Corpus Luteum and Uterine Artery Doppler With Serum P and CA125 in Threatened Abortion (CLCA125)

December 5, 2017 updated by: Nesreen Abdel Fattah Abdullah Shehata

Color Doppler of CL and Uterine Artery With Serum Progesterone and CA125 in Threatened Abortion

The purpose of this study is to determine whether assessing color doppler of corpus luteum and uterine artery is useful in predicting patients who will complete pregnancy. The investigators will add to this the usefulness of serum progesterone and CA125 in prediction.

Study Overview

Status

Completed

Conditions

Detailed Description

The introduction of Doppler ultrasound in obstetrics has allowed evaluating hemodynamic characteristics from the first trimester of pregnancy. For example, Kurjak et al.,in one of the first studies using transvaginal pulsed-wave Doppler ultrasound in early pregnancies, identified the uterine arteries in 100% of the patients. The flow blood of the corpus luteum was identified in 75% patients. The measures obtained by Doppler ultrasonography that may have prognostic value to the evolution of pregnancy include uteroplacental blood flow, also known as trophoblastic flow. Jaffe et al. reported that abnormal Doppler findings were associated with a significantly higher prevalence of complicated pregnancies, among women with abnormal Doppler findings, 43% ended in miscarriage, whereas among women with normal findings only 1.4% of women miscarried.Progesterone plays a crucial role in the maintenance of pregnancy. In the presence of sufficient progesterone levels during pregnancy, lymphocytes synthesize a mediator called progesterone induced blocking factor (PIBF), which is anti-abortive in mice . Besides inducing secretary changes in the endometrium and supporting early pregnancy, it modulates the maternal immune response to prevent fetal rejection and relaxes the uterine smooth muscles .CA-125, well-known as a tumor marker for epithelial ovarian cancer , is a high molecular weight glycoprotein that is produced not only by ovarian cancer, but also by nonovarian tumors, normal epithelia of the peritoneum, the endometrium, the fallopian tube, and the ovary. Because CA-125 is also produced by the endometrium, some authors suggest that CA-125 can be used as a marker for endometrial receptivity in patients undergoing IVF . Its role as a predictor for pregnancy outcome is controversial .

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 018
        • Beni-Suef University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant females >8 weeks but < 20 weeks gestation. They are presenting with a complaint of threatened abortion to our outpatient ANC clinic.

Description

Inclusion Criteria:

  • patients with pregnancy between 8 to 20 weeks of gestation,
  • who were diagnosed with threatened abortion.

Exclusion Criteria:

  • patients with multiple pregnancies,
  • molar pregnancy,
  • ectopic pregnancy,
  • amenorrhea with different etiologies of pregnancy,
  • maternal history of systemic diseases and uterine anatomic abnormalities
  • patients who did not have their outcome data through week 20 of gestation due to relocation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Threatened abortion
Pregnant patients > 8 weeks gestation coming to the ANC clinic with mild vaginal bleeding but healthy viable intrauterine pregnancy. Vaginal color doppler for uterine artery and corpus luteum together with serum progesterone and CA125 will be assessed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viable fetus (According to WHO viable fetus >500 gm or > 20 weeks)
Time Frame: from 20 weeks till 21 weeks gestation
The investigators will assess how many patients in both groups reached viability of fetus. According to WHO viable fetus >500 gm or > 20 weeks.
from 20 weeks till 21 weeks gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resistance index of uterine artery and corpus luteum
Time Frame: from 8 weeks till 20 weeks
Vaginal color doppler of uterine artery and corpus luteum for all pregnant patients in the study at first visit in ANC clinic .
from 8 weeks till 20 weeks
serum CA125 and progesterone
Time Frame: from 8 weeks till 20 weeks gestation
serum CA125 and progesterone will be done for all pregnant patients at first visit in ANC clinic
from 8 weeks till 20 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nesreen Abdel Fattah Abdullah Shehata

Collaborators

Beni-Suef University

Investigators

  • Principal Investigator: Nesreen A Shehata, MD, Beni-Suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

April 5, 2015

First Submitted That Met QC Criteria

April 17, 2015

First Posted (Estimate)

April 20, 2015

Study Record Updates

Last Update Posted (Actual)

December 7, 2017

Last Update Submitted That Met QC Criteria

December 5, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beni-Suef 9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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