Placental Vasculature for Prediction of Recurrent Fetal Growth Restriction

Obstetric Complication Clinical Trial

Official title:

3DPD of the Placenta in Fetal Growth Restriction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04399174
• Other study ID #: khalid8
• Status: Completed
• Start date: December 15, 2016
• Est. completion date: January 15, 2020

Study information

• Verified date: May 2020
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 15, 2020
• Est. primary completion date: May 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Obstetric Complication

Intervention

Device:
• US

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

References & Publications (1)

Lédée-Bataille N, Laprée-Delage G, Taupin JL, Dubanchet S, Frydman R, Chaouat G. Concentration of leukaemia inhibitory factor (LIF) in uterine flushing fluid is highly predictive of embryo implantation. Hum Reprod. 2002 Jan;17(1):213-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	placental volume	Assessment of placental volume.	11-13 week
Primary	vascularization index (VI)	expressed as percentage, measures the number of colour voxels in the studied volume, representing the blood vessels within the tissue	11-13 week
Primary	uterine doppler	uterine artery pulsatility index	11-13 week
Primary	flow index (FI)	the average colour value of all colour voxels, representing average colour intensity.	11-13 week
Primary	vascularization flow index (VFI)	the average colour value of all grey and colour voxels, which represents both blood flow and vascularization	11-13 week

External Links

•   email of the principal investigator