Condition of Fetal Growth or Malnutrition (Diagnosis)NCT03200665
Sonographic Evaluation of Fetal Growth in the Third Trimester of Low-risk Pregnancy: a Randomized Trial
A study testing Ultrasound 35-36 (6 / 7 days weeks) in people with Condition of Fetal Growth or Malnutrition (Diagnosis), run by Hospital de Santa Maria, Portugal at 1 site in Portugal.
Trial summary
Sonographic fetal weight estimation at the last weeks of third trimester in low-risk pregnancies is an effective method for diagnosis of fetal growth restriction (FGR) permitting close surveillance and timely delivery. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Condition of Fetal Growth or Malnutrition (Diagnosis)
- What is being tested?
- Ultrasound 35-36 (6 / 7 days weeks)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,093 participants
- Where
- 1 sitePortugal
- Study dates
- Jul 2015to Jan 2020
- 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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Single fetus pregnancy
Who cannot join
- Diabetes
- Hypertension
- Pre-eclampsia
- Autoimmune diseases
- Antecedent of fetal growth restriction or pre-eclampsia
- Placental anomalies
Show all 9Show fewer
- Fetal malformations
- Chromosome anomalies
- TORCH Infections
Trial locations and contacts
1 site in 1 country.
About this study
Sonographic fetal weight estimation at the last weeks of third trimester in low-risk pregnancies is an effective method for diagnosis of fetal growth restriction (FGR) permitting close surveillance and timely delivery. The need for a systematic ultrasound evaluation at the last weeks of a low-risk pregnancy and the best time to perform it remains controversial. The most commonly used clinical screening tool in this population is the serial measurement of symphysis-fundus distance, which is a method of a variable and low sensitivity for detection of FGR.
In Portugal, in accordance with guidelines of Direcção Geral de Saúde from 2015, fetal growth restriction screening in low risk pregnancies is performed with an ultrasound for fetal weight estimation at 30th-33rd weeks. Nonetheless, recent data from randomized trials showed that FGR detection rate was superior at 36 vs 32 weeks' gestation. In cases of severe FGR, detection rate was also superior at 36 vs 32 weeks' gestation. In a prior retrospective study, our group analyzed 1429 term low risk pregnancies and the investigators concluded that small for gestational age term babies (birthweight < 10th centile) had a statistically significant higher rate of operative deliveries for intrapartum fetal distress than appropriate for gestational age as well as a higher rate of admission to neonatal intensive care unit. Moreover the investigators compared the same outcomes within small for gestational age neonates with antepartum detection at 30th-33rd weeks ultrasound vs undetected (normal 30th-33rd weeks ultrasound). Antepartum detection of small for gestational age neonates showed a statistically significant lower rate of operative deliveries for intrapartum fetal distress than undetected small for gestational age neonates. The investigators will conduct a prospective randomized clinical trial with the aim to evaluate if a 35th-37th weeks after the standard of care ultrasound in low risk pregnancies is effective in improving the detection rate of FGR and in reducing cesarean deliveries for intrapartum fetal distress and admission to neonatal intensive care unit.
Read the detailed description
The population to include in this study corresponds to the low-risk pregnant women with surveillance at the Prenatal Consultation or referenced by the Primary Care units to the Department of Obstetrics \& Gynecology of Hospital de Santa Maria. The screening method for detection of fetuses at risk of fetal growth restriction currently used in low-risk pregnancies is the measurement of the symphysis-uterine distal distance at all visits from 24 weeks and a third trimester ultrasound at 30-32 (6 / 7 days weeks).
The patients who agree to participate in the study, after signing an informed consent, will be randomized into 2 groups (with and without an additional ultrasound evaluation at 35-35+6 (6 / 7 days weeks)). The randomization will be done through computer software.
Clinical data will be recorded such as: maternal age, ethnicity, parity, height, weight, socioeconomic status and smoking habits.
