Failed InductionNCT03430804
Transvaginal Sonographic Measurement of Cervical Length Versus Bishop Score in Induction of Labour for Prediction of Caesarean Delivery.
An observational study of Failed Induction and Cervical Dystocia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Transvaginal sonographic measurement of cervical length versus Bishop score in labour induction at term for prediction of Caesarean delivery. This study is prospective study. This study will be carried out in Ain-shams maternity hospital. Sample size of 320 parturients. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Failed Induction, Cervical Dystocia
- What is being tested?
- Bishop score calculation of modified Bishop score in numbers by digital vaginal examination
- How many people
- 320 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Aug 2017to 12 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Single group 320 parturients udergoing induction of labour at term
Who may be able to join
- 1. Age (18-35) years. 2. Singleton pregnancy. 3. (37-42) weeks gestation. 4. Living fetus. 5. Cephalic presentation. 6. Absence of active labour. 7. No contraindication to vaginal delivery. 8. Average amount of clear liquor. 9. No history of uterine scar (myomectomy or previous C.S(.
Who cannot join
- 1. Malpresentation. 2. Major fetal congenital anomalies as hydrocephalous \& dead fetus. 3. Patient received any pre induction ripping methods for example: (Acetic Acid-Prostaglandins).
- 4. Any medical history contraindicating vaginal delivery. 5. Assessment meconium staining to liquor or any evidence of chorioamnionitis. 6. Previous uterine surgery. 7. Multiple gestations. 8. Women with allergy to prostaglandins.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transvaginal Sonographic Measurement of Cervical Length Versus Bishop Score in Induction of Labour at Term for Prediction of Caesarean Delivery
Transvaginal sonographic measurement of cervical length versus Bishop score in labour induction at term for prediction of Caesarean delivery. This study is prospective study. This study will be carried out in Ain-shams maternity hospital. Sample size of 320 parturients.
Read the detailed description
Patients and Methods
Study design:
This study is prospective study, comparative clinical trial for a test against a gold standard with blinding of the evaluator
Study setting:
This study will be carried out in Ain-Shams university maternity hospital.
Methods:
- All patients recruited were given an oral consent.
- All patients were subjected to the following:
History of the patient:
- Detailed and careful history was taken from the patient as the following:
- Personal history: name, age, occupation, residence and special habit of medical importance.
- Obstetric history: including last menstrual period, Gestation 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 patient: <!-- -->
- General examination: as regard level of consciousness, vital data, and complexion.
- Abdominal examination: as regard fundal level, lie of the fetus, detection of any uterine contractions and fetal heart rate.
- Pelvic Examination: as regard pelvic capacity, presenting part, presence of rupture of membranes and cervical assessment as regard cervical dilation, station and presenting part.
- Investigations. Complete blood count , Rh, transvaginal ultra sound and non-stress test.
- All patients had vaginal examination for assessing the (Bishop Score,1964) before induction of labour.
- All women had transvaginal ultrasound for assessment of cervical length using (median digital GAIA) Ultrasonic machine.
Protocol of transvaginal ultrasound will be done as follow:
- Patient will be asked to void.
- Vaginal probe will be inserted using direct visualization with K-Y gel.
- Identification of bladder, amniotic fluid and fetal presenting part.
- Identification of abnormal findings as placenta pervia or absence of fetal heart motion.
- Identification of midline sagittal plane of the cervix and looking in the proximal one third of the image for the internal 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 by placing the calipers appropriately and recording the distance between internal and external cervical os.
- Transvaginal ultrasound will be done to assess cervical length using medison sonoace 8800 (median digital GAIA) ultrasound machine equipped with a 7.5 m hertz by vaginal probe in Ain-Shams University Maternity Hospital.
- Induction of labour will be done using intravaginal misoprostol (25 microgram) then digital examination will be made 6 h after the first intravaginal administration; if necessary, 3 doses were given at 6 hours interval. External Cardiotocography will be regularly performed to monitor the condition of the fetus.
- Continuous Cardiotocography will be used in all cases. If necessary, amniotomy will be performed. Intravenous oxytocin administration will be started when there is an arrest of dilatation, starting at 1milli-international unit/minute and increasing 1 mIU every 30 min as necessary. For analgesia, intramuscular pethidine will be offered.
- Caesarean delivery will be done due to pathological fetal heart rate trace, arrest the fetal head for at least one hour despite adequate uterine contractions.
- Conditions
- Failed Induction, Cervical Dystocia
- Being tested
- Bishop score calculation of modified Bishop score in numbers by digital vaginal examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bishop score calculation of modified Bishop score in numbers by digital vaginal examinationOther
Also called cervical length measuring cervical length by trans-vaginal ultrasound
Measurement of cervical length by transvaginal ultrasound and digital examination of Bishop score in 320 parturients undergoing labour induction at term
| Study group | Role | What they receive |
|---|---|---|
| Single gruop320 parturients | Measurement of cervical length and digital examination of Bishop score in 320 women undergoing induction of labour will be carried out in ain shams university maternity hospital. Receives: Other: Bishop score calculation of modified Bishop score in numbers by digital vaginal examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical length
median cervical length measured by transvaginal ultrasound in centimetres.
