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Ultrasound Predictors of Early Pregnancy Failure in Patients With Recurrent Pregnancy Loss

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ClinicalTrials.gov Identifier: NCT03178682
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Radwa Rasheedy Ali, Ain Shams University

Brief Summary:
evaluation of the role of ultrasonographic parameters (mean gestational sac diameter, yolk sac diameter, crown rump length, embryonic heart rate and uterine artery Doppler) in predicting early pregnancy failure in patients with recurrent pregnancy loss

Condition or disease Intervention/treatment
Recurrent Pregnancy Loss Early Pregnancy Failure Diagnostic Test: ultrasound parameters

Detailed Description:
  1. Mean gestational sac diameter (MSD) is determined by measuring the mean of 3 diameters (longitudinal, antero-posterior and transverse) which are measured from inside of the sac excluding the decidual reaction from the measurement. It is normally eccentric in location embedded in endometrium, and has a smooth; round or oval shape.
  2. Yolk sac is measured by placing calipers on the inner limits of the longer diameter. It usually appears at the periphery of the gestational sac and should not be floating within the sac. Size of the sac, shape, echogenicity of the rim and center of sac, its number and degenerative changes such as calcification will be evaluated. YS having diameter between 3-7mm, rounded shape, absence of degenerative changes, presence of echogenic rim and hypoechoic center are considered normal. Any deviation from above parameters is considered abnormal.
  3. Crown-rump length (CRL) is the length of the embryo from the top of its head to bottom of torso excluding the yolk sac and the extremities, to be measured in sagittal plane of the embryo and recorded as an average of three measurements.
  4. The MGSD-CRL ratio was calculated as the difference between the MGSD and the CRL if less than 5 mm are prone to first trimester miscarriage.
  5. Embryonic heart rate by M-mode calculated as beat per minute using software of ultrasound machine after measuring by electronic calibers of distance between 2 heart waves on frozen M-mode image.
  6. Uterine artery Doppler with measurement of systolic/diastolic (S/D) ratio, resistance index (RI) and pulsatility index (PI) of uterine arteries.

Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasound Predictors of Early Pregnancy Failure in Patients With Recurrent Pregnancy Loss
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • Diagnostic Test: ultrasound parameters
    ultrasonographic parameters (mean gestational sac diameter, yolk sac diameter, crown rump length, embryonic heart rate and uterine artery Doppler) in predicting early pregnancy failure in patients with recurrent pregnancy loss.


Primary Outcome Measures :
  1. number of patients develops 1st trimester pregnancy loss [ Time Frame: within the first 13 weeks of pregnancy. ]
    defined as a non-viable intrauterine pregnancy with either empty gestational sac or gestational sac containing embryo or fetus without fetal heart activity



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
90 pregnant females with history of recurrent pregnancy loss
Criteria

Inclusion Criteria:

  • A positive pregnancy test result.
  • Single intrauterine pregnancy.
  • Gestational age by last menstrual period of 6-10 weeks in patients with regular cycles and sure of her last menstrual period date.
  • History of recurrent pregnancy loss which is defined as three or more consecutive pregnancy losses.

Exclusion Criteria:

  • Women who are uncertain of her last menstrual period date.
  • Women with irregular menstrual cycles.
  • Multiple pregnancies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178682


Locations
Egypt
Ain shams university
Cairo, Egypt, +202
Sponsors and Collaborators
Ain Shams University
Investigators
Study Director: Hassan A Bayomy, MD Professor
Study Director: Amgad E Abou Gamrah, MD Professor

Responsible Party: Radwa Rasheedy Ali, lecturer of obstetrics and gynecology, Ain Shams University
ClinicalTrials.gov Identifier: NCT03178682     History of Changes
Other Study ID Numbers: AinShamsU hospital
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Abortion, Spontaneous
Fetal Death
Abortion, Habitual
Pregnancy Complications
Death
Pathologic Processes