Biochemical Versus Ultrasound Findings as Predictors of Fetal Loss in Cases of First Trimester Threatened Miscarriage

NCT ID: NCT03797508

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2019-09-30

Brief 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?

Detailed Description

we are comparing between the accuracy of vaginal ultra sound versus serum progesterone level and serum CA 125 level in predicting of fetal demise in cases of threatened miscarriage three vaginal ultrasounds will be done ) the first one will be done at six to eight weeks of pregnancy to the patients who fulfill the criteria in this us we will make sure that the cardiac pulsations are present and measure the following:

1. the fetal heart rate,

2. the crown rump length

3. gestational sac diameter

4. yolk sac diameter. b) The second ultra sound will be after two weeks from the first one to follow up the patient for pregnancy survival, take the same measures again and correlate them with the results of laboratory investigations to select the investigation which is most accurate in anticipating outcome in cases of threatened abortion.

C) the third one will be at the end of first trimester (13 weeks) to ensure fetal viability.

. embryonic bradycardia and absence of yolk sac or smaller yolk sac than expected for any given gestational age are prognostic factors of poor pregnancy outcome in the first 12 weeks of pregnancy women with small for age gestational sac are more prone to have miscarriage we will do laboratory investigation in the form of A) Serum progesterone: low maternal P levels have been useful in predicting spontaneous abortion in threatened pregnancies with a sensitivity of 80% (<10 ng /mL) so, this will be our cutoff value. B) Serum CA 125 :we will take a level of 51.5 as cut off value.this is the upper level of normal we will do them once when the patient presents to us.

Conditions

Abortion Threatened

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

threatened miscarriage

ultrasound ,CA125,progesterone

Group Type: OTHER

ultrasound

Intervention Type: DIAGNOSTIC_TEST

To evaluate the accuracy of ultrasound findings in comparison to serum CA125and progesterone in predicting fetal demise in cases of first trimester threatened miscarriage.

Interventions

ultrasound

To evaluate the accuracy of ultrasound findings in comparison to serum CA125and progesterone in predicting fetal demise in cases of first trimester threatened miscarriage.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

progesterone; CA125

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

amany abdel monem mahmoud

Egypt Cairo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

amany a mahmoud

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

mohamed k abdelwahab, master

Role: CONTACT

m.k.ali1987@gmail.com

01000849822 ext. 002

Other Identifiers

us laboratory miscarriage

Identifier Type: -

Identifier Source: org_study_id