Macrosomia, FetalTEAM LGANCT03218735
Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus
A study testing Labor induction at 37.0 weeks to 37.6 weeks of gestation and Expectant monitoring and delivery in people with Macrosomia, Fetal and Labor Induction, run by The University of Texas Health Science Center, Houston.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Macrosomia, Fetal, Labor Induction
- What is being tested?
- Labor induction at 37.0 weeks to 37.6 weeks of gestation and Expectant monitoring and delivery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 12 Jul 2017to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- 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
Who cannot join
- Pre-gestational diabetes or gestational diabetes on medication (oral or insulin, excluding metformin)
- Planned cesarean delivery
- Polyhydramnios
- Known major fetal anomalies
- Multiple gestation or selective reduction of multiple gestation after 14 weeks
- Previous stillbirth at term
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- 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
About this study
Official title: Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus (TEAM LGA Trial)
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.
- Conditions
- Macrosomia, Fetal, Labor Induction
- Being tested
- Labor induction at 37.0 weeks to 37.6 weeks of gestation, Expectant monitoring and delivery
- Keywords
- large for gestational age fetal growth
- Medical subject headings
- Fetal Macrosomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labor induction at 37.0 weeks to 37.6 weeks of gestationProcedure or surgery
Diagnosis of LGA with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days
Expectant monitoring and deliveryProcedure or surgery
Diagnosis of LGA with expectant monitoring and delivery as indicated by standard obstetric practices
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Labor induction at 37.0 weeks to 37.6 weeks of gestation |
| Expectant monitoring and delivery | Active comparator | Diagnosis of LGA with expectant monitoring and delivery as indicated by standard obstetric practices Receives: Procedure: Expectant monitoring and delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 weeks after delivery
Number of children with birthweight above 4500 grams
Measured: Immediately at birth
Secondary outcomes (3)
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.
Measured: Up to 6 weeks after delivery
Number of children delivered by cesarean section
Measured: Immediately at birth
Number of children admitted to NICU
NICU is neo-natal intensive care unit
Measured: Up to 6 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start12 Jul 2017
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Why it stopped: It was discovered that the patient population would not be large enough to adequately recruit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macrosomia, FetalStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Harris Health System, Lyndon B Johnson Hospital obstetrics and gynecology clinic
- Responsible party
- Principal investigator, Bahaeddine M Sibai, The University of Texas Health Science Center, Houston
- Investigators
- Baha M Sibai, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218735
- Sponsor's protocol ID
- HSC-MS-17-0110
- Acronym
- TEAM LGA
- Status last verified
- Dec 2017
- First submitted
- 12 Jul 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus (TEAM LGA Trial)
- ClinicalTrials.gov ID
- NCT03218735
- Acronym / sponsor ID
- TEAM LGA / HSC-MS-17-0110
- Conditions
- Macrosomia, Fetal, Labor Induction
- Keywords
- large for gestational age fetal growth
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was discovered that the patient population would not be large enough to adequately recruit.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Harris Health System, Lyndon B Johnson Hospital obstetrics and gynecology clinic
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Labor induction at 37.0 weeks to 37.6 weeks of gestation | Experimental | Procedure: Labor induction at 37.0 weeks to 37.6 weeks of gestationDiagnosis of LGA with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days |
| Expectant monitoring and delivery | Active comparator | Procedure: Expectant monitoring and deliveryDiagnosis of LGA with expectant monitoring and delivery as indicated by standard obstetric practices |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Singleton pregnancy
- 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)
Key exclusion criteria (24 listed)
- Pre-gestational diabetes or gestational diabetes on medication (oral or insulin, excluding metformin)
- Planned cesarean delivery
- Polyhydramnios
- Known major fetal anomalies
- Multiple gestation or selective reduction of multiple gestation after 14 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labor induction at 37.0 weeks to 37.6 weeks of gestationDiagnosis of LGA with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days | Procedure or surgery | Labor induction at 37.0 weeks to 37.6 weeks of gestation |
| Expectant monitoring and deliveryDiagnosis of LGA with expectant monitoring and delivery as indicated by standard obstetric practices | Procedure or surgery | Expectant monitoring and delivery |
Primary outcome
Number of children presenting with CNM
Time frame: Up to 6 weeks after delivery
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.
Number of children with birthweight above 4500 grams
Time frame: Immediately at birth
3 secondary outcomes
Number of women presenting with CMM
Time frame: Up to 6 weeks after delivery
Number of children delivered by cesarean section
Time frame: Immediately at birth
Number of children admitted to NICU
Time frame: Up to 6 weeks after delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baha M Sibai, MD principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
A study testing Labor induction at 37.0 weeks to 37.6 weeks of gestation and Expectant monitoring and delivery in people with Macrosomia, Fetal and Labor Induction, run by The University of Texas Health Science Center, Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of children presenting with CNM (time frame: Up to 6 weeks after delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.