Early Pregnancy Ultrasound Parameters Including Corpus Luteum Doppler in Prediction of First Trimester Pregnancy Outcome in Spontaneous Pregnancies.

Completed

• Conditions: Fetal Conditions

• Registration Number: NCT07204028
• Lead Sponsor: Cairo University

Brief Summary

The synthesis of progesterone by corpus luteum is extremely important for the maintenance of normal pregnancy in the first seven weeks. Similarly, the production of progesterone by the placental syncytiotrophoblast increases progressively during the first weeks of gestation, so that in eight and a half weeks the placenta and corpus luteum contribute in equal amounts of progesterone. However, from the eighth week, the placental contribution is sufficient to maintain gestation. Angiogenesis in the corpus luteum occurs under physiologic circumstances in each menstrual cycle and functionally is very important for maintenance of early pregnancy. This role implies a potential correlation between abnormal function of corpus luteum and possible abnormal pregnancy including abortion. Using color Doppler sonography, it was feasible to distinguish the ovary containing an active corpus luteum from the inactive ovary. The technique is simple to use, and the results are displayed obviously (Abd-elfatah \& Megahed, 2020). 6 and

Detailed Description

Gestational sac (GS), yolk sac (YS), crown-rump length (CRL), and heart rate (HR) and corpus luteum Doppler are the parameters measured to evaluate early pregnancy. Deviations in the ultrasound parameters have been alternatively investigated to predict first trimester pregnancy loss. The amniotic sac, which becomes visible at the beginning of the 7th week of gestation, is normally not contemplated in the prediction models, however it assists in dating a pregnancy correctly (Detti et al., 2020).

The aim of this study is to evaluate gestational sac diameter (GSD), yolk sac diameter (YSD), heart rate (HR), CRL and corpus luteum Doppler at 6-12 gestational weeks (GW) as predictors of first trimester outcome.

Study Timeline

• Study Start: 2025-01-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-21
• Status Verified: 2025-09
• Study First Submitted: 2025-09-24
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• The age of women in the studied population was up to 40 years.
• Live singleton pregnancy with gestational age 6-9 gestational weeks.
• Patients with threatened miscarriage were included.

Exclusion Criteria

• Ectopic pregnancy.
• Multiple pregnancies.
• Vesicular mole.
• Miscarriage in first visit.
• Fetal anomaly.
• Known uterine anomalies.
• Significant pre-pregnancy maternal diseases (e.g., hypertension - diabetes mellitus-systemic lupus) or known thrombophilia (e.g., antiphospholipid syndrome).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
New predictors of first trimester pregnancy outcome	6 months	Evaluation of corpus luteum Doppler as predictor of first trimester outcome.

Trial Locations

Locations (1)

Faculty of Medicine, Cairo University; 🇪🇬 Giza, Cairo Governorate, Egypt

Faculty of Medicine, Cairo University

🇪🇬Giza, Cairo Governorate, Egypt