NCT05206409

Brief Summary

In the past years, numerous studies have been published on the use of ultrasound during labor, showing this is an effective, accurate and objective tool for the assessment of the fetal head position and station. Literature affirmed that traditional transvaginal digital examination is highly subjective and dependent on the operator's experience. On the contrary, the use of intrapartum suprapubic transabdominal ultrasound can improve accuracy in determination of fetal head position and the precise knowledge of the location of specific fetal head landmarks in relationship to maternal pelvis. Intrapartum ultrasound will assist obstetricians in the diagnosis of normal labor progression, suggesting when medical and or operative intervention should be taken in case of complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
382

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

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

First Submitted

Initial submission to the registry

January 21, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

January 25, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

October 17, 2023

Status Verified

January 1, 2022

Enrollment Period

1.6 years

First QC Date

January 21, 2022

Last Update Submit

October 16, 2023

Conditions

Prolonged Labor

Outcome Measures

Primary Outcomes (1)

  • Mode of delivery

    Correlation between fetal head position and mode of delivery

    6 months

Interventions

UltrasoundDIAGNOSTIC_TEST

Fetal head position determination using ultrasound

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Nulliparous women with delayed first stage of Labor

You may qualify if:

  • nulliparous women
  • Singleton pregnancy
  • prolonged first stage of Labor
  • average fetal weight
  • gestational age at or beyond 37 weeks

You may not qualify if:

  • IUFD
  • malpresentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams Maternity Hospital

Cairo, 002, Egypt

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2022

First Posted

January 25, 2022

Study Start

January 25, 2022

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

October 17, 2023

Record last verified: 2022-01

Locations

EG(1)