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

Completed

• Conditions: Vaginal Delivery
• Interventions: Device: transabdominal ultrasound

• Registration Number: NCT03264599
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2016-07-11
• Primary Completion: 2017-07-21
• Status Verified: 2017-08
• Study Completion: 2017-08-20
• Study First Submitted: 2017-08-25
• Study First Submitted QC: 2017-08-25
• Last Update Submitted: 2017-08-25
• Study First Posted: 2017-08-29
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
occiput-spine angle > or = 126	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 \> or = 126) will be performed to quantify the degree of fetal head flexion in respect to the trunk
occiput-spine angle<126	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 \< 126) will be performed to quantify the degree of fetal head flexion in respect to the trunk

Primary Outcome Measures

Name	Time	Method
vaginal delivery	24 hours

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt