NCT04862182

Brief Summary

Determine the value of intrapartum scan measurement(s) in predicting the mode of delivery.

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

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

April 23, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

April 23, 2021

Last Update Submit

April 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • The rate of intrapartum Cesarean Section

    number of women that failed to progress to normal vaginal delivery and need for intrapartum Cesarean Section (ICS)

    3 hours

Interventions

Intrapartum trans-perineal ultrasound in predicting the mode of delivery.

Eligibility Criteria

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

Women who present to the labour ward in the first stage of labour and willing to participate in the study.

You may qualify if:

  • Nulliparous women
  • Full Term pregnancy
  • Vertex presentation
  • Singleton pregnancy
  • In labour

You may not qualify if:

  • Multiparous women
  • Preterm labour
  • Non vertex presentation
  • Multi-fetal pregnancy
  • Planned for elective Cesarean Section
  • Underlying medical diseases
  • Those unwilling to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Barak O, Levy R, Flidel O, Zaks S, Gillor M, Hagay Z, Vaisbuch E. The Routine Use of Intrapartum Ultrasound in Clinical Decision-Making during the Second Stage of Labor - Does It Have Any Impact on Delivery Outcomes? Gynecol Obstet Invest. 2018;83(1):9-14. doi: 10.1159/000455847. Epub 2017 Feb 22.

  • Brunelli E, Del Prete B, Casadio P, Pilu G, Youssef A. The dynamic change of the anteroposterior diameter of the levator hiatus under Valsalva maneuver at term and labor outcome. Neurourol Urodyn. 2020 Nov;39(8):2353-2360. doi: 10.1002/nau.24494. Epub 2020 Aug 31.

  • Sherer DM, Abulafia O. Intrapartum assessment of fetal head engagement: comparison between transvaginal digital and transabdominal ultrasound determinations. Ultrasound Obstet Gynecol. 2003 May;21(5):430-6. doi: 10.1002/uog.102.

  • Lipschuetz M, Cohen SM, Lewkowicz AA, Amsalem H, Haj Yahya R, Levitt L, Yagel S. [PROLONGED SECOND STAGE OF LABOR: CAUSES AND OUTCOMES]. Harefuah. 2018 Nov;157(11):685-690. Hebrew.

Central Study Contacts

Gamal Omar hussein, Specialist

CONTACT

Rasha Ahmed Kamel, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator (Obgyn specialist)

Study Record Dates

First Submitted

April 23, 2021

First Posted

April 27, 2021

Study Start

May 1, 2021

Primary Completion

May 1, 2022

Study Completion

June 1, 2022

Last Updated

April 29, 2021

Record last verified: 2021-04