CClinicalTrials.gg
CompletedNCT03264599Updated Aug 29, 2017

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

An observational study in Vaginal Delivery, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2017-08-29.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 35 Years
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Vaginal Delivery
03

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
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

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Devicetransabdominal 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

05

What researchers measure

Primary outcomes

  1. vaginal delivery

    Time frame: 24 hours

06

Study locations

1 site
  • Kasr Alainy medical school
    Cairo, 12151, Egypt
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03264599
Lead sponsor
Cairo University
Responsible party
Ahmed Maged (Professor, Cairo University) — Principal investigator
First posted
Aug 29, 2017
Start date
Jul 11, 2016
Primary completion
Jul 21, 2017
Completion
Aug 20, 2017
Last update
Aug 29, 2017

Study contacts

Ahmed Maged, MD
principal investigator · kasr Alainy medical school

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion