Measurement of the Fetal Occiput-spine Angle During the First Stage of Labor as Predictor of the Outcome of Labor

NCT03264599 | Completed DMC

• 1 other identifier: 12
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the fetal head and upper spine was acquired and stored in the ultrasound machine. On this image, the offline measurement of the angle formed by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle) will be performed to quantify the degree of fetal head flexion in respect to the trunk

Conditions

Vaginal Delivery

Outcome Measures

Primary Outcomes (1)

• vaginal delivery

  24 hours

Study Arms (2)

occiput-spine angle > or = 126

2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the fetal head and upper spine was acquired and stored in the ultrasound machine. On this image, the offline measurement of the angle formed by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle \> or = 126) will be performed to quantify the degree of fetal head flexion in respect to the trunk

Device: transabdominal ultrasound

occiput-spine angle<126

2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the fetal head and upper spine was acquired and stored in the ultrasound machine. On this image, the offline measurement of the angle formed by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle \< 126) will be performed to quantify the degree of fetal head flexion in respect to the trunk

Device: transabdominal ultrasound

Interventions

transabdominal ultrasound DEVICE

2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the fetal head and upper spine was acquired and stored in the ultrasound machine. On this image, the offline measurement of the angle formed by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle) will be performed to quantify the degree of fetal head flexion in respect to the trunk

occiput-spine angle > or = 126; occiput-spine angle<126

Eligibility Criteria

• Age: 18 Years - 35 Years
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

a total of 400 women with gestational age 37 weeks or more and history of one vaginal delivery at least

You may qualify if:

• Age between 18 \& 35 years old.
• BMI is less than 30
• The gestational age between 37- 42 weeks. (calculated by LMP or 1st trimesteric U/S)
• Singleton pregnancy.
• History of one vaginal delivery.
• Occiputo anterior position.
• Active phase of first stage of labor.

You may not qualify if:

• Age (below18 or above 35).
• Primigravida.
• Occiputo posterior position.
• Indications of cesarean section like malpresentations , macrosomia , placenta previa, previous cesarean section .
• Multiple gestation.
• Medical disorders like hypertension, DM, liver or renal diseases

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

Study Officials

• Ahmed Maged, MD

  kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 29, 2017
• Study Start: July 11, 2016
• Primary Completion: July 21, 2017
• Study Completion: August 20, 2017
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

EG (1)