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

Primary Purpose

Abortion Threatened

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Abortion Threatened

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

threatened miscarriage

Arm Description

ultrasound ,CA125,progesterone

Outcomes

Primary Outcome Measures

ultra sound
presence of fetal heart rate

Secondary Outcome Measures

Full Information

First Posted
January 6, 2019
Last Updated
February 2, 2019
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03797508
Brief Title
Biochemical Versus Ultrasound Findings as Predictors of Fetal Loss in Cases of First Trimester Threatened Miscarriage
Official Title
Biochemical Versus Ultrasound Findings as Predictors of Fetal Loss in Cases of First Trimester Threatened Miscarriage
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: the fetal heart rate, the crown rump length gestational sac diameter 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion Threatened

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
threatened miscarriage
Arm Type
Other
Arm Description
ultrasound ,CA125,progesterone
Intervention Type
Diagnostic Test
Intervention Name(s)
ultrasound
Other Intervention Name(s)
progesterone, CA125
Intervention Description
To evaluate the accuracy of ultrasound findings in comparison to serum CA125and progesterone in predicting fetal demise in cases of first trimester threatened miscarriage.
Primary Outcome Measure Information:
Title
ultra sound
Description
presence of fetal heart rate
Time Frame
the 12th week of gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed k abdelwahab, master
Phone
01000849822
Ext
002
Email
m.k.ali1987@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
amany a mahmoud
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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