Fetal Growth RestrictionGROWNCT03046355
Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women
A study testing Labor induction at 37.0 to 37.6 weeks of gestation and Expectant monitoring until delivery in people with Fetal Growth Restriction, run by The University of Texas Health Science Center, Houston at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Fetal Growth Restriction
- What is being tested?
- Labor induction at 37.0 to 37.6 weeks of gestation and Expectant monitoring until delivery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Mar 2017to 18 Mar 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
- 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)
- FGR defined as estimated fetal weight (EFW) < 10th percentile by Hadlock formula with normal umbilical artery Doppler studies and normal amniotic fluid
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memorial Hermann Memorial City Medical Center
Houston, Texas, 77024
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Bellaire - Memorial Hermann
Houston, Texas, 77401
About this study
Official title: Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women: A Randomized Controlled Trial (GROW Trial)
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.
- Conditions
- Fetal Growth Restriction
- Being tested
- Labor induction at 37.0 to 37.6 weeks of gestation, Expectant monitoring until delivery
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labor induction at 37.0 to 37.6 weeks of gestationProcedure or surgery
Diagnosis of FGR with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days
Expectant monitoring until deliveryProcedure or surgery
Diagnosis of FGR managed with expectant monitoring and delivery as indicated
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Labor induction at 37.0 to 37.6 weeks of gestation |
| Expectant monitoring until delivery | Active comparator | Diagnosis of FGR managed with expectant monitoring and delivery as indicated Receives: Procedure: Expectant monitoring until delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately at birth
Secondary outcomes (5)
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).
Measured: 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.
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
Number of children presenting with SGA
SGA is small for gestational age when birthweight <10% for gestational age
Measured: Immediately at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start13 Mar 2017
- Primary completion18 Mar 2019
- Study completion18 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RestrictionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- NCT03046355
- Sponsor's protocol ID
- HSC-MS-16-1053
- Acronym
- GROW
- Status last verified
- Jun 2019
- First submitted
- 6 Feb 2017
- Last updated
- 13 Jun 2019
- 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 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women: A Randomized Controlled Trial (GROW Trial)
- ClinicalTrials.gov ID
- NCT03046355
- Acronym / sponsor ID
- GROW / HSC-MS-16-1053
- Conditions
- Fetal Growth Restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 8 Feb 2017 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Labor induction at 37.0 to 37.6 weeks of gestation | Experimental | Procedure: Labor induction at 37.0 to 37.6 weeks of gestationDiagnosis of FGR with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days |
| Expectant monitoring until delivery | Active comparator | Procedure: Expectant monitoring until deliveryDiagnosis of FGR managed with expectant monitoring and delivery as indicated |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Singleton pregnancy
- 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)
- FGR defined as estimated fetal weight (EFW) < 10th percentile by Hadlock formula with normal umbilical artery Doppler studies and normal amniotic fluid
Key exclusion criteria (21 listed)
- 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
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 to 37.6 weeks of gestationDiagnosis of FGR with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days | Procedure or surgery | Labor induction at 37.0 to 37.6 weeks of gestation |
| Expectant monitoring until deliveryDiagnosis of FGR managed with expectant monitoring and delivery as indicated | Procedure or surgery | Expectant monitoring until delivery |
Primary outcome
Number of children with birthweight less than the third percentile for gestational as assessed by NICHD nomograms
Time frame: Immediately at birth
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
5 secondary outcomes
Number of children presenting with CNM
Time frame: Up to 6 weeks after delivery
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
Number of children presenting with SGA
Time frame: Immediately at birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Labor induction at 37.0 to 37.6 weeks of gestation and Expectant monitoring until delivery in people with Fetal Growth Restriction, run by The University of Texas Health Science Center, Houston at 3 sites in United States.
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 5 inclusion and 21 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: finished, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 with birthweight less than the third percentile for gestational as assessed by NICHD nomograms (time frame: Immediately at birth). 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 13 Jun 2019.