Intrapartum Ultrasonography in Evaluation of the Progress of Labor

NCT05823610 | Unknown

• 1 other identifier: IPUS
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The optimal management of the second stage of labor is a subject of an ongoing debate. It is well established that prolonged second stage of labor is associated with increased maternal and neonatal morbidity. Diagnosing the onset of labour is one of the most critical and complex judgments made by care providers in the delivery room. Measurement of cervical dilatation is considered the most crucial parameter for labour progress during childbirth and the main reason for doing digital vaginal examination (DVE) in women with signs of labour onset. DVE was the most common method for measuring cervical dilatation in the past and has been the gold standard for assessing labour progress. However, it can be subjective, inaccurate, and uncomfortable for women. Also, only 50% of assessments are accurate, and there is an increased risk of infection with frequent DVE. Therefore, vaginal examination cannot be a correct scale for measuring cervical dilatation, mainly when done by different examiners. Because of the poor reliability and pain associated with DVE, the use of intrapartum ultrasound to measure cervical dilation has been suggested as an alternative method. Abdominal, vaginal, trans-labial, and trans-perineal 2D and 3D ultrasounds have been used to measure cervical dilatation during labour.

Conditions

Progress pf Labor

Outcome Measures

Primary Outcomes (1)

• compare the intrapartum sonographic parameters between women who had spontaneous vaginal delivery (SVD) vs those who required CS

  Ultrasound evaluation of the parameters of progress of labour

  one hour

Study Arms (1)

study group

The ultrasound parameters to be collected included the angle of progression, head-perineum distance and head-symphysis distance at rest and while pushing during contraction and the data between measurements taken at rest and while pushing. Also anatomical scanning for the episiotomy, perineal tears and obstetric anal sphincter injuries (OASI), also trauma to the levator ani muscle. All demographic, clinical and ultrasound variables were compared between women who had a spontaneous vaginal delivery (SVD) and those who eventually had an operative delivery (OD), vacuum -assisted or cesarean section (CS).

Diagnostic Test: ultrasound

Interventions

ultrasound DIAGNOSTIC_TEST

The ultrasound parameters to be collected included the angle of progression, head-perineum distance and head-symphysis distance at rest and while pushing during contraction and the data between measurements taken at rest and while pushing. Also anatomical scanning for the episiotomy, perineal tears and obstetric anal sphincter injuries (OASI), also trauma to the levator ani muscle. All demographic, clinical and ultrasound variables were compared between women who had a spontaneous vaginal delivery (SVD) and those who eventually had an operative delivery (OD), vacuum -assisted or cesarean section (CS).

study group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

women presented in labor

You may qualify if:

• Primigravida patients
• At the onset of active phase
• Cephalic vertex presentation
• Estimated Fetal Weight 3Kg - 4Kg
• Gestational Age ≥37 weeks

You may not qualify if:

• Multiple Pregnancy
• Patients refused to participate in our study
• Induced labor
• Any Obstetrical Complication or Disease
• Malpresentation

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: April 21, 2023
• Study Start: June 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 21, 2023

Record last verified: 2023-04