Ultrasound Predictors of Pregnancy Outcome in Women with Threatened Miscarriage
Biochemical, 2D and 3D Ultrasonographic Predictors of Pregnancy Outcome in Women With Threatened Abortion: A Prospective Cohort Study
This study is testing if 2D and 3D ultrasound measurements can help predict the outcomes of pregnancies in women who are at risk of miscarriage.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 19 Years to 39 Years |
| Sex | Female |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06797557 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of 2D and 3D ultrasound measurements in predicting pregnancy outcomes for women experiencing threatened miscarriage. Participants will undergo initial ultrasound scans between 6 and 11 weeks of gestation, followed by additional scans at 1-2 weeks and at the end of the 12th week. Key measurements will include crown-rump length, yolk sac diameter, mean gestational sac diameter, and embryonic heart rate, utilizing advanced imaging techniques for accurate assessments. The study will focus on identifying biochemical and ultrasonographic predictors that may influence pregnancy viability.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 19-39 years with a singleton pregnancy between 6 to 11 weeks of gestation experiencing symptoms of threatened abortion.
Not a fit: Patients with uterine malformations, chronic medical conditions, or those undergoing infertility treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into predicting pregnancy outcomes, potentially reducing anxiety and improving management for women facing threatened miscarriage.
How similar studies have performed: While there have been studies exploring ultrasound predictors in pregnancy, this specific combination of 2D and 3D ultrasound measurements in the context of threatened miscarriage is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cairo
- Kasr Alainy medical school — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Ahmed Maged — Cairo University
- Study coordinator: Ahmed Maged
- Email: ahmedmaged@cu.edu.eg
- Phone: +201005227404
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.