Clinical trial NCT03178682: Ultrasound Predictors of Early Pregnancy Failure in Patients With Recurrent Pregnancy Loss
Official title: Ultrasound Predictors of Early Pregnancy Failure in Patients With Recurrent Pregnancy Loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Pregnancy Loss
Early Pregnancy Failure
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 90 pregnant females with history of recurrent pregnancy loss

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

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.

Eligibility 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

Primary outcomes:
measure: number of patients develops 1st trimester pregnancy loss
timeFrame: within the first 13 weeks of pregnancy.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
affiliation: Professor
name: Hassan A Bayomy, MD
role: STUDY_DIRECTOR
affiliation: Professor
name: Amgad E Abou Gamrah, MD
role: STUDY_DIRECTOR
References: