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Modifying Cervical Bishop Scoring System

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ClinicalTrials.gov Identifier: NCT02314260
Recruitment Status : Completed
First Posted : December 11, 2014
Results First Posted : January 16, 2015
Last Update Posted : January 16, 2015
Sponsor:
Information provided by (Responsible Party):
Ahmed M.Kamel, Kasr El Aini Hospital

Brief Summary:
To have an early more precise way to predict failed induction in patients undergoing elective termination of pregnancy & those more likely to undergo caesarian section,this will Spare patients with decreased chances of favorable induction a long and exhausting trial of labour with increased probability of complications and an emergency caesarian

Condition or disease Intervention/treatment
Failed Induction of Labor Other: bishop score calculation Other: Trans-vaginal ultrasound Other: Modified bishop score calculation Procedure: labour induction

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bishop Score; Are Further Modifications Needed?
Study Start Date : July 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Group/Cohort Intervention/treatment
Labour Induction
80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.
Other: bishop score calculation
Assessment of bishop score by vaginal examination

Other: Trans-vaginal ultrasound
trans-vaginal ultrasound assessment of cervical length.

Other: Modified bishop score calculation
using the cervical length and the original bishop score to calculate modified bishop score

Procedure: labour induction
Induction of labor was carried out as per our hospital's standard protocol.




Primary Outcome Measures :
  1. Area Under Receiver Operating Characteristic Curve (ROC) for Modified Bishop Score [ Time Frame: 5 months ]
    to predict failed induction and comparing it to the area under curve for bishop score to find out which test is more accurate in predicting caesarean section, The positive actual state is failed induction and performing Caesarean Section.The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity). So as the numbers approaches 1, induction fails, the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).


Secondary Outcome Measures :
  1. Area Under Curve for The Bishop Score [ Time Frame: 5 months ]
    to predict failed induction and comparing it to the area under curve for modified bishop score to find out which test is more accurate in predicting caesarean section, The positive actual state is failed induction and performing Caesarean Section. The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity), So as the numbers approaches 1, induction fails, the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).

  2. Cut Off Value for The Modified Bishop Score [ Time Frame: 5 months ]
    the value at which there a high sensitivity and specificity to predict failed labour induction

  3. Cut Off Value for Bishop Score [ Time Frame: 5 months ]
    the value at which there a high sensitivity and specificity to predict failed labour induction



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Ages Eligible for Study:   20 Years to 34 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
80 primigravidas undergoing induction of labour at our hospital in a prospective study were subjected to history taking, examination, investigations & ultrasonography. Indication for pregnancy termination was explained to each patient and a written consent was obtained.
Criteria

Inclusion Criteria:

  1. Primigravida Singleton pregnancy with mature fetus at term indicated for termination of pregnancy.
  2. Cephalic presentation.
  3. Medical indications for termination of pregnancy e.g.: Pre-eclampsia, uncontrolled diabetes at term..e.t.c,
  4. Post-term pregnancy.
  5. Fetal indication: signs of fetal compromise e.g.: decreased biophysical profile, poor umbilical Doppler indices, diminished liquor.
  6. premature rupture of membranes (PROM) not going into spontaneous labor within 24 hours since onset.
  7. Intrauterine fetal death (IUFD).

Exclusion Criteria:

  1. they had true labor pains or clear onset of labor as diagnosed by cervical changes.
  2. Previous uterine surgery (scared uterus).
  3. Cephalo-pelvic disproportion.
  4. Mal-presentations
  5. Severe oligo-hydramnios i.e.: amniotic fluid index Less than 5.
  6. Twin pregnancy.
  7. Fetal macrosomia. —Growth beyond a specific threshold (weight above 4000g) 8) Placenta previa.

9) Fetal bradycardia in case of living fetus.


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): NCT02314260


Locations
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Egypt
11562
Garden City, Cairo, Egypt, 11562
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Principal Investigator: Ahmed M Kamel, M.D Lecturer of obstetrics & Gynecology

Publications:
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Responsible Party: Ahmed M.Kamel, Lecturer Of obstetrics & Gynecology, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT02314260     History of Changes
Other Study ID Numbers: A13802022
First Posted: December 11, 2014    Key Record Dates
Results First Posted: January 16, 2015
Last Update Posted: January 16, 2015
Last Verified: January 2015

Keywords provided by Ahmed M.Kamel, Kasr El Aini Hospital:
labour induction
cervical length
trans-vaginal assessment of cervical length
Bishop score