Transperineal Ultrasound and the Place of Sonopartograph in Travay Follow-up in Term Pregnancy

Evaluation of the Active Phase of Delivery by Transperineal Ultrasound and the Place of Sonopartograph in Travay Follow-up in Term Pregnancy

Investigators aimed to determine the progression of the descent angle and head symphysis distance measured by intrapartum transperineal ultrasound as an alternative to vaginal examination and bishop score, according to time and cervical dilatation and to draw a sonopartograph as a new indicator also aimed to evaluate the success of the use of transperineal ultrasound in the active phase of labor in predicting prolonged labor, duration and mode of of delivery.

Study Overview

• Status: Completed
• Conditions: Intrapartum Transperineal Ultrasound
• Intervention / Treatment: Other: transperineal ultrasound

Detailed Description

Descent angle and head symphysis distances by transperineal ultrasound of pregnant women who are in the active phase of labor was measured hourly in the first phase of the active phase (the period from 4 cm to full dilation of the cervical opening); every 15 minutes in the second phase of the active phase (time from full dilation to delivery of the baby) Cervical dilatation and head levels were noted by simultaneous digital vaginal examination. The physician who performed the imaging and the physician who made the vajinal examination worked independently of each other and did not see each other's results.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16110
    • Nefise Nazlı YENIGUL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• multiparous pregnancy
• active phase in labor
• vertex position

Exclusion Criteria:

• multiple pregnancy
• BMI over 35
• preterm labor
• congenital anomalies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Definitions of active phase angle of progression, head symphysis distance and examination findings; Definitions of active phase AOP and HSD and examination findings measured in each period according to the type of birth	Other: transperineal ultrasound; descent angle and head symphysis distances by transperineal ultrasound of active phase of labor women.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transperineal ultrasound instead of digital vaginal examination	use of transperineal ultrasound in the active phase of labor in predicting prolonged labor, duration and mode of delivery.	7 months

Collaborators and Investigators

• Sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: angle of progression; head symphysis distance; sonopartograph; intrapartum transperineal ultrasound
• Other Study ID Numbers: 2011-KAEK-252021/10-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No