Early Pregnancy Ultrasound Measurements and Prediction of First Trimester Pregnancy Loss.

Completed

• Conditions: First Trimester Abortion

• Registration Number: NCT06540092
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

Ultrasound measurements of fetus during first trimester may be an indicator of first trimester pregnancy loss. Investigators took 4 measurements of the fetus on 2 intervals during first trimester to confirm this hypothesis.

Detailed Description

Ultrasound examination of gestational sac (GS) diameter, yolk sac (YS) diameter, crown rump length (CRL) diameter, embryonal heart rate (HR) using Samsung Medison SonoAce R3 through transvaginal probes (6.5 MHz) was conducted on 126 pregnant women. At least 2 scans were done for each participant one between 6-8 weeks and another one by the end of first trimester. Results then were compared to get the cut off values that can predict pregnancy loss.

Study Timeline

• Study Start: 2024-03-19
• Primary Completion: 2024-06-26
• Study Completion: 2024-07-30
• Status Verified: 2024-08
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-01
• Last Update Submitted: 2024-08-01
• Study First Posted: 2024-08-06
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

Inclusion Criteria

• • Healthy pregnant female patient in the reproductive age group; 18 - 40 years old.

  • Gestational age: 6 - 13 weeks of gestations.
  • Singlton or multifetal pregnancy.
  • Any mode of conception included spontaneous, after superovulation with clomiphene citrate or letrozole with, or without, intrauterine insemination (IUI), and in vitro fertilization (IVF) after superovulation with gonadotropins.

Exclusion Criteria

• • Patient with unsure date for the last menstrual period.

  • Pregnant women above 13 weeks gestation.
  • Patient with symptoms of threatened abortion or ectopic pregnancy at the initial antenatal visit.
  • Patient unable to come for follow up.
  • Any medical disorders as DM, HTN, ...

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The relation between early pregnancy ultrasound measurements (GSD, YSD, CRL, HR), viability, and continuation of pregnancy till 13 weeks of gestation.	6-7 weeks	2 measures of the fetus were obtained and compared to get first trimester pregnancy outcome

Trial Locations

Locations (1)

kasr Al Aini, Faculty of Medicine, Cairo University; 🇪🇬 Cairo, Old Cairo, Egypt