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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04399174
Other study ID # khalid8
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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