Clinical trial NCT06797557: Biochemical, 2D and 3D Ultrasonographic Predictors of Pregnancy Outcome in Women With Threatened Abortion
Official title: Biochemical, 2D and 3D Ultrasonographic Predictors of Pregnancy Outcome in Women With Threatened Abortion: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Threatened Miscarriage
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 120
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred and twenty women with threatened abortion.

Brief 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

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 12 weeks of gestational age
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Cairo University
name: Ahmed Maged
role: PRINCIPAL_INVESTIGATOR
References: