Predicting the Outcomes of Labor Induction

Completed

• Conditions: Induction of Labor Affected Fetus / Newborn

• Registration Number: NCT03175406
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study Start: 2016-04-01
• Primary Completion: 2017-04-01
• Study Completion: 2017-04-01
• Status Verified: 2017-05
• Study First Submitted: 2017-05-28
• Study First Submitted QC: 2017-06-01
• Last Update Submitted: 2017-06-01
• Study First Posted: 2017-06-05
• Last Update Posted: 2017-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the occurrence of active labor	within one day of labor induction	successful labor induction(IOL)

Secondary Outcome Measures

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