NCT06177080

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 20, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

December 11, 2023

Last Update Submit

September 14, 2024

Conditions

Keywords

head symphysis distanceangle of progressionsonopartograph

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Definitions of active phase angle of progression, head symphysis distance and examination findings

OTHER

Definitions of active phase AOP and HSD and examination findings measured in each period according to the type of birth

Other: transperineal ultrasound

Interventions

descent angle and head symphysis distances by transperineal ultrasound of active phase of labor women.

Definitions of active phase angle of progression, head symphysis distance and examination findings

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • multiparous pregnancy
  • active phase in labor
  • vertex position

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nefise Nazlı YENIGUL

Bursa, 16110, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: 30 nulliparous and 70 multiparous total 100 singleton pregnant women measured descent angle and head symphysis distances by transperineal ultrasound in the active phase of labor.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Assistant Professor Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

December 11, 2023

First Posted

December 20, 2023

Study Start

December 1, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations