Cervical Length and Bishop Score in Preinduction Cervical Assessment Prior to Induction of Labor

Comparison Between Sonographic Cervical Length and Bishop Score in Preinduction Cervical Assessment Prior to Induction of Labor as Regards Induction Success

Comparison between Sonographic Cervical Length and Bishop Score in Preinduction Cervical Assessment prior to induction of labor as regards induction success.

Study Overview

• Status: Completed
• Conditions: Cervical Dystocia
• Intervention / Treatment: Other: Bishop score; Other: cervical length

Detailed Description

Type of the study:

assessment of accuracy of diagnostic test.

Study setting:

The study will be performed at Ain Shams university Maternity hospital on nulliparous women at term admitted to causality for induction of labor.

Study population:

The study will be held on 200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital.

All patients will have cervical assessment by modified Bishop score and cervical length measurement by ultrasound.

Plan for induction of labor:

• Detailed and careful history will be taken from the participants as follows:

  1. Personal history: including name, age, occupation, residence and special habits of medical importance.
  2. Obstetric history: including gestational age and regular antenatal care.
  3. Past history: including any medical disorder e.g Diabetes mellitus, hypertension or any surgical procedure.
  4. History of present pregnancy: duration of pregnancy from last menstrual period, any complications occurred or any medication used during pregnancy.

• Examination of the participants:

  1. General examination: level of consciousness, vital data, complexion.
  2. Abdominal examination: fundal level, lie of the fetus, detection of any uterine contractions and fetal heart rate.
  3. Pelvic Examination : presenting part, presence of ruptured membranes and cervical assessment as regard cervical dilation, effacement, station and presenting part to calculate the modified Bishop Score.
• Investigations: complete blood count, blood group, non stress test.
• All women will have trans-vaginal ultrasound sound for assessment of cervical length.

• Protocol of trans-vaginal ultrasound will be as follows:

  1. Patient will be asked to void.
  2. Vaginal probe will be inserted using direct visualization.
  3. Identification of bladder and fetal presenting part.
  4. Identification of abnormal findings as placenta previa or absence of fetal heart motion.
  5. Identification of mid-line sagittal plane of the cervix and looking in the proximal one third of the image for the internal cervical os then pulling back the probe until the lightest touch provides good image of the cervical canal and moving the probe slightly to get the best long axis of the cervix then measuring the cervical length three times by placing the calibers appropriately and recording the distance between internal and external os then at last recording the measurement of the best image .
• If cervical length assessed by trans-vaginal ultrasound is less than 28 mm or modified Bishop Value is less than 7, the patient will receive 3mg prostaglandin E2 for pre-induction cervical ripening to be repeated after 6 hours with maximum of 2 doses. If failed cervical ripening, Cesarean section will be done.
• All Patients will be tested by antepartum fetal heart monitoring "Non stress test".This will be considered reactive if there are two or more fetal heart rate accelerations peaking at least by 15 beats/min above the baseline and lasting for 15 seconds or more from baseline, within a 20 minutes period, with or without fetal movement felt by the mother. A non-reactive tracing will be one without sufficient fetal heart rate accelerations over a 40 minutes period. Any patient with non-reassuring non stress test will be excluded.
• Successful induction will be defined as vaginal delivery within 24 hours.
• Failed induction after 24 hours will indicate lower segment cesarean section. Failed induction will be defined as an inability to achieve the active phase of labor corresponding to a cervical dilatation ≥4 cm within 12 hours of initiating oxytocin. Failure of progress was defined as no cervical dilatation during the active phase of labor for at least 2 hours or no descent of the fetal head during the second stage of labor for at least 1 hour despite adequate uterine contraction. This will be considered an indication for cesarean delivery.
• No further induction agent will be given when uterine contractions reach frequency of three in ten minutes each lasting 30-60 seconds with cervical changes. Amniotomy and oxytocin augmentation will begin when cervical dilation becomes > 3 cm.
• Oxytocin infusion will be prepared by placing 5 IU ampoule in 500 ml Ringer or Saline to achieve concentration of 10 ml\minute.
• The rate of infusion will be started at a rate of 5 miu/ml (about 10 drops per minute) and will be increased at same increment every 20 minutes according to uterine contractions.
• When the patient become in the active phase of labor, vaginal examination will be repeated every 1-2 hours to know the rate of cervical dilation.
• If patient requests pain relieve, epidural analgesia will be used.
• Fetal heart rate will be recorded every half an hour.
• Labor progress will be plotted on partogram.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 38 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital

Description

Inclusion Criteria:

1. Nulliparous patients.
2. Singleton pregnancy.
3. Living fetus with cephalic presentation.
4. Absence of labor pain.
5. Gestational age 37-42 weeks.
6. No previous uterine surgical procedures.
7. No Liquor abnormalities.
8. Fetal weight less than 4 kilograms.

Exclusion Criteria:

1. Non-vertex presentation.
2. Previous uterine surgery.
3. Multiple pregnancy.
4. Fetal or maternal complications that might cause cesarean section.
5. Liquor abnormalities.
6. Fetal weight more than 4 kilograms.
7. Abnormal umbilical artery Doppler indices or non-stress test.
8. Asthmatic patients or women with allergy to prostaglandins.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Induction of labor; 200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.	Other: Bishop score; calculation of modified Bishop score in numbers by digital vaginal examination; Other: cervical length; measuring cervical length by trans-vaginal ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical Length Prior to Labor Induction	median cervical length measured by transvaginal ultrasound in centimetres	24 hours
Bishop Score Prior to Induction of Labor	median Bishop score assessed by digital vaginal examination as follows: Cervical dilatation in centimeters will be given a score of zero if closed, a score of 1 if 1-2 cm dilated, a score of 2 if 3-4 cm dilated and a score of 3 if 5 cm or more dilataion.; Effacement of the cervix will be given a score of zero if 0-30%, a score of 1 if 40-50%, a score of 2 if 60-70% and a score of 3 if 80% or more.; Station of fetal head will be given a score of zero if -3, a score of 1 if -2, a score of 2 if -1 to zero and a score of 3 if 1 or more.; Consistency of the cervix will be given a score of zero if firm, a score of 1 if medium and a score of 2 if soft.; 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. Note that a score more than 10 means patient is in labor not needing induction of labor.	72 hours

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: February 23, 2016
• First Submitted That Met QC Criteria: February 26, 2016
• First Posted (Estimate): February 29, 2016

Study Record Updates

• Last Update Posted (Estimate): November 6, 2016
• Last Update Submitted That Met QC Criteria: September 19, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Dystocia
• Other Study ID Numbers: sonographic cervical length

Plan for Individual participant data (IPD)

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