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

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.

Study Overview

• Status: Completed
• Conditions: First Trimester Abortion
• Intervention / Treatment: Diagnostic test: ultrasound

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 Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• Egypt
  • Old Cairo
    • Cairo, Old Cairo, Egypt, 11562
      • kasr Al Aini, Faculty of Medicine, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

126 pregnant women between 6- 13 weeks

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Actual): June 26, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound measurments
• Other Study ID Numbers: MS-521-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No