Clinical Trials Logo

Clinical Trial Summary

: In this Prospective longitudinal observational study, two hundred pregnant women with singleton pregnancy from 11 up to 13 weeks with history of intrauterine growth restriction in a previous pregnancy underwent ultrasound assessment of gestational age , ultrasound assessment of uterine artery pulsatility index, placental volume by 3D ultrasound and placental vascularization by 3D power Doppler (3DPD).


Clinical Trial Description

This Prospective longitudinal observational study was conducted at Benha University hospital starting from December 2016 to May 2019 after approval of faculty Research Ethics Board. Two hundred pregnant women with history of IUGR in previous pregnancy were recruited for the study after full explanation of the method, aim of work and obtaining consent. Inclusion criteria: singleton pregnancy from 11 up to 13 weeks. History of intrauterine growth restriction in previous pregnancy Exclusion criteria: Multiple pregnancies, Smoking women, and pre-existing medical disorders which may affect fetal growth e.g. hypertension, diabetes mellitus, thyroid dysfunction or renal impairment. Ultrasound evidence of congenital anomalies.

All women underwent ultrasound study which was performed by a member of ultra-sound unit (Volsun 730 pro V; G.E medical system), for assessment of: Gestational age confirmed by crown-rump length assessment, Uterine artery pulsatility index (angle of insonation is<50°, the sampling gate set at 2mm), 3D ultrasound assessment of Placental volume, 3DPD for assessment of placental vascularization. The examination was done with the patient in lithotomy position with slight left lateral tilting to avoid supine hypotension.

After visualization of the placental vasculature, 3D static power Doppler scanning was performed. After scanning the region of interest, placental volume was measured using the VOCAL rotational technique and VOCAL software (3D Sono View, GE Medical Systems, Milwaukee, WI, USA). After completing a full rotation, another analysis was performed using VOCAL Software (3D Sono View, GE Medical Systems, Milwaukee, WI, USA), which automatically calculates placental volume, vascularization index (VI), flow index (FI) and vascularization flow index(VFI). Low dose aspirin 75mg was described for all cases with the beginning of 2nd trimester.

All cases were having a second (between 20 to 24 weeks) and a third ultrasound assessment for exclusion of congenital malformation and assessment of fetal growth parameter and identification of IUGR cases (according to fetal growth curves). (Nicolaides KH et al., 2018). In order to avoid including healthy, yet constitutionally small for gestational age fetuses to the IUGR group, patients' data were included in the study only in cases of IUGR diagnosis confirmed after delivery. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04399174
Study type Observational
Source Benha University
Contact
Status Completed
Phase
Start date December 15, 2016
Completion date January 15, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT05935371 - Consequences of Obstetric Anal Sphincter Injuries on Maternal Psychology and Relationship Experience
Completed NCT06449872 - OB-GYN Clinical Validation Study N/A
Completed NCT04181840 - Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection N/A
Active, not recruiting NCT05354284 - Physical and Mental Health Among Sexual and Gender Minorities During Pregnancy, Birth and Postpartum
Active, not recruiting NCT04483986 - Does Rectus Re-approximation Cause Adhesion After Cesarean Section? N/A
Completed NCT04903977 - Detection of Obstetric Anal Sphincter Injuries With ONIRY Device N/A
Terminated NCT03478163 - Antibiotics During Intrauterine Balloon Tamponade Placement Phase 4
Not yet recruiting NCT06325319 - Effect of Community Engagement Using M-Mama Champions N/A
Recruiting NCT04664660 - Endometriosis and Obstetric Outcomes
Completed NCT03856307 - Reliability of Simple Sonographic Findings Acquired With Hand-held Apparatuses to Inform Obstetric Diagnosis
Recruiting NCT06273007 - Improving Intrapartum Care for Saving Life at Birth in Ethiopia Through PartoMa Approach N/A
Completed NCT03828630 - Lung Ultrasound to Detect Pulmonary Complications in Critically Ill Parturients
Completed NCT03161184 - Impact of a Smartphone Intervention on Tanzanian Women's Childbirth Location N/A
Completed NCT03653884 - Intra-abdominal Umbilical Vein Aneurysm
Completed NCT03522909 - The Center for Peripartum Optimization
Completed NCT05704179 - Evaluation of the Relationship Between Obstetric Comorbidity Index and Obstetric Quality of Recovery Score
Completed NCT05079139 - Musset's Surgical Technique: Evaluation of Long-term Results (LONGOMUSSET) N/A
Not yet recruiting NCT05307393 - Maternal Positioning to Correct Fetal Occiput Posterior N/A
Completed NCT04536753 - The Utility of Customised Growth Charts for Identifying Macrosomia and the Effect of Intervention
Completed NCT04852237 - Is the Lack of Prior Exposure to Sperm Antigens Associated With Worse Neonatal and Maternal Outcomes?