NCT05632003

Brief Summary

Preterm delivery occurs in about 5-18% of pregnancies before 37 weeks' gestation all over the world.It is associated with a high prevalence of neurological deficits, developmental disabilities and is a leading cause of infant and neonatal mortality. Many of the methods used for predicting preterm birth has not been proven efficacy and is not currently recommended for use.The length of the cervix has been one of the most useful methods in predicting the risk of premature delivery. Detection rates may be improved if combined with other parameters such as the uterocervical angle as a new predictor of spontaneous preterm birth. In this study we will compare between using the uterocervical angle and cervical length in the prediction of preterm labour.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

November 20, 2022

Last Update Submit

January 28, 2023

Conditions

Preterm Labor

Outcome Measures

Primary Outcomes (1)

  • Early preterm birth

    birth between 32 0/7 and 33 6/7 weeks of gestation

    from 16 0/7 to 36 6/7 weeks of gestation

Secondary Outcomes (1)

  • Late preterm birth

    from 16 0/7 to 36 6/7 weeks of gestation

Other Outcomes (1)

  • Very early preterm birth

    from 16 0/7 to 36 6/7 weeks of gestation

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women attending the obstetrics outpatient clinic at AinShams university maternity hospital

You may qualify if:

  • Singleton pregnancy
  • History of spontaneous preterm birth
  • Recruitment at 16 to 24 weeks of pregnancy
  • Normal growth pattern evaluated by estimated fetal weight or abdominal circumference

You may not qualify if:

  • Medical disorders which can lead to uteroplacental insufficiency
  • Congenital uterine anomalies, as it may change the uterocervical angle.
  • Congenital fetal malformations detected on midtrimesteric anomaly scan
  • Pregnancy on IVF/ICSI
  • Smoking during pregnancy
  • History of cervical trauma
  • Preterm prelabor rupture of the membranes
  • Polyhydramnios
  • Cervical cerclage
  • Antepartum hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams university maternity hospital

Cairo, Egypt

Location

Related Publications (14)

  • Berghella V, Palacio M, Ness A, Alfirevic Z, Nicolaides KH, Saccone G. Cervical length screening for prevention of preterm birth in singleton pregnancy with threatened preterm labor: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Ultrasound Obstet Gynecol. 2017 Mar;49(3):322-329. doi: 10.1002/uog.17388. Epub 2017 Feb 8.

    PMID: 27997053BACKGROUND

  • DeFranco EA, Lewis DF, Odibo AO. Improving the screening accuracy for preterm labor: is the combination of fetal fibronectin and cervical length in symptomatic patients a useful predictor of preterm birth? A systematic review. Am J Obstet Gynecol. 2013 Mar;208(3):233.e1-6. doi: 10.1016/j.ajog.2012.12.015. Epub 2012 Dec 12.

    PMID: 23246314BACKGROUND

  • Di Renzo GC, Cabero Roura L, Facchinetti F, Helmer H, Hubinont C, Jacobsson B, Jorgensen JS, Lamont RF, Mikhailov A, Papantoniou N, Radzinsky V, Shennan A, Ville Y, Wielgos M, Visser GHA. Preterm Labor and Birth Management: Recommendations from the European Association of Perinatal Medicine. J Matern Fetal Neonatal Med. 2017 Sep;30(17):2011-2030. doi: 10.1080/14767058.2017.1323860. No abstract available.

    PMID: 28482713BACKGROUND

  • Dziadosz M, Bennett TA, Dolin C, West Honart A, Pham A, Lee SS, Pivo S, Roman AS. Uterocervical angle: a novel ultrasound screening tool to predict spontaneous preterm birth. Am J Obstet Gynecol. 2016 Sep;215(3):376.e1-7. doi: 10.1016/j.ajog.2016.03.033. Epub 2016 Mar 24.

    PMID: 27018466BACKGROUND

  • Farras Llobet A, Higueras T, Calero IZ, Regincos Marti L, Maiz N, Goya MM, Carreras E. Prospective evaluation of the uterocervical angle as a predictor of spontaneous preterm birth. Acta Obstet Gynecol Scand. 2020 Nov;99(11):1511-1518. doi: 10.1111/aogs.13879. Epub 2020 Jun 3.

    PMID: 32311754BACKGROUND

  • Halimi Asl AA, Safari S, Parvareshi Hamrah M. Epidemiology and Related Risk Factors of Preterm Labor as an obstetrics emergency. Emerg (Tehran). 2017;5(1):e3. Epub 2017 Jan 8.

    PMID: 28286810BACKGROUND

  • Kagan KO, Sonek J. How to measure cervical length. Ultrasound Obstet Gynecol. 2015 Mar;45(3):358-62. doi: 10.1002/uog.14742. Epub 2015 Jan 29. No abstract available.

    PMID: 25632014BACKGROUND

  • Khamees RE, Khattab BM, Elshahat AM, Taha OT, Aboelroose AA. Uterocervical angle versus cervical length in the prediction of spontaneous preterm birth in singleton pregnancy. Int J Gynaecol Obstet. 2022 Feb;156(2):304-308. doi: 10.1002/ijgo.13629. Epub 2021 Feb 23.

    PMID: 33507541BACKGROUND

  • Pawelec M, Palczynski B, Krzemieniewska J, Karmowski M, Korys J, Latkowski K, Karmowski A. Initiation of preterm labor. Adv Clin Exp Med. 2013 Mar-Apr;22(2):283-8.

    PMID: 23709385BACKGROUND

  • Romero R, Dey SK, Fisher SJ. Preterm labor: one syndrome, many causes. Science. 2014 Aug 15;345(6198):760-5. doi: 10.1126/science.1251816. Epub 2014 Aug 14.

    PMID: 25124429BACKGROUND

  • Rundell K, Panchal B. Preterm Labor: Prevention and Management. Am Fam Physician. 2017 Mar 15;95(6):366-372.

    PMID: 28318214BACKGROUND

  • Sen C. Preterm labor and preterm birth. J Perinat Med. 2017 Nov 27;45(8):911-913. doi: 10.1515/jpm-2017-0298. No abstract available.

    PMID: 29055176BACKGROUND

  • Wax JR, Cartin A, Pinette MG. Biophysical and Biochemical Screening for the Risk of Preterm Labor: An Update. Clin Lab Med. 2016 Jun;36(2):369-83. doi: 10.1016/j.cll.2016.01.019. Epub 2016 Mar 25.

    PMID: 27235918BACKGROUND

  • Elmaraghy AM, Shaaban SMA, Elsokkary MS, Elshazly ISMA. Uterocervical angle versus cervical length in the prediction of spontaneous preterm birth in women with history of spontaneous preterm birth: a prospective observational study. BMC Pregnancy Childbirth. 2023 Sep 13;23(1):658. doi: 10.1186/s12884-023-05977-9.

    PMID: 37704977DERIVED

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Mohammed S Elsokkary, MD

    Ainshams university maternity hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 20, 2022

First Posted

November 30, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)