Intrauterine Growth Restriction Clinical Trial
Official title:
The Effect of Three-dimensional Umbilical Cord Coiling Index on Obstetrical and Neonatal Outcomes: a Prospective Study
Previous studies have shown that abnormal coiling of the umbilical cord is associated with adverse perinatal outcome. For example, an umbilical cord that is non-coiled increases the chance of fetal morbidity and mortality, moreover, they have shown that the lack of the usual coiled umbilical cord configuration may result in an umbilical cord that is structurally less able to withstand external mechanical stress, on the other hand, studies from recent years show that hypercoiling - excessive coiling of the umbilical cord is associated with poor obstetric outcomes, such as fetal distress at birth, meconium staining, fetal acidosis, premature birth, intrauterine growth disorder and even fetal death. The studies carried out on the calculation of UCI include performing these measurements in two dimensions, including Doppler activation, but no studies were carried out in which three dimensions were used. The purpose of the study is to measure UCI using a 3D method in a random sample of 250 patients beyond 24 week of gestation, and to compare pregnancies with hypercoiling, hypocoiling or with a normal number of coils in terms of birth outcomes.
Status | Not yet recruiting |
Enrollment | 250 |
Est. completion date | March 1, 2026 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Singleton pregnancy - Pregnancy week > or = 24.0 Exclusion Criteria: - Twin pregnancy - Pregnancy week<24 - Single umbilical cord - Insufficient prenatal care - Abnormal anatomical fetal findings, abnormal results of aneuploidy screening - Premature rupture of membranes - Polyhydramnios or Oligohydramnios at the time of recruitment. - Intrauterine growth restriction at the time of recruitment |
Country | Name | City | State |
---|---|---|---|
Israel | Galilee Medical Center | Nahariya | Hazafon |
Lead Sponsor | Collaborator |
---|---|
Western Galilee Hospital-Nahariya |
Israel,
Chitra T, Sushanth YS, Raghavan S. Umbilical coiling index as a marker of perinatal outcome: an analytical study. Obstet Gynecol Int. 2012;2012:213689. doi: 10.1155/2012/213689. Epub 2012 Feb 14. — View Citation
de Laat MW, Franx A, van Alderen ED, Nikkels PG, Visser GH. The umbilical coiling index, a review of the literature. J Matern Fetal Neonatal Med. 2005 Feb;17(2):93-100. doi: 10.1080/14767050400028899. — View Citation
Degani S, Lewinsky RM, Berger H, Spiegel D. Sonographic estimation of umbilical coiling index and correlation with Doppler flow characteristics. Obstet Gynecol. 1995 Dec;86(6):990-3. doi: 10.1016/0029-7844(95)00307-d. — View Citation
Ma'ayeh M, McClennen E, Chamchad D, Geary M, Brest N, Gerson A. Hypercoiling of the umbilical cord in uncomplicated singleton pregnancies. J Perinat Med. 2018 Aug 28;46(6):593-598. doi: 10.1515/jpm-2017-0034. — View Citation
Machin GA, Ackerman J, Gilbert-Barness E. Abnormal umbilical cord coiling is associated with adverse perinatal outcomes. Pediatr Dev Pathol. 2000 Sep-Oct;3(5):462-71. doi: 10.1007/s100240010103. — View Citation
Rana J, Ebert GA, Kappy KA. Adverse perinatal outcome in patients with an abnormal umbilical coiling index. Obstet Gynecol. 1995 Apr;85(4):573-7. doi: 10.1016/0029-7844(94)00435-G. — View Citation
Sharma B, Bhardwaj N, Gupta S, Gupta PK, Verma A, Malviya K. Association of umbilical coiling index by colour Doppler ultrasonography at 18-22 weeks of gestation and perinatal outcome. J Obstet Gynaecol India. 2012 Dec;62(6):650-4. doi: 10.1007/s13224-012-0230-0. Epub 2012 Aug 17. — View Citation