In the study group (ultrasound evaluation at 35-35+6 (6 / 7 days weeks)), the ultrasound evaluation will include biometric parameters of the fetus: cephalic perimeter, biparietal diameter, abdominal circumference and femur length. Based on these measurements, the computer system (Astraia) provides the estimated fetal weight and respective percentile according to the Hadlock formula. Amniotic fluid will also be measured (maximum column). Functional evaluation will include: Doppler of the umbilical artery, middle cerebral artery and Uterine arteries. The respective index of pulsatility and cerebroplacental ratio will be registered. All Doppler evaluations will be performed in the absence of somatic and respiratory fetal movements, under transitory maternal apnea, with the lowest insonation angle possible and at least 3 successive complexes will be evaluated for each measurement.
Obstetric and neonatal outcomes will be registered after delivery by revising medical records such as: gestational age at delivery, prepartum hemoglobin, type of labor (spontaneous or induced and respective indication), type of delivery (eutocic, instrumental, antepartum or intrapartum cesarean section), indication of instrumental or cesarean delivery, cardiotocographic register characteristics (repeated severe variable decelerations, late decelerations, absence of variability), evidence of meconial fluid, neonatal morbidity (hypoglycemia, hypothermia, transient tachypnea, hyperbilirubinemia requiring phototherapy, meconium aspiration syndrome, admission to neonatal intensive care unit, metabolic acidosis, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, seizures and asphyxia) and mortality.
Sample size calculation
According to a retrospective analysis performed in the target population of this study, the rate of intrapartum fetal hypoxia requiring obstetric intervention in pregnant women with fetal growth restriction is 28%. Aiming to reduce this adverse perinatal outcome by 10%, it is estimated that the investigators will need to include a total sample of 2700 pregnant women (1350 in each group), with 80% power and α level of 0.05.
Performing third-trimester ultrasound at 30-32 weeks, the rate of antenatal detection of fetal growth restriction is 20.5% in low risk pregnancies. Aiming to increase the detection rate by at least 7%, the investigators will require a total sample of 1,200 pregnant women (600 in each group), with 80% power and α level of 0.05. Thus an interim analysis is expected to be performed when 1200 cases are recruited to the study to compare the detection rate of fetal growth restriction between the two groups.
- Being tested
- Ultrasound 35-36 (6 / 7 days weeks)
- Medical subject headings
- Malnutrition, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound 35-36 (6 / 7 days weeks)Diagnostic test
An obstetric ultrasound will be performed at 35-36 (6 / 7 days weeks) including biometric parameters and functional parameters of the fetus
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound 35-36 (6 / 7 days weeks) | Experimental | The patients that are randomized to this group, besides accomplishing the standard of care of national guidelines (third trimester ultrasound at 30-32 (6 / 7 days weeks)) will be submitted to an additional third trimester ultrasound at 35-36 (6 / 7 days weeks). Receives: Diagnostic Test: Ultrasound 35-36 (6 / 7 days weeks) |
| Standard of Care | No intervention | This is the control group that will be managed in accordance to national guidelines of screening of late fetal growth restriction in low risk pregnancies: third trimester ultrasound at 30-32 (6 / 7 days weeks). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To increase the detection rate of late fetal growth restriction in low risk pregnancies
Diagnosis of fetal growth restriction is defined as birthweight under 10th centile according to gestational age
Measured: It will be assessed when the baby is delivered (about 5 weeks after intervention) by comparing antenatal fetal weight estimation centiles of both ultrasounds with birthweight centiles and evaluate which ultrasound is more accurate
Secondary outcomes (1)
To decrease the rate of cesarean and instrumental deliveries indicated by intrapartum hypoxia
Intrapartum hypoxia will be defined by interpreting continuous cardiotocographic monitoring during labor.
