Preterm LaborNCT04532086
Uterocervical Angle and Preterm Labour
An observational study of Preterm Labor, run by Ain Shams Maternity Hospital.
Trial summary
To determine whether a novel ultrasonographic marker, uterocervical angle, correlates with risk of spontaneous preterm birth Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preterm Labor
- What is being tested?
- Uterocervical angle
- How many people
- 197 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2020to Sep 2021
- 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 18 to 40 years
- Women only
- Adult
Study population: 197 pregnant women with singleton gestations between (18 - 28) weeks with history of previous preterm deliveries or mid-trimesteric abortions.
Who may be able to join
- Maternal age (18_40).
- BMI (20_34).
- singleton gestations between (18 - 28) weeks.
- Multiparity.
- History of previous preterm deliveries or mid-trimesteric abortions.
Who cannot join
- Loss of follow up.
- Preterm premature rupture of membranes(PPROM).
- Placental abnormalities.
- Past history of cervical operations.
- Multifetal pregnancy.
- Polyhydramnios.
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- Steroids intake .
- Medically or obstetric indicated pregnancy termination.
- Serious maternal or fetal problems.
- Cerclage during current pregnancy before the screening.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Relationship Between Uterocervical Angle and Prediction of Spontaneous Preterm Birth
To determine whether a novel ultrasonographic marker, uterocervical angle, correlates with risk of spontaneous preterm birth
Read the detailed description
The uterocervical angle is the triangular segment measured between the lower uterine segment and the cervical canal, yielding a measurable angle. The first ray was placed from the internal os to the external os. The calipers were placed where the anterior and posterior walls of the cervix touch the internal and external os along the endocervical canal. If the cervix was curved, the first ray was also drawn from the internal os to the external os as a straight line. A second ray was then drawn to delineate the lower uterine segment. This ray was traced up the anterior uterine segment to a distance allowed by the preloaded image. Ideally, the second ray would reach 3cm up the lower uterine segment in order to establish an adequate measurement. The anterior angle in between the two rays was measured with a protractor. In the presence of funneling, the first ray was placed to measure the length of remaining cervix. The second caliper was placed from the innermost portion of measurable cervix and extended to the lower uterine segment. In the event that the lower uterine segment was found to be irregular, the second caliper was placed centrally along the segment. In the event of a retroverted uterus, the angle should be measured in a similar fashion with the first ray along the measurable cervix and the second ray traced along the lower uterine segment. Unlike in an anteverted or axial positioned uterus, however, the posterior side of the angle closer to the intrauterine contents should then be measured.
- Conditions
- Preterm Labor
- Being tested
- Uterocervical angle
- Keywords
- uterocervical angle, Preterm birth
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterocervical angleDiagnostic test
Transvaginal ultrasound examination will be performed at 18-28 weeks gestation in (197) pregnant women with live singleton fetuses, attending routine prenatal care services. Measuring length of uterine cervix at (18-28) weeks \& evaluation of dilatation of internal os \& measurement of uterocervical angle between(18-28)weeks gestational age.
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age at birth
Preterm labour is defined as regular contractions of the uterus resulting in changes in the cervix that start before 37 weeks of pregnancy. Changes in the cervix include effacement (the cervix thins out) and dilation (the cervix opens so that the fetus can enter the birth canal).
Measured: 6 months
Secondary outcomes (1)
Apgar score at 1 and 5 minutes
Appearance (skin color) Pulse (heart rate) Grimace response (reflexes) Activity (muscle tone) Respiration (breathing rate and effort)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start20 Nov 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- 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
- 197 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Shaaban Abd Al Razik Ibrahim, Ain Shams Maternity Hospital
- Investigators
- Osama Is Kamel, lecturer, Study director, LecturerWessam Mg Abuelghar, Professor, Study director, ProfessorAhmed Kh Makled, Professor, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532086
- Sponsor's protocol ID
- UCA in preterm birth
- Status last verified
- Nov 2020
- First submitted
- 26 Aug 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Daskalakis G, Theodora M, Antsaklis P, Sindos M, Grigoriadis T, Antsaklis A, Papantoniou N, Loutradis D, Pergialiotis V. Assessment of Uterocervical Angle Width as a Predictive Factor of Preterm Birth: A Systematic Review of the Literature. Biomed Res Int. 2018 Dec 26;2018:1837478. doi: 10.1155/2018/1837478. eCollection 2018.
PubMed 30687736Swanson K, Grobman WA, Miller ES. Is Uterocervical Angle Associated with Gestational Latency after Physical Exam Indicated Cerclage? Am J Perinatol. 2018 Jul;35(9):840-843. doi: 10.1055/s-0037-1621734. Epub 2018 Jan 24.
PubMed 29365330van der Merwe J, Couck I, Russo F, Burgos-Artizzu XP, Deprest J, Palacio M, Lewi L. The Predictive Value of the Cervical Consistency Index to Predict Spontaneous Preterm Birth in Asymptomatic Twin Pregnancies at the Second-Trimester Ultrasound Scan: A Prospective Cohort Study. J Clin Med. 2020 Jun 8;9(6):1784. doi: 10.3390/jcm9061784.
