Value of CA125 and Yolk Sac Morphology in Prediction of Pregnancy Outcome in Threatened Miscarriage

Threatened Miscarriage in First Trimester Clinical Trial

Official title:

Value of CA125 and Yolk Sac Morphology in Prediction of Pregnancy Outcome in Threatened Miscarriage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320213
• Other study ID #: 136
• Status: Completed
• Phase: N/A
• First received: October 8, 2017
• Last updated: October 20, 2017
• Start date: October 1, 2016
• Est. completion date: July 30, 2017

Study information

• Verified date: October 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

evaluation of serum CA125 level and yolk sac morphology in women with threatened miscarriage is very important to predict pregnancy outcome

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: July 30, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• pregnant women between 20-40 years. Pregnancy between 6-10 weeks. single intrauterine spontaneous pregnancy. vaginal bleeding or bloody vaginal discharge with or without pelvic pain for patients with threatened miscarriage.

Exclusion Criteria:

• medical disorders with pregnancy. History of recurrent miscarriage. Any maternal disease that would cause an increase in CA125 level. Local gynecological disorders e.g. fibroid. Presence of any uterine malformation. History of congenital abnormalities in previous pregnancy Presence of multiple pregnancy. Presence of anembryonic sac. Absent fetal heart pulsation.

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Abortion, Threatened
• Threatened Miscarriage in First Trimester

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of serum CA125	Measuring serum level of CA125 by ELIZA kits.	6 - 10 weeks
Primary	Evaluation of yolk sac morphology	Evaluating yolk sac size and shape by transvaginal ultrasound	6 - 10 weeks
Secondary	follow up of participants	measuring fetal heart rate by transvaginal ultrasound.	up to 20 weeks
Secondary	follow up of participants	measuring crown rump length by transvaginal ultrasound.	up to 20 weeks.