Modifying Cervical Bishop Scoring System

NCT02314260 | Completed Results

• 1 other identifier: A13802022
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Failed Induction of Labor

Keywords

labour induction; cervical length; trans-vaginal assessment of cervical length; Bishop score

Outcome Measures

Primary Outcomes (1)

• Area Under Receiver Operating Characteristic Curve (ROC) for Modified Bishop Score

  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).

  5 months

Secondary Outcomes (3)

• Area Under Curve for The Bishop Score

  5 months

• Cut Off Value for The Modified Bishop Score

  5 months

• Cut Off Value for Bishop Score

  5 months

Study Arms (1)

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; Other: Trans-vaginal ultrasound; Other: Modified bishop score calculation; Procedure: labour induction

Interventions

bishop score calculation OTHER

Assessment of bishop score by vaginal examination

Labour Induction

Trans-vaginal ultrasound OTHER

trans-vaginal ultrasound assessment of cervical length.

Labour Induction

Modified bishop score calculation OTHER

using the cervical length and the original bishop score to calculate modified bishop score

Labour Induction

labour induction PROCEDURE

Induction of labor was carried out as per our hospital's standard protocol.

Labour Induction

Eligibility Criteria

• Age: 20 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

11562

Ḩadā’iq al Qubbah, Cairo Governorate, 11562, Egypt

Location

Related Publications (1)

• BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.

  PMID: 14199536 BACKGROUND

MeSH Terms

Interventions

Labor, Induced

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr Ahmed Kamel
• Organization: kasr EL alini

dr.ahmed.m.kamel@gmail.com

0201120022332

Study Officials

• Ahmed M Kamel, M.D

  Lecturer of obstetrics & Gynecology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Of obstetrics & Gynecology

Study Record Dates

• First Submitted: December 6, 2014
• First Posted: December 11, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 16, 2015
• Results First Posted: January 16, 2015

Record last verified: 2015-01

Locations

EG (1)