternal infectious morbidity (e.g. endometritis & maternal sepsis) noted from birth through 28 days after birth | ITT | Posted | Aug 2010 | Number | participants | Up to 28 days after giving birth |
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4 years and (&) 9 months
Evaluation of AEs occurred from randomization until 28days post delivery/discharge.
The difference in reporting number(#)of participants at risk reflects the group for which the event relates to.e.g.: neonatal event N 289=test arm & 288=placebo
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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 | "Rescue" Course of Betamethasone or Dexamethasone | Receive 2nd "Rescue" Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart. | 40 | 512 | 0 | 512 | ||
| EG001 | Placebo (Normal Saline) | Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate. The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart. | 41 | 502 | 0 | 502 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Congenital Defect | Congenital, familial and genetic disorders | Systematic Assessment | to include: Congenital heart defects, hypospadias, inguinal hernia, hydrocele, dysmorphology, Cleft Lip, VATERS. |
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| DIC | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Aortic Stenosis | Cardiac disorders | Non-systematic Assessment |
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| Cardiac Dysfunction | Cardiac disorders | Non-systematic Assessment | Arrhythmias, cardiomyopathy, hypoperfusion |
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| NEC | Gastrointestinal disorders | Non-systematic Assessment |
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| Small Bowel Rotation | Gastrointestinal disorders | Non-systematic Assessment |
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| Hyperbilirubenemia | Hepatobiliary disorders | Non-systematic Assessment |
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| Hepatosplenomegally | Hepatobiliary disorders | Non-systematic Assessment |
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| Wound infections | Infections and infestations | Non-systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Mastitis | Infections and infestations | Non-systematic Assessment |
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| Post delivery/C/S hemorrage | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Spinal Headache | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| soft tissue rectal mass | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Intraoperative Bladder Tear | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| PVL | Nervous system disorders | Non-systematic Assessment |
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| Intraventicular Hemorrage (Grade III, IV) | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Perinatal fetal demise | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| D & C for retained products | Surgical and medical procedures | Non-systematic Assessment |
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| Abruption | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Apnea/respiratory distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Bronchiolitis, Pulmonary Interstitial Glycogenesis |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Ruptured Appendix | Gastrointestinal disorders | Non-systematic Assessment |
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| Crohn's Disease | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly A. Maurel, MSN, CNS | Obstetrix Medical Group, Inc. | 714-593-9171 | kimberly_maurel@pediatrix.com |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D007752 | Obstetric Labor, Premature |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D003907 | Dexamethasone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| >=65 years |
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| Male |
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| No |
| Superiority or Other |
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