Ultrasound Predictors of Early Pregnancy Failure in Patients With Recurrent Pregnancy Loss
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03178682|
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : March 6, 2018
|Condition or disease||Intervention/treatment|
|Recurrent Pregnancy Loss Early Pregnancy Failure||Diagnostic Test: ultrasound parameters|
- 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.
- 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.
- 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.
- 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.
- 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.
- 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|
|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|
- 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.
- 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
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
|Ain shams university|
|Cairo, Egypt, +202|
|Study Director:||Hassan A Bayomy, MD||Professor|
|Study Director:||Amgad E Abou Gamrah, MD||Professor|