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CompletedNCT06797557Updated Jul 7, 2026

Biochemical, 2D and 3D Ultrasonographic Predictors of Pregnancy Outcome in Women With Threatened Abortion

An observational study in Threatened Miscarriage, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 19 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
19 Years to 39 Years
Sex
Female
01

Study summary

Three or two measurements (according to GA) using 2D and 3D ultrasound examinations will be done at initial assessment of the participants then after 1 to 2 weeks and at the end of the 12th week of gestation

Read the detailed description

First ultrasound scans: between 6 and 11 weeks of gestation that included the following:

  • Crow- rump length (CRL) measurement using 2D ultrasound. Proper measurement of the CRL was done according to obtaining a true, unflexed, longitudinal section of the embryo or fetus, with the end-points of the crown (the top of the head) and rump (the end of the trunk) clearly defined, and then placing the calipers correctly on these defined end-points.
  • Yolk sac diameter (largest outer to outer measure).
  • Mean gestational sac diameter (arithmetic mean of 3 diameters).
  • Embryonic heart rate. the heart rate was determined from M-mode tracings using electronic calipers .The sweep speed was set at 4 s and the calculation of the heart rate was made by measuring the time interval of two cardiac cycles, using clearly identified points in the M-mode tracing
  • For volume calculation, 3D ultrasound rotational VOCAL method was used. YSV measurement (axial, sagittal and coronal). The sagittal plane was chosen as the reference plane and 'scanned' to obtain the longest axis of the yolk sac. Then a magnification of image was used and the yolk sac moved to the center of the plane. The VOCAL switch was then activated using a 30° rotation angle and the manual setting. Calipers were positioned on the superior and inferior extremities of the structure and after obtaining six sequential planes, the equipment automatically displayed the yolk sac as a 3D image with its volume in cm3.

Follow up scans was done one to two weeks later according the patient condition then at the end of 1st trimester where the previously mentioned parameters were measured.

02

Conditions studied

  • Threatened Miscarriage

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03

In context

Abortion, Threatened

22 studies on the registry are indexed under Abortion, Threatened; 2 are open to participants now.

This study's enrollment of 120 is below the median of 150 across 11 observational studies indexed under Abortion, Threatened.

Browse Abortion, Threatened studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

One hundred and twenty women with threatened abortion.

Inclusion criteria

  • Age 19 -39 years
  • BMI 18-25 kg/m2
  • Singleton pregnancy between 6 to 11 gestational weeks of pregnancy.
  • First trimester threatened abortion is usually diagnosed in women with history of vaginal bleeding or spotting and/or abdominal pain in whom a live embryo can visualized on scan
  • Gestational age (GA) calculated by the last menstrual period date (LMP) in women with sure dates and regular menstrual cycles and confirmed by transvaginal sonography performed up to the 11th gestational week, using the crown-rump length

Exclusion criteria

Exclusion Criteria:

  • Uterine malformations or pathology as submucous myoma
  • Cervical abnormalities as polypi or severe chronic cervicitis
  • Chronic medical conditions as uncontrolled diabetes or hypertension
  • Smoking or drug abuse during this pregnancy
  • Pregnancies resulting from infertility treatments and assisted reproductive techniques.
  • Women with exogenous progesterone support
  • Use of abortion induction drugs\
  • First trimester vaginal bleeding or spotting and/or abdominal pain and diagnosed by ultrasound as missed (absence of cardiac activity within fetal pole), incomplete (endometrial thickness between 5 to 15 mm), complete (thin and regular endometrium), anembryonic (gestational sac without a detectable fetal pole) and ectopic (+ve pregnancy test with empty gestational sac
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Diagnostic test2D Ultrasound

    * Crow- rump length (CRL) measurement using 2D ultrasound. Proper measurement of the CRL was done according to obtaining a true, unflexed, longitudinal section of the embryo or fetus, with the end-points of the crown (the top of the head) and rump (the end of the trunk) clearly defined, and then placing the calipers correctly on these defined end-points. * Yolk sac diameter (largest outer to outer measure). * Mean gestational sac diameter (arithmetic mean of 3 diameters). * Embryonic heart rate. the heart rate was determined from M-mode tracings using electronic calipers .The sweep speed was set at 4 s and the calculation of the heart rate was made by measuring the time interval of two cardiac cycles, using clearly identified points in the M-mode tracing

  • Diagnostic test3D ultrasound

    3D ultrasound rotational VOCAL method was used. YSV measurement (axial, sagittal and coronal). The sagittal plane was chosen as the reference plane and 'scanned' to obtain the longest axis of the yolk sac. Then a magnification of image was used and the yolk sac moved to the center of the plane. The VOCAL switch was then activated using a 30° rotation angle and the manual setting. Calipers were positioned on the superior and inferior extremities of the structure and after obtaining six sequential planes, the equipment automatically displayed the yolk sac as a 3D image with its volume in cm3

06

What researchers measure

Primary outcomes

  1. Ongoing pregnancy rate

    continuation of pregnancy beyond 12 weeks of gestation

    Time frame: 12 weeks of gestational age

07

Study locations

1 site
  • Kasr Alainy medical school
    Cairo, 12111, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06797557
Lead sponsor
Cairo University
Responsible party
Ahmed M Maged, MD (professor, Cairo University) — Principal investigator
First posted
Jan 28, 2025
Start date
Feb 1, 2025
Primary completion
May 12, 2026
Completion
Jun 25, 2026
Last update
Jul 7, 2026

Study contacts

Ahmed Maged
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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