CompletedNCT03320213Updated Oct 25, 2017

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

An observational study in Threatened Miscarriage in First Trimester, sponsored by Ain Shams University. Completed. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-25.

Sponsored by Ain Shams University · Observational

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 192
Ages: 20 Years to 40 Years
Sex: Female

Study summary

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

Conditions studied

Threatened Miscarriage in First Trimester

Browse trials for

Abortion, Threatened 21

Keywords

CA125
Yolk sac morphology
Threatened miscarriage

In context

Abortion, Threatened

21 studies on the registry are indexed under Abortion, Threatened; 1 is open to participants now.

This study's enrollment of 192 is above the median of 135 across 10 observational studies indexed under Abortion, Threatened.

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Lead sponsor

Ain Shams University is the lead sponsor of 1,953 studies on the registry; 430 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 40 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes
Sampling method: Probability sample

Study population

Pregnant women at age of 20- 40 years Pregnancy at 6-10 weeks women with single intrauterine spontaneous pregnancy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 192 participants (actual)
Patient registry: No

What researchers measure

Primary outcomes

Evaluation of serum CA125
Measuring serum level of CA125 by ELIZA kits.
Time frame: 6 - 10 weeks
Evaluation of yolk sac morphology
Evaluating yolk sac size and shape by transvaginal ultrasound
Time frame: 6 - 10 weeks

Secondary outcomes

follow up of participants
measuring fetal heart rate by transvaginal ultrasound.
Time frame: up to 20 weeks
follow up of participants
measuring crown rump length by transvaginal ultrasound.
Time frame: up to 20 weeks.

Study locations

No study locations are listed for this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2016 to primary completion in Jul 2017, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 8, 2017
First posted: Oct 25, 2017
StartActual: Oct 1, 2016
Primary completionActual: Jul 30, 2017
CompletionActual: Jul 30, 2017
Last update: Oct 25, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03320213
Lead sponsor: Ain Shams University
Responsible party: Fatma Ahmed Mahmoud Sami (gynecology and obstetrics resident at ministry of health and population, Ain Shams University) — Principal investigator
First posted: Oct 25, 2017
Start date: Oct 1, 2016
Primary completion: Jul 30, 2017
Completion: Jul 30, 2017
Last update: Oct 25, 2017

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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