Biochemical Versus Ultrasound Findings as Predictors of Fetal Loss in Cases of First Trimester Th… (NCT03797508) | Clinical Trial Compass
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Biochemical Versus Ultrasound Findings as Predictors of Fetal Loss in Cases of First Trimester Threatened Miscarriage
Egypt42 participantsStarted 2018-12-01
Plain-language summary
Threatened miscarriage occurs in about one-fifth of pregnancies with an estimated miscarriage rate of 3-16% after successful demonstration of fetal cardiac activity. Various biochemical markers have been studied previously to predict the outcome of threatened miscarriage; However, the results have been conflicting. Several studies have documented that a slow embryonic heart rate at 6.0-7.0 Weeks' gestation is associated with a high rate of first trimester fetal demise.
our aim: To evaluate the accuracy of ultrasound findings in comparison to serum CA125 and progesterone in predicting fetal demise in cases of first trimester threatened miscarriage.
Will this pregnancy be continued after the first trimester or not?
Who can participate
Age range
20 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Singleton Pregnancy.
* Age20-35years.
* Gestational age between6 to 8weeks.
* Threatened miscarriage is diagnosed by vaginal bleeding, closed cervix and positive fetal life.
* Patients who are sure of their dates (three regular menstrual cycles before conception without the use of hormonal contraception.
Exclusion Criteria:
Patients with recurrent miscarriage or pregnancy of unknown location (PUL).
* Patients had ovulation induction medications or on progesterone treatment.
* Patients with past medical history of diabetes mellitus or chronic hypertension.
* Patients who are unsure of the last menstrual period date or with irregular menstrual cycle.
* Pregnancy associated with presence of ovarian cyst.
* Molar pregnancy.
* Those who had a history of maternal disease which would cause an increase in CA-125level. These diseases include chronic pelvic infection, endometriosis, myoma uteri, endometrioma and lung, kidney and hepatic diseases.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.