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

NCT06797557 | Recruiting DMC

• 1 other identifier: N 363
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Threatened Miscarriage

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

  continuation of pregnancy beyond 12 weeks of gestation

  12 weeks of gestational age

Interventions

2D Ultrasound DIAGNOSTIC_TEST

* 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

3D ultrasound DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 19 Years - 39 Years
• Gender Eligibility Details: Pregnant women with threatened abortion
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

One hundred and twenty women with threatened abortion.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

2 ml venous blood samples were collected for hormonal measurement from the brachial vein of the patients in plain tubes. All blood samples were centrifuged for 10 minutes at 1,000 RPM at room temperature and the serum extracted and frozen at -20oC. * Serum HCG concentrations (intact HCG plus the HCG β-subunit) were quantified using an automated immunoassay technique and expressed in IU/L using the World Health Organization Third International Reference. * Progesterone assay principle combines an enzyme immunoassay competition method with final fluorescent detection. Levels were quantified using an automated immunoassay and expressed in ng/mL

MeSH Terms

Conditions

Abortion, Threatened

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ahmed Maged

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged

CONTACT

+201005227404; ahmedmaged@cu.edu.eg

Ahmed chamel

CONTACT

+20 110 066 2255; ahmed-chamel@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 28, 2025
• Study Start: February 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 4, 2025

Record last verified: 2025-02

Locations

EG (1)