Clinical trial NCT03175406: Predicting the Outcomes of Labor Induction
Official title: Comparing the Accuracy of Manipal Cervical Scoring System and Modified Bishop Score in Predicting Successful Induction of Labor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Induction of Labor Affected Fetus / Newborn
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 105
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 105 females with singleton term pregnancy undergoing induction of labor

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

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

Eligibility criteria: 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

Primary outcomes:
measure: the occurrence of active labor
timeFrame: within one day of labor induction
Secondary outcomes:
measure: The interval from onset of induction to active labor
timeFrame: 24 hours
measure: Successful vaginal delivery
timeFrame: 48 hours
measure: The need for cesarean delivery (CS)
timeFrame: 24 hours
measure: maternal and fetal complication associated with IOL
timeFrame: during induction ,labor, and 24 hours postpartum
Other outcomes:
Locations:
Study officials:
affiliation: Professor
name: Gasser M El-Bishry, MD,FRCOG
role: STUDY_CHAIR
affiliation: Professor
name: Ihab F Allam, MD
role: STUDY_DIRECTOR
References: