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The Value of Prenatal Ultrasound in Complicated Twin Pregnancy and Its Correlation With Chromosomal Anomalies

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ClinicalTrials.gov Identifier: NCT02732717
Recruitment Status : Unknown
Verified December 2015 by First Affiliated Hospital Xi'an Jiaotong University.
Recruitment status was:  Not yet recruiting
First Posted : April 11, 2016
Last Update Posted : April 11, 2016
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Brief Summary:

Recent years, women with infertility have become more and more and thus assisted reproductive technology has been applied in a broad range. And the quantities of twin pregnancies are larger and larger. However, complicated twin pregnancy subsequently increased including selective intrauterine growth restriction (sIUGR), twin growth discordance, twin transfusion syndrome (TTTS) and intrauterine fetal death (IUFD). The occurrence of complicated twin pregnancy has been the leading cause of morbidity and mortality in twin and mother. Meanwhile, twin pregnancy, especially monochorionic type has suffered from higher rate of chromosomal anomalies and structural anomalies. Therefore, it is important that more attention should be paid to the prediction, clinical evaluation and the occurrence of chromosomal anomalies and structural anomalies in complicated twin pregnancy.

So far, prenatal ultrasound has been acknowledged as the best method for prenatal diagnosis and evaluation in twin pregnancy. By means of the application of prenatal ultrasound, the detection of fetal chromosome, and secondary correlation analysis, the investigators try to build prenatal ultrasound monitoring system of twin pregnancy and provide evidences for the choice of intervention and delivery time, in order to decrease the morbidity and mortality of twin and improve perinatal short and long outcomes.

The goals of this study are as below: (1) primary goal: the prediction of complicated twin pregnancy by using prenatal ultrasound; (2) primary goal: the clinical evaluation of perinatal outcomes in twin pregnancy by using prenatal ultrasound; (3) secondary goal: the analysis of the correlation between prenatal ultrasound and fetal anomalies.


Condition or disease Intervention/treatment
Complicated Twin Pregnancy Other: ultrasound (observation)

Detailed Description:

The study is designed as an observational prospective cohort study. The primary outcome is complicated twin pregnancy (sIUGR, TTTS, IUFD, twin growth discordance). The main exposed factors are discordance of crown-rump length more than 20%, discordance of nuchal translucency more than 20%, either of twin with abnormal amniotic fluid (polyhydramnios or oligoamnios), either of twin with abnormal umbilical artery flow (elevated resistance index, absent or reverse diastolic flow), either of twin with abnormal middle cerebral artery flow (more than 1.5Mom), either of twin with abnormal ductus venous flow (absent or reverse a-wave). Meanwhile, some demographic data are to be collected and confounding factors are to be analyzed.

Women with twin pregnancy who are examined in the department are enrolled in this study. Ultrasound will be done in 11-13+6 weeks, 16-18 weeks, 22-24 weeks, 30-32 weeks and 37-39 weeks, and perinatal outcomes are to be collected, including the diagnosis of complicated twin pregnancy, when it happens, ultrasound indices, delivery mode, delivery time, birth weight, neonatal outcomes.

When there are indications for the detection of fetal chromosome, women are probably advised to have this examination, such as non-invasive DNA, amniocentesis, umbilical cord screening, as appropriate, and written informed consent will be achieved from every patient.


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Study Type : Observational
Estimated Enrollment : 580 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Value of Prenatal Ultrasound in the Diagnosis and Monitoring of Complicated Twin Pregnancy and Its Correlation With Chromosomal Anomalies of Twin
Study Start Date : April 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
abnormal ultrasound index
twin pregnancy with abnormal ultrasound index
Other: ultrasound (observation)

Important sonographic indices are to be collected from 11-14 weeks, 16-18 weeks, 22-24 weeks, 30-32 weeks and 37-39 weeks,including crown-rump length, nuchal translucency, amniotic fluid, umbilical artery flow, middle cerebral artery flow,ductus venous flow. It is observational.

