Recurrent Pregnancy LossNCT03178682
Ultrasound Predictors of Early Pregnancy Failure in Patients With Recurrent Pregnancy Loss
An observational study of Recurrent Pregnancy Loss and Early Pregnancy Failure, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Recurrent Pregnancy Loss, Early Pregnancy Failure
- What is being tested?
- ultrasound parameters
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 1 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: 90 pregnant females with history of recurrent pregnancy loss
Who may be able to join
- 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.
Who cannot join
- Women who are uncertain of her last menstrual period date.
- Women with irregular menstrual cycles.
- Multiple pregnancies
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
- 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.
- Conditions
- Recurrent Pregnancy Loss, Early Pregnancy Failure
- Being tested
- ultrasound parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound parametersDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients develops 1st trimester pregnancy loss
defined as a non-viable intrauterine pregnancy with either empty gestational sac or gestational sac containing embryo or fetus without fetal heart activity
Measured: within the first 13 weeks of pregnancy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Jan 2017
- Primary completion1 Jul 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy LossStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Rasheedy Ali, Ain Shams University
- Investigators
- Hassan A Bayomy, MD, Study director, ProfessorAmgad E Abou Gamrah, MD, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178682
- Sponsor's protocol ID
- AinShamsU hospital
- Status last verified
- Mar 2018
- First submitted
- 28 May 2017
- Last updated
- 6 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Predictors of Early Pregnancy Failure in Patients With Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT03178682
- Acronym / sponsor ID
- AinShamsU hospital
- Conditions
- Recurrent Pregnancy Loss, Early Pregnancy Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 90 pregnant females with history of recurrent pregnancy loss
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Women who are uncertain of her last menstrual period date.
- Women with irregular menstrual cycles.
- Multiple pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound parametersultrasonographic 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. | Diagnostic test | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan A Bayomy, MD study director
Professor
Amgad E Abou Gamrah, MD study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Pregnancy Loss and Early Pregnancy Failure, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients develops 1st trimester pregnancy loss (time frame: within the first 13 weeks of pregnancy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018.