Cervical DystociaNCT02694315
Cervical Length and Bishop Score in Preinduction Cervical Assessment Prior to Induction of Labor
An observational study of Cervical Dystocia, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Comparison between Sonographic Cervical Length and Bishop Score in Preinduction Cervical Assessment prior to induction of labor as regards induction success. Read more about this study
- Who is it for?
- Ages 17 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Dystocia
- What is being tested?
- Bishop score and cervical length
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2014to Mar 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- Nulliparous patients.
- Singleton pregnancy.
- Living fetus with cephalic presentation.
- Absence of labor pain.
- Gestational age 37-42 weeks.
- No previous uterine surgical procedures.
- No Liquor abnormalities.
- Fetal weight less than 4 kilograms.
Who cannot join
- Non-vertex presentation.
- Previous uterine surgery.
- Multiple pregnancy.
- Fetal or maternal complications that might cause cesarean section.
- Liquor abnormalities.
- Fetal weight more than 4 kilograms.
- Abnormal umbilical artery Doppler indices or non-stress test.
- Asthmatic patients or women with allergy to prostaglandins.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- Personal history: including name, age, occupation, residence and special habits of medical importance.
- Obstetric history: including gestational age and regular antenatal care.
- Past history: including any medical disorder e.g Diabetes mellitus, hypertension or any surgical procedure.
- History of present pregnancy: duration of pregnancy from last menstrual period, any complications occurred or any medication used during pregnancy.
- Examination of the participants:
- General examination: level of consciousness, vital data, complexion.
- Abdominal examination: fundal level, lie of the fetus, detection of any uterine contractions and fetal heart rate.
- 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:
- Patient will be asked to void.
- Vaginal probe will be inserted using direct visualization.
- Identification of bladder and fetal presenting part.
- Identification of abnormal findings as placenta previa or absence of fetal heart motion.
- 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.
- Conditions
- Cervical Dystocia
- Being tested
- Bishop score, cervical length
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bishop scoreOther
calculation of modified Bishop score in numbers by digital vaginal examination
cervical lengthOther
measuring cervical length by trans-vaginal ultrasound
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Bishop score; Other: cervical length |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Length Prior to Labor Induction
median cervical length measured by transvaginal ultrasound in centimetres
Measured: 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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startOct 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical DystociaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694315
- Sponsor's protocol ID
- sonographic cervical length
- Status last verified
- Sep 2016
- First submitted
- 23 Feb 2016
- Last updated
- 7 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Sonographic Cervical Length and Bishop Score in Preinduction Cervical Assessment Prior to Induction of Labor as Regards Induction Success
- ClinicalTrials.gov ID
- NCT02694315
- Acronym / sponsor ID
- sonographic cervical length
- Conditions
- Cervical Dystocia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Posted 7 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison between Sonographic Cervical Length and Bishop Score in Preinduction Cervical Assessment prior to induction of labor as regards induction success.
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:
- Personal history: including name, age, occupation, residence and special habits of medical importance.
- Obstetric history: including gestational age and regular antenatal care.
- Past history: including any medical disorder e.g Diabetes mellitus, hypertension or any surgical procedure.
- History of present pregnancy: duration of pregnancy from last menstrual period, any complications occurred or any medication used during pregnancy.
- Examination of the participants:
- General examination: level of consciousness, vital data, complexion.
- Abdominal examination: fundal level, lie of the fetus, detection of any uterine contractions and fetal heart rate.
- 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:
- Patient will be asked to void.
- Vaginal probe will be inserted using direct visualization.
- Identification of bladder and fetal presenting part.
- Identification of abnormal findings as placenta previa or absence of fetal heart motion.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction of labor | – | Other: Bishop score, Other: cervical length200 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. |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (8 listed)
- Nulliparous patients.
- Singleton pregnancy.
- Living fetus with cephalic presentation.
- Absence of labor pain.
- Gestational age 37-42 weeks.
Key exclusion criteria (8 listed)
- Non-vertex presentation.
- Previous uterine surgery.
- Multiple pregnancy.
- Fetal or maternal complications that might cause cesarean section.
- Liquor abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bishop scorecalculation of modified Bishop score in numbers by digital vaginal examination | Other | Induction of labor |
| cervical lengthmeasuring cervical length by trans-vaginal ultrasound | Other | Induction of labor |
Primary outcome
Cervical Length Prior to Labor Induction
Time frame: 24 hours
median cervical length measured by transvaginal ultrasound in centimetres
Bishop Score Prior to Induction of Labor
Time frame: 72 hours
median Bishop score assessed by digital vaginal examination as follows: 1. 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. 2. 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. 3. 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. 4. 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. 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. Note that a score more than 10 means patient is in labor not needing induction of labor.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Dystocia, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Length Prior to Labor Induction (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2016.