Intrapartum Ultrasonography in Evaluation of the Progress of Labor

NCT ID: NCT05823610

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2025-09-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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).

ultrasound

Intervention Type: 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).

Interventions

ultrasound

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).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Abbas

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IPUS

Identifier Type: -

Identifier Source: org_study_id