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

NCT ID: NCT03264599

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-11
• Study Completion Date: 2017-08-20

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

Detailed 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.

Conditions

Vaginal Delivery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

transabdominal ultrasound

Intervention Type: 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<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

transabdominal ultrasound

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Maged

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

kasr Alainy medical school

Locations

Kasr Alainy medical school

Cairo, , Egypt

Countries

Egypt

Other Identifiers

12

Identifier Type: -

Identifier Source: org_study_id