Conditions as below are thought abnormal: discordance of crown-rump length more than 20%, discordance of nuchal translucency more than 20%, either of twin with abnormal amniotic fluid (polyhydramnios or oligoamnios), either of twin with abnormal umbilical artery flow (elevated resistance index, absent or reverse diastolic flow), either of twin with abnormal middle cerebral artery flow (more than 1.5Mom), either of twin with abnormal ductus venous flow (absent or reverse a-wave).


normal ultrasound index
twin pregnancy with normal ultrasound index
Other: ultrasound (observation)

Important sonographic indices are to be collected from 11-14 weeks, 16-18 weeks, 22-24 weeks, 30-32 weeks and 37-39 weeks,including crown-rump length, nuchal translucency, amniotic fluid, umbilical artery flow, middle cerebral artery flow,ductus venous flow. It is observational.

Conditions as below are thought abnormal: discordance of crown-rump length more than 20%, discordance of nuchal translucency more than 20%, either of twin with abnormal amniotic fluid (polyhydramnios or oligoamnios), either of twin with abnormal umbilical artery flow (elevated resistance index, absent or reverse diastolic flow), either of twin with abnormal middle cerebral artery flow (more than 1.5Mom), either of twin with abnormal ductus venous flow (absent or reverse a-wave).





Primary Outcome Measures :
  1. the occurrence of complicated twin pregnancy as assessed by prenatal ultrasound [ Time Frame: up to two years ]
    It is referred to the occurrence of at least one situation described as below. sIUGR is defined as one fetus with birth weight<the 10th percentile for gestational age and the discordance of intertwin weight is more than 20%; twin growth discordance is defined as the discordance of intertwin weight is more than 20%; TTTS:Stage I-discordant amnionic fluid volumes described as one fetus with polyhydramnios (maximum vertical pocket≥8cm) and the other fetus with oligoamnios (maximum vertical pocket<2cm), but urine is visible in the bladder of donor twin.Stage II-criteria of stage I, but urine is not visible in donor bladder.Stage III-criteria of stage II and abnormal Doppler studies of the umbilical artery, ductus venosus or umbilical vein. Stage IV-ascites or frank hydrops in either twin. Stage V—demise of either fetus;IUFD is referred to the death of twins in the uterine.


Secondary Outcome Measures :
  1. without occurrence of complicated twin pregnancy as assessed by prenatal ultrasound [ Time Frame: up to two years ]
    It is referred to no occurrence of any situation described as below. sIUGR is defined as one fetus with birth weight<the 10th percentile for gestational age and the discordance of intertwin weight is more than 20%; twin growth discordance is defined as the discordance of intertwin weight is more than 20%; TTTS:Stage I-discordant amnionic fluid volumes described as one fetus with polyhydramnios (maximum vertical pocket≥8cm) and the other fetus with oligoamnios (maximum vertical pocket<2cm), but urine is visible in the bladder of donor twin.Stage II-criteria of stage I, but urine is not visible in donor bladder.Stage III-criteria of stage II and abnormal Doppler studies of the umbilical artery, ductus venosus or umbilical vein. Stage IV-ascites or frank hydrops in either twin. Stage V—demise of either fetus;IUFD is referred to the death of twins in the uterine.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
pregnant women who visit the First Affiliated Hospital of Xian Jiaotong University.
Criteria

Inclusion Criteria:

  • women with twin pregnancy starting at 11-14 weeks of gestation.

Exclusion Criteria:

  • women with triplet pregnancy;
  • complicating with acute internal or surgical diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732717


Contacts
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Contact: Zhen Han, Phd 0086-13891914781 y.t.1109@qq.com

Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Study Chair: Zhen Han, Phd First Affiliated Hospital of Xian Jiaotong University

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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02732717     History of Changes
Other Study ID Numbers: XJTU1AF-CRS-2015-003
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: April 11, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Chromosome Disorders
Chromosome Aberrations
Congenital Abnormalities
Pathologic Processes
Genetic Diseases, Inborn