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It was discovered that the patient population would not be large enough to adequately recruit.
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| Name | Class |
|---|---|
| Harris Health System, Lyndon B Johnson Hospital obstetrics and gynecology clinic | UNKNOWN |
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The purpose of this study is to compare the incidence of composite neonatal morbidity and birthweight >4500 grams among uncomplicated large for gestational age (LGA) fetal growth at delivered 37 weeks versus expectant management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Labor induction at 37.0 weeks to 37.6 weeks of gestation | Experimental | Diagnosis of LGA with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days |
|
| Expectant monitoring and delivery | Active Comparator | Diagnosis of LGA with expectant monitoring and delivery as indicated by standard obstetric practices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Labor induction at 37.0 weeks to 37.6 weeks of gestation | Procedure | Diagnosis of LGA with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of children presenting with CNM | Composite neonatal morbidity (CNM) is any of the following: Apgar score <5 at 5 minutes, seizure, fracture of skull, humerus, or clavicle, neonatal brachial plexus palsy, facial nerve palsy, oxygen supplementation >4 hours, CPAP >2 hours, mechanical ventilation, or death before discharge or IUFD. | Up to 6 weeks after delivery |
| Number of children with birthweight above 4500 grams | Immediately at birth |
| Measure | Description | Time Frame |
|---|---|---|
| Number of women presenting with CMM | Composite maternal morbidity (CMM) is any of the following: chorioamnionitis, shoulder dystocia, 3rd or 4th degree laceration or episiotomy, transfusion of blood products, endometritis, wound infection or separation, deep venous thrombosis, pulmonary embolism, admission to the intensive care unit, or death. Rates of cesarean section as well as indications in each group will also be evaluated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Baha M Sibai, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
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| ID | Term |
|---|---|
| D005320 | Fetal Macrosomia |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D011247 | Pregnancy |
| D036801 | Parturition |
| ID | Term |
|---|---|
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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| Expectant monitoring and delivery | Procedure | Diagnosis of LGA with expectant monitoring and delivery as indicated by standard obstetric practices |
|
| Up to 6 weeks after delivery |
| Number of children delivered by cesarean section | Immediately at birth |
| Number of children admitted to NICU | NICU is neo-natal intensive care unit | Up to 6 weeks after delivery |
| D005315 | Fetal Diseases |
| D011254 | Pregnancy in Diabetics |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001724 | Birth Weight |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |