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

NCT03797508 | Unknown

• 1 other identifier: us laboratory miscarriage
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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?

Conditions

Abortion Threatened

Outcome Measures

Primary Outcomes (1)

• ultra sound

  presence of fetal heart rate

  the 12th week of gestation

Study Arms (1)

threatened miscarriage

OTHER

ultrasound ,CA125,progesterone

Diagnostic Test: ultrasound

Interventions

ultrasound 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.

Also known as: progesterone, CA125

threatened miscarriage

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Abortion, Threatened

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• amany a mahmoud

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mohamed k abdelwahab, master

CONTACT

01000849822; m.k.ali1987@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Egypt Cairo

Study Record Dates

• First Submitted: January 6, 2019
• First Posted: January 9, 2019
• Study Start: December 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: September 30, 2019
• Last Updated: February 5, 2019

Record last verified: 2019-02

Locations

EG (1)