Strong TH Jr, Elliott JP, Radin TG. Non-coiled umbilical blood vessels: a new marker for the fetus at risk. Obstet Gynecol. 1993 Mar;81(3):409-11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intrauterine growth restriction | The correlation between three-dimensional umbilical cord index and the rate of intrauterine growth restriction | 1 year | |
Secondary | Two-dimensional umbilical cord index | The correlation between three-dimensional umbilical cord index and the two-dimensional umbilical cord index | 1 year | |
Secondary | Doppler index of the umbilical cord | The correlation between three-dimensional umbilical cord index and the doppler index of the umbilical cord | 1 year | |
Secondary | fetal distress during delivery | The correlation between three-dimensional umbilical cord index and the rate of fetal distress during delivery | 2 years | |
Secondary | Meconium staining | The correlation between three-dimensional umbilical cord index and meconium staining at delivery | 2 years | |
Secondary | Delivery mode | The correlation between three-dimensional umbilical cord index and the delivery mode | 2 years | |
Secondary | Cord pH | The correlation between three-dimensional umbilical cord index and Cord pH | 2 years | |
Secondary | APGAR score | The correlation between three-dimensional umbilical cord index and APGAR score | 2 years | |
Secondary | Newborn intensive care unit admission | The correlation between three-dimensional umbilical cord index and admission to NICU | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04506970 -
Predicting Placental Pathologies by Ultrasound Imaging
|
||
Recruiting |
NCT03866863 -
Intra Uterine Growth Restriction
|
||
Recruiting |
NCT03662178 -
Investigating the Structured Use of Ultrasound Scanning for Fetal Growth
|
||
Not yet recruiting |
NCT05720169 -
Fetal, Obstetrics and Reproduction Genomics
|
||
Completed |
NCT04633551 -
Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes
|
N/A | |
Recruiting |
NCT05500989 -
PlacEntal Acute Atherosis RefLecting Subclinical Atherosclerosis
|
||
Recruiting |
NCT04141189 -
Comparison of Follow-up Protocols in Terms of Fetal, Neonatal and Maternal Results in Intrauterine Growth Retardation
|
N/A | |
Completed |
NCT03726697 -
Effect of Tahneek on Hypoglycemia in Newborn Infants
|
N/A | |
Recruiting |
NCT03398629 -
Diagnosis and Management of Intrauterine Growth Restriction and Congenital Anomalies
|
||
Recruiting |
NCT02473991 -
Correlation Between Placental Thickness in the Second and Third Trimester and Fetal Weight
|
N/A | |
Completed |
NCT02696577 -
The Effect of Omega 3 on Pregnancy Complicated by Asymmetrical Intrauterine Growth Restriction
|
Phase 2 | |
Recruiting |
NCT04766866 -
sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term.
|
N/A | |
Terminated |
NCT04047966 -
Study of the Fetal and Maternal Microbiota in Preganant Women With Fetal Defect Growth
|
||
Not yet recruiting |
NCT03865628 -
Ultrasound Evaluation of Fetal Hemodynamics and Perinatal Complications
|
||
Completed |
NCT05328453 -
Sonographic 3D Measurement of Fetal Thymus May be Used to Predict the Small Baby in Pregnancy.
|
||
Completed |
NCT05800938 -
The Effect of Oral Isosorbide Mononitrate Therapy on Umbilical Artery Doppler Resistance Index in Pregnancies With Intrauterine Growth Restriction: Prospective Randomized Control Trial
|
Phase 4 | |
Not yet recruiting |
NCT06226051 -
Growing Little PEAPODS Study
|
||
Recruiting |
NCT02807324 -
Women Specific Cardiac Recovery After Preeclampsia
|
||
Recruiting |
NCT02515292 -
Evaluation of Infants With Intrauterine Growth Restriction
|
N/A | |
Active, not recruiting |
NCT01942525 -
Influence of Intrauterine Growth Restriction on Amplitude-integrated EEG in Preterm Infants
|
N/A |