NCT04532086

Brief Summary

To determine whether a novel ultrasonographic marker, uterocervical angle, correlates with risk of spontaneous preterm birth

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

November 20, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

August 26, 2020

Last Update Submit

November 13, 2020

Conditions

Preterm Labor

Keywords

uterocervical anglePreterm birth

Outcome Measures

Primary Outcomes (1)

  • 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).

    6 months

Secondary Outcomes (1)

  • Apgar score at 1 and 5 minutes

    6 months

Interventions

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.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

197 pregnant women with singleton gestations between (18 - 28) weeks with history of previous preterm deliveries or mid-trimesteric abortions.

You may qualify if:

  • Maternal age (18\_40).
  • BMI (20\_34).
  • singleton gestations between (18 - 28) weeks.
  • Multiparity.
  • History of previous preterm deliveries or mid-trimesteric abortions.

You may not qualify if:

  • Loss of follow up.
  • Preterm premature rupture of membranes(PPROM).
  • Placental abnormalities.
  • Past history of cervical operations.
  • Multifetal pregnancy.
  • Polyhydramnios.
  • Steroids intake .
  • Medically or obstetric indicated pregnancy termination.
  • Serious maternal or fetal problems.
  • Cerclage during current pregnancy before the screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 30687736BACKGROUND

  • Swanson 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.

    PMID: 29365330BACKGROUND

  • van 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.

    PMID: 32521741BACKGROUND

  • Oskovi 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.

    PMID: 30405914BACKGROUND

MeSH Terms

Conditions

Obstetric Labor, PrematurePremature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Osama Is Kamel, lecturer

    Lecturer

    STUDY DIRECTOR

  • Wessam Mg Abuelghar, Professor

    Professor

    STUDY DIRECTOR

  • Ahmed Kh Makled, Professor

    Professor

    STUDY DIRECTOR

Central Study Contacts

Mohammed Sh Abd Al Razik

CONTACT

+2001098988160drmuscle90@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 26, 2020

First Posted

August 31, 2020

Study Start

November 20, 2020

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

November 16, 2020

Record last verified: 2020-11