Predicting the Outcomes of Labor Induction

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175406
• Other study ID #: ASU maternity hospital
• Status: Completed
• Phase: N/A
• First received: May 28, 2017
• Last updated: June 1, 2017
• Start date: April 1, 2016
• Est. completion date: April 1, 2017

Study information

• Verified date: May 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn

Intervention

Diagnostic Test:
• Manipal cervical scoring system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the occurrence of active labor	successful labor induction(IOL)	within one day of labor induction
Secondary	The interval from onset of induction to active labor	duration of induction	24 hours
Secondary	Successful vaginal delivery		48 hours
Secondary	The need for cesarean delivery (CS)	indication of CS (fetal distress ,failed induction,...)	24 hours
Secondary	maternal and fetal complication associated with IOL	tachy systole, postpartum hemorrhage, fetal distress	during induction ,labor, and 24 hours postpartum