Intrapartum Ultrasonography in Evaluation of the Progress of Labor

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05823610
Collaborator
(none)
300
27

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ultrasound

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Intrapartum Ultrasonography in Evaluation of the Progress of Labor
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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
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).

Outcome Measures

Primary Outcome Measures

  1. compare the intrapartum sonographic parameters between women who had spontaneous vaginal delivery (SVD) vs those who required CS [one hour]

    Ultrasound evaluation of the parameters of progress of labour

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Mohamed Abbas, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05823610
Other Study ID Numbers:
  • IPUS
First Posted:
Apr 21, 2023
Last Update Posted:
Apr 21, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 21, 2023