Measured: 24 hours
Bishop score
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 dilatation.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start14 Aug 2017
- Primary completion14 Dec 2017
- Study completion12 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed InductionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Adel Mazroa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430804
- Sponsor's protocol ID
- Asu-August 2017
- Status last verified
- Feb 2018
- First submitted
- 31 Jan 2018
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Sonographic Measurement of Cervical Length Versus Bishop Score in Induction of Labour at Term for Prediction of Caesarean Delivery
- ClinicalTrials.gov ID
- NCT03430804
- Acronym / sponsor ID
- Asu-August 2017
- Conditions
- Failed Induction, Cervical Dystocia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 14 Dec 2017 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transvaginal sonographic measurement of cervical length versus Bishop score in labour induction at term for prediction of Caesarean delivery. This study is prospective study. This study will be carried out in Ain-shams maternity hospital. Sample size of 320 parturients.
Detailed description
Patients and Methods
Study design:
This study is prospective study, comparative clinical trial for a test against a gold standard with blinding of the evaluator
Study setting:
This study will be carried out in Ain-Shams university maternity hospital.
Methods:
- All patients recruited were given an oral consent.
- All patients were subjected to the following:
History of the patient:
- Detailed and careful history was taken from the patient as the following:
- Personal history: name, age, occupation, residence and special habit of medical importance.
- Obstetric history: including last menstrual period, Gestation 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 patient: <!-- -->
- General examination: as regard level of consciousness, vital data, and complexion.
- Abdominal examination: as regard fundal level, lie of the fetus, detection of any uterine contractions and fetal heart rate.
- Pelvic Examination: as regard pelvic capacity, presenting part, presence of rupture of membranes and cervical assessment as regard cervical dilation, station and presenting part.
- Investigations. Complete blood count , Rh, transvaginal ultra sound and non-stress test.
- All patients had vaginal examination for assessing the (Bishop Score,1964) before induction of labour.
- All women had transvaginal ultrasound for assessment of cervical length using (median digital GAIA) Ultrasonic machine.
Protocol of transvaginal ultrasound will be done as follow:
- Patient will be asked to void.
- Vaginal probe will be inserted using direct visualization with K-Y gel.
- Identification of bladder, amniotic fluid and fetal presenting part.
- Identification of abnormal findings as placenta pervia or absence of fetal heart motion.
- Identification of midline sagittal plane of the cervix and looking in the proximal one third of the image for the internal 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 by placing the calipers appropriately and recording the distance between internal and external cervical os.
- Transvaginal ultrasound will be done to assess cervical length using medison sonoace 8800 (median digital GAIA) ultrasound machine equipped with a 7.5 m hertz by vaginal probe in Ain-Shams University Maternity Hospital.
- Induction of labour will be done using intravaginal misoprostol (25 microgram) then digital examination will be made 6 h after the first intravaginal administration; if necessary, 3 doses were given at 6 hours interval. External Cardiotocography will be regularly performed to monitor the condition of the fetus.
- Continuous Cardiotocography will be used in all cases. If necessary, amniotomy will be performed. Intravenous oxytocin administration will be started when there is an arrest of dilatation, starting at 1milli-international unit/minute and increasing 1 mIU every 30 min as necessary. For analgesia, intramuscular pethidine will be offered.
- Caesarean delivery will be done due to pathological fetal heart rate trace, arrest the fetal head for at least one hour despite adequate uterine contractions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single gruop320 parturients | – | Other: Bishop score calculation of modified Bishop score in numbers by digital vaginal examinationMeasurement of cervical length and digital examination of Bishop score in 320 women undergoing induction of labour will be carried out in ain shams university maternity hospital. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Single group 320 parturients udergoing induction of labour at term
Key inclusion criteria (1 listed)
- 1. Age (18-35) years. 2. Singleton pregnancy. 3. (37-42) weeks gestation. 4. Living fetus. 5. Cephalic presentation. 6. Absence of active labour. 7. No contraindication to vaginal delivery. 8. Average amount of clear liquor. 9. No history of uterine scar (myomectomy or previous C.S(.
Key exclusion criteria (2 listed)
- 1. Malpresentation. 2. Major fetal congenital anomalies as hydrocephalous \& dead fetus. 3. Patient received any pre induction ripping methods for example: (Acetic Acid-Prostaglandins).
- 4. Any medical history contraindicating vaginal delivery. 5. Assessment meconium staining to liquor or any evidence of chorioamnionitis. 6. Previous uterine surgery. 7. Multiple gestations. 8. Women with allergy to prostaglandins.
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 score calculation of modified Bishop score in numbers by digital vaginal examinationAlso: cervical length measuring cervical length by trans-vaginal ultrasoundMeasurement of cervical length by transvaginal ultrasound and digital examination of Bishop score in 320 parturients undergoing labour induction at term | Other | Single gruop320 parturients |
Primary outcome
Cervical length
Time frame: 24 hours
median cervical length measured by transvaginal ultrasound in centimetres.
Bishop score
Time frame: 72
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 dilatation. 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
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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 Failed Induction and Cervical Dystocia, run by Ain Shams University 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 1 inclusion and 2 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 14 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (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 14 Feb 2018.