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OpenTrials
Completed

NCT Number: NCT03175406

Predicting the Outcomes of Labor Induction

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

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

About this study

preinduction cervical assessment using The Burnett modification of Bishop score with

  • 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.
  • 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.
  • 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.
  • 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.
  • 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:

  • 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.
  • 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.
  • 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.
  • cervical position and shape will be given a score of zero if curved, a score of 2 if straight
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton gestation at 37 completed weeks or greater .
  • Cephalic presentation.
  • Longitudinal lie.
  • Living fetus.
  • Intact membrane

Exclusion criteria

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

Treatment and study plan

Manipal cervical scoring system

Diagnostic Test

Other names: The Burnett modification of Bishop score

Primary outcomes

  1. the occurrence of active labor

    Time frame: within one day of labor induction

    successful labor induction(IOL)

Secondary outcomes

  1. The interval from onset of induction to active labor

    Time frame: 24 hours

    duration of induction

  2. Successful vaginal delivery

    Time frame: 48 hours

  3. The need for cesarean delivery (CS)

    Time frame: 24 hours

    indication of CS (fetal distress ,failed induction,...)

  4. maternal and fetal complication associated with IOL

    Time frame: during induction ,labor, and 24 hours postpartum

    tachy systole, postpartum hemorrhage, fetal distress

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 5, 2017
Registry last updated
Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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