NCT01369940|Completed
The NICHD Fetal Growth Study: Twin Gestations
NICHD Fetal Growth Study: Twin Gestations
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NICHD Fetal Growth Study: Twin Gestations
Sponsor study identifier
Secondary identifiers
observational
171
1 country
9
Study Start
May 29, 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 25, 2013
Actual (reported)Study Completion
September 30, 2014
Actual (reported)Normal growth and development of twins are important for the long-term health of the children. The purpose of this study was to empirically define the trajectory of fetal growth in dichorionic twins using longitudinal two-dimensional ultrasonography and to compare the fetal growth trajectories for dichorionic twins with those based on a growth standard developed by our group for singletons. This knowledge may lead to interventions that could minimize or prevent pregnancy and newborn health problems in the future.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 29, 2011
Date type not reportedThis date has not been verified as actual or estimated.
June 8, 2011
Actual (reported)June 9, 2011
Actual (reported)August 25, 2013
Actual (reported)September 30, 2014
Actual (reported)Fetal growth trajectories in dichorionic twin pregnancies
Fetal growth trajectories in dichorionic twin pregnancies were created using two- and selected three-dimensional ultrasound measures. Measures included maternal anthropometric measurements and 2D fetal biometry (BPD, HC, AC, FL) using standardized protocols. Women were recruited during the first trimester and followed until delivery. Each woman had seven scheduled ultrasound examinations, one at enrollment and six during follow-up visits. Women were randomized to receive sonograms according to one of the following two schedules: schedule A: 16, 20, 24, 28, 32 and 35 weeks or schedule B: 18, 22, 26, 30, 34 and 36 weeks.
3 years
Comparison of the fetal growth trajectories for dichorionic twins with singletons
The primary analysis compared fetal growth trajectories for dichorionic twins with 1,737 singleton gestations included in the NICHD Fetal Growth Studies - Singleton standard. For modeling twin trajectories, we used linear mixed models with a cubic spline mean structure and a random effects structure that included linear, quadratic, and cubic random effects for the twin pair and an intercept term for the individual fetus within twin pair. The linear mixed models were also used to test for overall differences (i.e., global tests) between the twin and singleton trajectories (for EFW and other measurements) using likelihood ratio tests of interaction terms between spline mean structure terms and twin-singleton indicator variables.
3 years
Body composition
3 years
Genetic and environmental factors affecting fetal growth
3 years
Biospecimen repository
3 years
Zygosity and growth trajectories
3 years
Conception mode and growth trajectories
3 years
Women with dichorionic twin gestations were enrolled between 8w0d and 13w6d and followed up to nine months (2012-2013) in this prospective cohort study. Intervention: No intervention
Women with dichorionic twin gestations, irrespective of the mode of conception, maternal medical history or obesity status, were enrolled from eight U.S. clinical centers. Women were enrolled between 8w0d and 13w6d, and accurate dating was required for enrollment. A total of 171 women were recruited, with 152 gestations resulting in live birth.
University of Alabama
Birmingham, Alabama, 35233, United States
University of California-Long Beach
Long Beach, California, 90806, United States
University of California, Irvine Medical Center
Orange, California, 92668, United States
Christiana Care Health Services
Newark, Delaware, United States
Northwestern University
Chicago, Illinois, 60611, United States
National Institute of Child Health and Human Development (NICHD), 9000 Rockville
Bethesda, Maryland, 20892, United States
Columbia University
Grantz KL, Grewal J, Albert PS, Wapner R, D'Alton ME, Sciscione A, Grobman WA, Wing DA, Owen J, Newman RB, Chien EK, Gore-Langton RE, Kim S, Zhang C, Buck Louis GM, Hediger ML. Dichorionic twin trajectories: the NICHD Fetal Growth Studies. Am J Obstet Gynecol. 2016 Aug;215(2):221.e1-221.e16. doi: 10.1016/j.ajog.2016.04.044. Epub 2016 Apr 30.
Amyx MM, Albert PS, Bever AM, Hinkle SN, Owen J, Grobman WA, Newman RB, Chien EK, Gore-Langton RE, Buck Louis GM, Grantz KL. Intrauterine growth discordance across gestation and birthweight discordance in dichorionic twins. Am J Obstet Gynecol. 2020 Feb;222(2):174.e1-174.e10. doi: 10.1016/j.ajog.2019.08.027. Epub 2019 Aug 24.
Germaine M Louis, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
171 participants (actual enrollment reported by the registry).
First Submitted
June 8, 2011
First Posted
June 9, 2011
Study Start
May 29, 2011
Date type not reportedThis date has not been verified as actual or estimated.
Incidence of fetal growth restriction (with small-for-gestational age as a proxy) in dichorionic twins (by zygosity)
Using small-for-gestational age as a proxy for growth restriction, we evaluated the percentage of dichorionic twins who would be classified below the 10th percentile using the study-generated singleton non-Hispanic white standard.
3 years
Comparison of singleton and twin gestations for maternal biomarkers of fetal growth
Longitudinal data will 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.
3 years
Contact the study team to confirm eligibility.
New York, New York, 10032-3784, United States
Women and Infants
Providence, Rhode Island, 02905, United States
Medical University of S. Carolina
Charleston, South Carolina, 29425, United States
Primary Completion
August 25, 2013
Actual (reported)Study Completion
September 30, 2014
Actual (reported)Last Updated
September 5, 2017
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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