N/A
N=80
Modifying Cervical Bishop Scoring System
Failed Induction of Labor
Bottom Line
View on ClinicalTrials.gov: NCT02314260 ↗Enrolled (actual)
80
Serious AEs
22.5%
Results posted
Jan 2015
Primary outcome: Primary: Area Under Receiver Operating Characteristic Curve (ROC) for Modified Bishop Score — 0.916 probability — p=0.000
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- bishop score calculation (Other); Trans-vaginal ultrasound (Other); Modified bishop score calculation (Other); labour induction (Procedure)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Kasr El Aini Hospital
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under Receiver Operating Characteristic Curve (ROC) for Modified Bishop Score |
0.916 | 0.000 sig |
| SECONDARY Area Under Curve for The Bishop Score |
0.806 | 0.000 sig |
| SECONDARY Cut Off Value for The Modified Bishop Score |
4.5 | 0.000 sig |
| SECONDARY Cut Off Value for Bishop Score |
5.5 | 0.000 sig |
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
Eligibility Criteria
Inclusion Criteria
- Primigravida Singleton pregnancy with mature fetus at term indicated for termination of pregnancy.
- Cephalic presentation.
- Medical indications for termination of pregnancy e.g.: Pre-eclampsia, uncontrolled diabetes at term..e.t.c,
- Post-term pregnancy.
- Fetal indication: signs of fetal compromise e.g.: decreased biophysical profile, poor umbilical Doppler indices, diminished liquor.
- premature rupture of membranes (PROM) not going into spontaneous labor within 24 hours since onset.
- Intrauterine fetal death (IUFD).
Exclusion Criteria
- they had true labor pains or clear onset of labor as diagnosed by cervical changes.
- Previous uterine surgery (scared uterus).
- Cephalo-pelvic disproportion.
- Mal-presentations
- Severe oligo-hydramnios i.e.: amniotic fluid index Less than 5.
- Twin pregnancy.
- Fetal macrosomia. -Growth beyond a specific threshold (weight above 4000g) 8) Placenta previa.
- Fetal bradycardia in case of living fetus.
Data sourced from ClinicalTrials.gov (NCT02314260). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.