Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus
NCT ID: NCT03218735
Last Updated: 2017-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-07-12
2019-08-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Labor induction at 37.0 weeks to 37.6 weeks of gestation
Diagnosis of LGA with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days
Labor induction at 37.0 weeks to 37.6 weeks of gestation
Diagnosis of LGA with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days
Expectant monitoring and delivery
Diagnosis of LGA with expectant monitoring and delivery as indicated by standard obstetric practices
Expectant monitoring and delivery
Diagnosis of LGA with expectant monitoring and delivery as indicated by standard obstetric practices
Interventions
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Labor induction at 37.0 weeks to 37.6 weeks of gestation
Diagnosis of LGA with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days
Expectant monitoring and delivery
Diagnosis of LGA with expectant monitoring and delivery as indicated by standard obstetric practices
Eligibility Criteria
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Inclusion Criteria
* Plan for vaginal delivery. Patients with prior cesarean section are eligible if they are planning for a trial of labor after cesarean section.
* Gestational age 34 weeks 0 days to 37 weeks 0 days at time of enrollment
* Dating of pregnancy by last menstrual period consistent with an ultrasound, ultrasound \<21 weeks and 6 days of gestation, or known date of conception in the setting of in vitro fertilization
* No known major anomalies (anomalies requiring surgery antenatally or in the neonatal period, anomalies not compatible with life as determined by the physician)
* LGA defined as estimated fetal weight (EFW) \> 90th percentile by Hadlock formula but \<4500 grams
Exclusion Criteria
* Planned cesarean delivery
* Polyhydramnios
* Known major fetal anomalies
* Multiple gestation or selective reduction of multiple gestation after 14 weeks
* Previous stillbirth at term
* Indications for delivery at \<39 weeks. Common examples include:
* Placenta previa
* Placenta accreta
* Vasa previa
* History of classical cesarean section or myomectomy
* Human immunodeficiency virus (HIV)
* Oligohydramnios (low amniotic fluid, defined as maximum vertical pocket \<2.0cm)
* High-risk pregnancy as determined by the physician. Common examples include:
* Pre-gestational diabetes or gestational diabetes on medication
* Chronic hypertension on medication
* Maternal cardiac disease
* Asthma requiring oral steroids during pregnancy
* Chronic renal disease
* Antiphospholipid syndrome
* Hyperthyroidism
* Prior stillbirth
* Systemic lupus erythematous
* Hemoglobinopathies such as sickle cell disease
18 Years
39 Years
FEMALE
No
Sponsors
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Harris Health System, Lyndon B Johnson Hospital obstetrics and gynecology clinic
UNKNOWN
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Bahaeddine M Sibai
Professor
Principal Investigators
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Baha M Sibai, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Countries
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Other Identifiers
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HSC-MS-17-0110
Identifier Type: -
Identifier Source: org_study_id