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The goal of the study is to determine whether labor induction at 37 weeks of pregnancy can improve the baby's health at birth when compared with delivery at a later point in the pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Labor induction at 37.0 to 37.6 weeks of gestation | Experimental | Diagnosis of FGR with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days |
|
| Expectant monitoring until delivery | Active Comparator | Diagnosis of FGR managed with expectant monitoring and delivery as indicated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Labor induction at 37.0 to 37.6 weeks of gestation | Procedure | Diagnosis of FGR with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of children with birthweight less than the third percentile for gestational as assessed by NICHD nomograms | NICHD is National Institute of Child Health and Human Development The NICHD nomogram will indicate their birth weight percentile based on their gestational age and ethnicity | Immediately at birth |
| Measure | Description | Time Frame |
|---|---|---|
| Number of children presenting with CNM | Composite neo-natal morbidity (CNM) is any of the following: Apgar score <5 at 5 minutes, seizure, sepsis, hypoglycemia requiring intravenous treatment, mechanical ventilation, CPAP (continuous positive airway pressure) or high-flow nasal cannula for >2 hours, oxygen supplementation with FiO2 (fraction of inspired oxygen) >30% for >4 hours, death before discharge or IUFD (intrauterine fetal death). |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Baha M Sibai, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hermann Memorial City Medical Center | Houston | Texas | 77024 | United States | ||
| The University of Texas Health Science Center at Houston |
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D011247 | Pregnancy |
| ID | Term |
|---|---|
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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| Expectant monitoring until delivery | Procedure | Diagnosis of FGR managed with expectant monitoring and delivery as indicated |
|
| Up to 6 weeks after delivery |
| Number of women presenting with CMM | Composite maternal morbidity (CMM) is any of the following: chorioamnionitis, 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. | 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 |
| Number of children presenting with SGA | SGA is small for gestational age when birthweight <10% for gestational age | Immediately at birth |
| Houston |
| Texas |
| 77030 |
| United States |
| Bellaire - Memorial Hermann | Houston | Texas | 77401 | United States |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |