Predicting the Outcomes of Labor Induction

Comparing the Accuracy of Manipal Cervical Scoring System and Modified Bishop Score in Predicting Successful Induction of Labor

Pre induction assessment using bishop scoring system and Manipal cervical scoring system performed on 105 pregnant females

Study Overview

• Status: Completed
• Conditions: Induction of Labor Affected Fetus / Newborn
• Intervention / Treatment: Diagnostic test: Manipal cervical scoring system

Detailed Description

preinduction cervical assessment using The Burnett modification of Bishop score with

1. Cervical dilatation in centimeters will be given a score of zero if dilatation less than 1cm, a score of 1 if 1-2 cm dilated, a score of 2 if more than 2 cm dilataion.
2. Length of the cervix will be given a score of zero if more than 2 cm, a score of 1 if 1-2 cm, a score of 2 if less than 1 cm.
3. Station of fetal head will be given a score of zero if -2 or higher , a score of 1 if -1, a score of 2 if zero or lower.
4. Consistency of the cervix will be given a score of zero if firm, a score of 1 if soft and a score of 2 if soft and stretchable.
5. Position of the cervix will be given a score of zero if posterior, a score of 1 if mid position and a score of 2 if anterior. So, a total score (sum of all scores) of zero at a minimum to 10 at a maximum can be estimated.

and also preinduction cervical assessment using transvaginal ultrasound and Manipal system where:

1. Length of the cervix will be given a score of zero if more than 3 cm, a score of 1 if 2-3 cm, a score of 2 if less than 2 cm.
2. Length of the funnel will be given a score of zero if absent, a score of 1 if ≤ 0.5 cm, a score of 2 if more than 0.5 cm.
3. width of the funnel will be given a score of zero if absent, a score of 1 if ≤ 0.5 cm, a score of 2 if more than 0.5 cm.
4. cervical position and shape will be given a score of zero if curved, a score of 2 if straight
5. Distance of presenting part to external os will be given a score of zero if more than 3 cm, a score of 1 if 2-3 cm, a score of 2 if less than 2 cm

• Study Type: Observational
• Enrollment (Actual): 105

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

105 females with singleton term pregnancy undergoing induction of labor

Description

Inclusion Criteria:

1. Singleton gestation at 37 completed weeks or greater .
2. Cephalic presentation.
3. Longitudinal lie.
4. Living fetus.
5. Intact membrane

Exclusion Criteria:

1. Previous cesarean delivery or rupture uterus.
2. Antepartum hemorrhage including (abruptio placenta, placenta previa or vasa previa).
3. Abnormal fetal lie or presentation.
4. Pervious uterine surgery as myomectomy.
5. Category II, III non stress test.
6. Pelvic structural deformity.
7. Intrautrine growth retardation or macrosomia (estimated fetal weight ˃ than 4kg).
8. Patients who received any pre induction ripening.
9. Active genital herpes.
10. Invasive cervical carcinoma

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the occurrence of active labor	successful labor induction(IOL)	within one day of labor induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The interval from onset of induction to active labor	duration of induction	24 hours
Successful vaginal delivery		48 hours
The need for cesarean delivery (CS)	indication of CS (fetal distress ,failed induction,...)	24 hours
maternal and fetal complication associated with IOL	tachy systole, postpartum hemorrhage, fetal distress	during induction ,labor, and 24 hours postpartum

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Gasser M El-Bishry, MD,FRCOG, Professor; Study Director: Ihab F Allam, MD, Professor

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: May 28, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): June 5, 2017
• Last Update Submitted That Met QC Criteria: June 1, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: ASU maternity Hospital (Registry Identifier: ASU maternity Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No