Measured: It will be assessed after delivery (about 5 weeks after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study startJul 2015
- Primary completionNov 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condition of Fetal Growth or Malnutrition (Diagnosis)Studies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,093 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Santa Maria, Portugal
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Catarina Policiano, Hospital de Santa Maria, Portugal
- Investigators
- Catarina Policiano, Principal investigator, CHLN, Hospital de Santa Maria. Faculdade de Medicina da Universidade de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200665
- Sponsor's protocol ID
- FCTUltrasoundIUGR
- Status last verified
- Jan 2020
- First submitted
- 24 Jun 2017
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Evaluation of Fetal Growth in the Third Trimester of Low-risk Pregnancy: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03200665
- Acronym / sponsor ID
- FCTUltrasoundIUGR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,093 participants (actual)
- Lead sponsor
- Hospital de Santa Maria, PortugalUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- Jul 2015 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 27 Jun 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.
Sonographic fetal weight estimation at the last weeks of third trimester in low-risk pregnancies is an effective method for diagnosis of fetal growth restriction (FGR) permitting close surveillance and timely delivery. The need for a systematic ultrasound evaluation at the last weeks of a low-risk pregnancy and the best time to perform it remains controversial. The most commonly used clinical screening tool in this population is the serial measurement of symphysis-fundus distance, which is a method of a variable and low sensitivity for detection of FGR.
In Portugal, in accordance with guidelines of Direcção Geral de Saúde from 2015, fetal growth restriction screening in low risk pregnancies is performed with an ultrasound for fetal weight estimation at 30th-33rd weeks. Nonetheless, recent data from randomized trials showed that FGR detection rate was superior at 36 vs 32 weeks' gestation. In cases of severe FGR, detection rate was also superior at 36 vs 32 weeks' gestation. In a prior retrospective study, our group analyzed 1429 term low risk pregnancies and the investigators concluded that small for gestational age term babies (birthweight < 10th centile) had a statistically significant higher rate of operative deliveries for intrapartum fetal distress than appropriate for gestational age as well as a higher rate of admission to neonatal intensive care unit. Moreover the investigators compared the same outcomes within small for gestational age neonates with antepartum detection at 30th-33rd weeks ultrasound vs undetected (normal 30th-33rd weeks ultrasound). Antepartum detection of small for gestational age neonates showed a statistically significant lower rate of operative deliveries for intrapartum fetal distress than undetected small for gestational age neonates. The investigators will conduct a prospective randomized clinical trial with the aim to evaluate if a 35th-37th weeks after the standard of care ultrasound in low risk pregnancies is effective in improving the detection rate of FGR and in reducing cesarean deliveries for intrapartum fetal distress and admission to neonatal intensive care unit.
Detailed description
The population to include in this study corresponds to the low-risk pregnant women with surveillance at the Prenatal Consultation or referenced by the Primary Care units to the Department of Obstetrics \& Gynecology of Hospital de Santa Maria. The screening method for detection of fetuses at risk of fetal growth restriction currently used in low-risk pregnancies is the measurement of the symphysis-uterine distal distance at all visits from 24 weeks and a third trimester ultrasound at 30-32 (6 / 7 days weeks).
The patients who agree to participate in the study, after signing an informed consent, will be randomized into 2 groups (with and without an additional ultrasound evaluation at 35-35+6 (6 / 7 days weeks)). The randomization will be done through computer software.
Clinical data will be recorded such as: maternal age, ethnicity, parity, height, weight, socioeconomic status and smoking habits.
In the study group (ultrasound evaluation at 35-35+6 (6 / 7 days weeks)), the ultrasound evaluation will include biometric parameters of the fetus: cephalic perimeter, biparietal diameter, abdominal circumference and femur length. Based on these measurements, the computer system (Astraia) provides the estimated fetal weight and respective percentile according to the Hadlock formula. Amniotic fluid will also be measured (maximum column). Functional evaluation will include: Doppler of the umbilical artery, middle cerebral artery and Uterine arteries. The respective index of pulsatility and cerebroplacental ratio will be registered. All Doppler evaluations will be performed in the absence of somatic and respiratory fetal movements, under transitory maternal apnea, with the lowest insonation angle possible and at least 3 successive complexes will be evaluated for each measurement.
