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

Vaginal Delivery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03264599
• Other study ID #: 12
• Status: Completed
• Phase: N/A
• First received: August 25, 2017
• Last updated: August 25, 2017
• Start date: July 11, 2016
• Est. completion date: August 20, 2017

Study information

• Verified date: August 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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.

The sonographer was not involved in the patient's care and the managing obstetrician was blinded to the ultrasound findings and the occiput-spine angle. For each patient of the study group, the progress of labor using a partogram ( cervical dilation ,effacement ,consistency, position and station ) and the mode of delivery were assessed retrospectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 20, 2017
• Est. primary completion date: July 21, 2017
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Age between 18 & 35 years old.

2. BMI is less than 30

3. The gestational age between 37- 42 weeks. (calculated by LMP or 1st trimesteric U/S)

4. Singleton pregnancy.

5. History of one vaginal delivery.

6. Occiputo anterior position.

7. Active phase of first stage of labor.

Exclusion Criteria:

1. Age (below18 or above 35).

2. Primigravida.

3. Occiputo posterior position.

4. Indications of cesarean section like malpresentations , macrosomia , placenta previa, previous cesarean section .

5. Multiple gestation.

6. Medical disorders like hypertension, DM, liver or renal diseases

Related Conditions & MeSH terms

• Vaginal Delivery

Intervention

Device:
• transabdominal ultrasound
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

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vaginal delivery		24 hours