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

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ClinicalTrials.gov Identifier: NCT03264599
Recruitment Status : Completed
First Posted : August 29, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, 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

Condition or disease Intervention/treatment
Vaginal Delivery Device: transabdominal ultrasound

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.


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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : July 11, 2016
Actual Primary Completion Date : July 21, 2017
Actual Study Completion Date : August 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
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
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
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




Primary Outcome Measures :
  1. vaginal delivery [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264599


Locations
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Egypt
Kasr Alainy medical school
Cairo, Egypt, 12151
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged, MD kasr Alainy medical school

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Responsible Party: Ahmed Maged, Professor, Cairo University
ClinicalTrials.gov Identifier: NCT03264599     History of Changes
Other Study ID Numbers: 12
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No