The NICHD Fetal Growth Study: Twin Gestations
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 8/4/2017 |
| Start Date: | May 29, 2011 |
| End Date: | August 1, 2017 |
NICHD Fetal Growth Study: Twin Gestations
Background:
-Normal growth and development of twins are important for a healthy pregnancy and the
long-term health of the children. This study will look at how twins grow and develop inside
the womb. This knowledge may reduce and/or prevent pregnancy and newborn health problems in
the future.
Objective:
-To describe how twins grow.
To describe how identical (from the same egg) and fraternal (from different eggs) twins grow.
- To compare growth patterns between twin and single pregnancies.
- To find out how many babies have growth problems and why they have them.
Eligibility:
-Women from nine U.S. clinical centers who are in the first three months of a twin pregnancy.
Design:
- Participants will answer questions about personal characteristics (age, education,
race). They will also answer questions about pregnancy history, health behavior, and
their environment. This will take about 30 minutes. They will also fill out a
questionnaire about physical activity, and mood and depression. An ultrasound will be
done to check on the babies measurements.
- Participants will return for six visits during their pregnancy. Each follow-up will
include an ultrasound and a test to measure the length of the cervix. We will ask
questions about health and any events or symptoms since the visit before. We will also
take body measurements.
- A nutrition questionnaire will be completed at the first visit and at follow-up visits 2
and 5.
- Blood will be drawn at the beginning of the study, at three follow-up visits, and just
before delivery.
- When the babies are born, they will have placenta and cord blood samples, measurements,
and swabs from the inside of the mouth.
-Normal growth and development of twins are important for a healthy pregnancy and the
long-term health of the children. This study will look at how twins grow and develop inside
the womb. This knowledge may reduce and/or prevent pregnancy and newborn health problems in
the future.
Objective:
-To describe how twins grow.
To describe how identical (from the same egg) and fraternal (from different eggs) twins grow.
- To compare growth patterns between twin and single pregnancies.
- To find out how many babies have growth problems and why they have them.
Eligibility:
-Women from nine U.S. clinical centers who are in the first three months of a twin pregnancy.
Design:
- Participants will answer questions about personal characteristics (age, education,
race). They will also answer questions about pregnancy history, health behavior, and
their environment. This will take about 30 minutes. They will also fill out a
questionnaire about physical activity, and mood and depression. An ultrasound will be
done to check on the babies measurements.
- Participants will return for six visits during their pregnancy. Each follow-up will
include an ultrasound and a test to measure the length of the cervix. We will ask
questions about health and any events or symptoms since the visit before. We will also
take body measurements.
- A nutrition questionnaire will be completed at the first visit and at follow-up visits 2
and 5.
- Blood will be drawn at the beginning of the study, at three follow-up visits, and just
before delivery.
- When the babies are born, they will have placenta and cord blood samples, measurements,
and swabs from the inside of the mouth.
Fetal growth is an important determinant of health and disease in the perinatal period,
childhood and adult life. NICHD is conducting an ultrasound study in singleton pregnancies to
establish a national standard for normal fetal growth by gestation and interval velocities.
Twins represent 3.2% of all births in the U.S, and these pregnancies are at increased risk
for fetal growth disorders, preterm and, most importantly, very preterm delivery. The rate of
small-for-gestational-age (SGA) defined as below the 10th percentile using a singleton birth
weight-for-gestational-age reference is 35%. Neonatal morbidity is higher in twin gestations
than in singletons (25.6 versus 4 per 1,000), and the infant mortality rate is also higher
(31 versus 6.4 per 1,000). Discrepancy in the sizes of twins at birth is a frequent
phenomenon, and is associated with an increased risk of perinatal morbidity and mortality.
The trajectory of fetal growth in twins throughout gestation has been observed and described
in a few studies, both using ultrasonography and ultrasonography combined with birth weight.
The findings suggest a slowing of growth for almost all twins after 28-30 weeks gestation,
and even twins who had been growing at rates similar to singletons before 28 weeks may show
slowed rates of growth in the third trimester. It has been hypothesized that this pattern of
growth for even well-growing twins is a normal down-regulation in response to a constricted
uterine environment and may underscore the need for a birth weight-for-gestational-age or
ultrasound reference that is specific for twins. As for singleton births, however, such
slow-downs later in pregnancy appear to be associated with earlier delivery and a greater
risk for morbidity associated with preterm birth. This would argue against a separate
reference for twins or, at least, for the development of a growth velocity standard for
singletons and twins to allow for the accurate assessment of interval growth to better manage
these cases.
We propose to conduct the NICHD Fetal Growth Study Twin Gestations, which is a prospective
cohort study with longitudinal measurement of fetal growth conducted in nine clinical
centers. Overall, there are four main research objectives: 1) to describe fetal growth
trajectories in twins using two- and selected three-dimensional ultrasound measures; 2) to
compare and contrast fetal growth trajectories for twins with the newly established fetal
growth standard developed for singletons to determine its applicability for monitoring the
growth of twin fetuses and discordant growth of the pair; 3) to estimate the incidence of
growth restriction (with SGA as a proxy) in singleton and twin gestations (by zygosity),
however, growth restriction may be defined by the new growth standard; and 4) to compare
singleton and twin gestations with respect to maternal biomarkers of fetal growth, well-being
and maternal nutritional status using banked biospecimens to determine if the biomarkers
ranges established for singletons are applicable to twin gestations.
This study will recruit 350 pregnant women with a twin gestation from nine clinical centers.
The study is designed to enroll approximately 350 dichorionic twin pairs based upon incidence
figures for twinning at the population level. Women will be recruited during the first
trimester and followed until delivery. Serial ultrasound assessments of fetal growth are the
standard of care for twin pregnancies, and we will coordinate the timing of research
ultrasounds to the fullest extent possible with clinical scans to minimize exposure as
further described in this protocol. Each woman will have seven scheduled ultrasound
examinations, including fetal biometry at all visits, fetal Doppler studies, and four blood
draws at baseline and at targeted gestational ages for the eventual identification of
biomarkers indicative of fetal growth. After delivery, neonatal anthropometric measures will
be assessed for each twin, and select information about the obstetrical course and newborn
status will be abstracted from medical charts.
childhood and adult life. NICHD is conducting an ultrasound study in singleton pregnancies to
establish a national standard for normal fetal growth by gestation and interval velocities.
Twins represent 3.2% of all births in the U.S, and these pregnancies are at increased risk
for fetal growth disorders, preterm and, most importantly, very preterm delivery. The rate of
small-for-gestational-age (SGA) defined as below the 10th percentile using a singleton birth
weight-for-gestational-age reference is 35%. Neonatal morbidity is higher in twin gestations
than in singletons (25.6 versus 4 per 1,000), and the infant mortality rate is also higher
(31 versus 6.4 per 1,000). Discrepancy in the sizes of twins at birth is a frequent
phenomenon, and is associated with an increased risk of perinatal morbidity and mortality.
The trajectory of fetal growth in twins throughout gestation has been observed and described
in a few studies, both using ultrasonography and ultrasonography combined with birth weight.
The findings suggest a slowing of growth for almost all twins after 28-30 weeks gestation,
and even twins who had been growing at rates similar to singletons before 28 weeks may show
slowed rates of growth in the third trimester. It has been hypothesized that this pattern of
growth for even well-growing twins is a normal down-regulation in response to a constricted
uterine environment and may underscore the need for a birth weight-for-gestational-age or
ultrasound reference that is specific for twins. As for singleton births, however, such
slow-downs later in pregnancy appear to be associated with earlier delivery and a greater
risk for morbidity associated with preterm birth. This would argue against a separate
reference for twins or, at least, for the development of a growth velocity standard for
singletons and twins to allow for the accurate assessment of interval growth to better manage
these cases.
We propose to conduct the NICHD Fetal Growth Study Twin Gestations, which is a prospective
cohort study with longitudinal measurement of fetal growth conducted in nine clinical
centers. Overall, there are four main research objectives: 1) to describe fetal growth
trajectories in twins using two- and selected three-dimensional ultrasound measures; 2) to
compare and contrast fetal growth trajectories for twins with the newly established fetal
growth standard developed for singletons to determine its applicability for monitoring the
growth of twin fetuses and discordant growth of the pair; 3) to estimate the incidence of
growth restriction (with SGA as a proxy) in singleton and twin gestations (by zygosity),
however, growth restriction may be defined by the new growth standard; and 4) to compare
singleton and twin gestations with respect to maternal biomarkers of fetal growth, well-being
and maternal nutritional status using banked biospecimens to determine if the biomarkers
ranges established for singletons are applicable to twin gestations.
This study will recruit 350 pregnant women with a twin gestation from nine clinical centers.
The study is designed to enroll approximately 350 dichorionic twin pairs based upon incidence
figures for twinning at the population level. Women will be recruited during the first
trimester and followed until delivery. Serial ultrasound assessments of fetal growth are the
standard of care for twin pregnancies, and we will coordinate the timing of research
ultrasounds to the fullest extent possible with clinical scans to minimize exposure as
further described in this protocol. Each woman will have seven scheduled ultrasound
examinations, including fetal biometry at all visits, fetal Doppler studies, and four blood
draws at baseline and at targeted gestational ages for the eventual identification of
biomarkers indicative of fetal growth. After delivery, neonatal anthropometric measures will
be assessed for each twin, and select information about the obstetrical course and newborn
status will be abstracted from medical charts.
- INCLUSION CRITERIA:
- Twin, viable pregnancy
- 8+0 13+6 weeks of gestation
- Maternal age 18 45 years
- Spontaneous pregnancy or pregnancy from ovulation induction or in-vitro fertilization
with known date of transfer
- Pregnancy from egg donor or embryo donor (record if anonymous or known source)
- LMP-date and crown-rump length measurement match within certain number of days
according to a standard scheme (for larger
twin)
- Expect to deliver at one of the participating hospitals
EXCLUSION CRITERIA:
- Fetal reduction (medically induced only)
- Congenital anomalies (structural or chromosomal)
- Either twin with an increased nuchal translucency (>99th percentile for crown-rump
length; i.e. 3.5 mm or more)
- Monochorionic twins
- Crown-rump length discordancy >10% in dichorionic twin pregnancies74
We found this trial at
9
sites
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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Bethesda, Maryland 20892
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101 The City Drive South
Orange, California 92868
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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