Obstetric and neonatal outcomes will be registered after delivery by revising medical records such as: gestational age at delivery, prepartum hemoglobin, type of labor (spontaneous or induced and respective indication), type of delivery (eutocic, instrumental, antepartum or intrapartum cesarean section), indication of instrumental or cesarean delivery, cardiotocographic register characteristics (repeated severe variable decelerations, late decelerations, absence of variability), evidence of meconial fluid, neonatal morbidity (hypoglycemia, hypothermia, transient tachypnea, hyperbilirubinemia requiring phototherapy, meconium aspiration syndrome, admission to neonatal intensive care unit, metabolic acidosis, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, seizures and asphyxia) and mortality.
Sample size calculation
According to a retrospective analysis performed in the target population of this study, the rate of intrapartum fetal hypoxia requiring obstetric intervention in pregnant women with fetal growth restriction is 28%. Aiming to reduce this adverse perinatal outcome by 10%, it is estimated that the investigators will need to include a total sample of 2700 pregnant women (1350 in each group), with 80% power and α level of 0.05.
Performing third-trimester ultrasound at 30-32 weeks, the rate of antenatal detection of fetal growth restriction is 20.5% in low risk pregnancies. Aiming to increase the detection rate by at least 7%, the investigators will require a total sample of 1,200 pregnant women (600 in each group), with 80% power and α level of 0.05. Thus an interim analysis is expected to be performed when 1200 cases are recruited to the study to compare the detection rate of fetal growth restriction between the two groups.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound 35-36 (6 / 7 days weeks) | Experimental | Diagnostic Test: Ultrasound 35-36 (6 / 7 days weeks)The patients that are randomized to this group, besides accomplishing the standard of care of national guidelines (third trimester ultrasound at 30-32 (6 / 7 days weeks)) will be submitted to an additional third trimester ultrasound at 35-36 (6 / 7 days weeks). |
| Standard of Care | No intervention | –This is the control group that will be managed in accordance to national guidelines of screening of late fetal growth restriction in low risk pregnancies: third trimester ultrasound at 30-32 (6 / 7 days weeks). |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Single fetus pregnancy
Key exclusion criteria (9 listed)
- Diabetes
- Hypertension
- Pre-eclampsia
- Autoimmune diseases
- Antecedent of fetal growth restriction or pre-eclampsia
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 |
|---|---|---|
| Ultrasound 35-36 (6 / 7 days weeks)An obstetric ultrasound will be performed at 35-36 (6 / 7 days weeks) including biometric parameters and functional parameters of the fetus | Diagnostic test | Ultrasound 35-36 (6 / 7 days weeks) |
Primary outcome
To increase the detection rate of late fetal growth restriction in low risk pregnancies
Time frame: It will be assessed when the baby is delivered (about 5 weeks after intervention) by comparing antenatal fetal weight estimation centiles of both ultrasounds with birthweight centiles and evaluate which ultrasound is more accurate
Diagnosis of fetal growth restriction is defined as birthweight under 10th centile according to gestational age
1 secondary outcome
To decrease the rate of cesarean and instrumental deliveries indicated by intrapartum hypoxia
Time frame: It will be assessed after delivery (about 5 weeks after intervention)
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 21 Jan 2020.
- Individual participant dataSharing planned: Undecided
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.
Catarina Policiano principal investigator
CHLN, Hospital de Santa Maria. Faculdade de Medicina da Universidade de Lisboa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound 35-36 (6 / 7 days weeks) in people with Condition of Fetal Growth or Malnutrition (Diagnosis), run by Hospital de Santa Maria, Portugal at 1 site in Portugal.
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 1 inclusion and 9 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 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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?
To increase the detection rate of late fetal growth restriction in low risk pregnancies (time frame: It will be assessed when the baby is delivered (about 5 weeks after intervention) by comparing antenatal fetal weight estimation centiles of both ultrasounds with birthweight centiles and evaluate which ultrasound is more accurate). 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 21 Jan 2020.