PubMed 32521741Oskovi Kaplan ZA, Ozgu-Erdinc AS. Prediction of Preterm Birth: Maternal Characteristics, Ultrasound Markers, and Biomarkers: An Updated Overview. J Pregnancy. 2018 Oct 10;2018:8367571. doi: 10.1155/2018/8367571. eCollection 2018.
PubMed 30405914
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Uterocervical Angle and Prediction of Spontaneous Preterm Birth
- ClinicalTrials.gov ID
- NCT04532086
- Acronym / sponsor ID
- UCA in preterm birth
- Conditions
- Preterm Labor
- Keywords
- uterocervical angle, Preterm birth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 197 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 20 Nov 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 31 Aug 2020 (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.
To determine whether a novel ultrasonographic marker, uterocervical angle, correlates with risk of spontaneous preterm birth
Detailed description
The uterocervical angle is the triangular segment measured between the lower uterine segment and the cervical canal, yielding a measurable angle. The first ray was placed from the internal os to the external os. The calipers were placed where the anterior and posterior walls of the cervix touch the internal and external os along the endocervical canal. If the cervix was curved, the first ray was also drawn from the internal os to the external os as a straight line. A second ray was then drawn to delineate the lower uterine segment. This ray was traced up the anterior uterine segment to a distance allowed by the preloaded image. Ideally, the second ray would reach 3cm up the lower uterine segment in order to establish an adequate measurement. The anterior angle in between the two rays was measured with a protractor. In the presence of funneling, the first ray was placed to measure the length of remaining cervix. The second caliper was placed from the innermost portion of measurable cervix and extended to the lower uterine segment. In the event that the lower uterine segment was found to be irregular, the second caliper was placed centrally along the segment. In the event of a retroverted uterus, the angle should be measured in a similar fashion with the first ray along the measurable cervix and the second ray traced along the lower uterine segment. Unlike in an anteverted or axial positioned uterus, however, the posterior side of the angle closer to the intrauterine contents should then be measured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 197 pregnant women with singleton gestations between (18 - 28) weeks with history of previous preterm deliveries or mid-trimesteric abortions.
Key inclusion criteria (5 listed)
- Maternal age (18_40).
- BMI (20_34).
- singleton gestations between (18 - 28) weeks.
- Multiparity.
- History of previous preterm deliveries or mid-trimesteric abortions.
Key exclusion criteria (10 listed)
- Loss of follow up.
- Preterm premature rupture of membranes(PPROM).
- Placental abnormalities.
- Past history of cervical operations.
- Multifetal pregnancy.
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 |
|---|---|---|
| Uterocervical angleTransvaginal ultrasound examination will be performed at 18-28 weeks gestation in (197) pregnant women with live singleton fetuses, attending routine prenatal care services. Measuring length of uterine cervix at (18-28) weeks \& evaluation of dilatation of internal os \& measurement of uterocervical angle between(18-28)weeks gestational age. | Diagnostic test | – |
Primary outcome
Gestational age at birth
Time frame: 6 months
Preterm labour is defined as regular contractions of the uterus resulting in changes in the cervix that start before 37 weeks of pregnancy. Changes in the cervix include effacement (the cervix thins out) and dilation (the cervix opens so that the fetus can enter the birth canal).
1 secondary outcome
Apgar score at 1 and 5 minutes
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Background: PubMed 30687736Daskalakis G, Theodora M, Antsaklis P, Sindos M, Grigoriadis T, Antsaklis A, Papantoniou N, Loutradis D, Pergialiotis V. Assessment of Uterocervical Angle Width as a Predictive Factor of Preterm Birth: A Systematic Review of the Literature. Biomed Res Int. 2018 Dec 26;2018:1837478. doi: 10.1155/2018/1837478. eCollection 2018.
- Background: PubMed 29365330Swanson K, Grobman WA, Miller ES. Is Uterocervical Angle Associated with Gestational Latency after Physical Exam Indicated Cerclage? Am J Perinatol. 2018 Jul;35(9):840-843. doi: 10.1055/s-0037-1621734. Epub 2018 Jan 24.
- Background: PubMed 32521741van der Merwe J, Couck I, Russo F, Burgos-Artizzu XP, Deprest J, Palacio M, Lewi L. The Predictive Value of the Cervical Consistency Index to Predict Spontaneous Preterm Birth in Asymptomatic Twin Pregnancies at the Second-Trimester Ultrasound Scan: A Prospective Cohort Study. J Clin Med. 2020 Jun 8;9(6):1784. doi: 10.3390/jcm9061784.
- Background: PubMed 30405914Oskovi Kaplan ZA, Ozgu-Erdinc AS. Prediction of Preterm Birth: Maternal Characteristics, Ultrasound Markers, and Biomarkers: An Updated Overview. J Pregnancy. 2018 Oct 10;2018:8367571. doi: 10.1155/2018/8367571. eCollection 2018.
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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.
Osama Is Kamel, lecturer study director
Lecturer
Wessam Mg Abuelghar, Professor study director
Professor
Ahmed Kh Makled, Professor study director
Professor
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labor, run by Ain Shams Maternity Hospital.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Sh Abd Al Razik (+2001098988160, drmuscle90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational age at birth (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04532086, which also lists 4 linked publications.
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 16 Nov 2020.