An observational study in Failed Induction and Cervical Dystocia, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-14.
Sponsored by Ain Shams University · Observational
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.
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:
History of the patient:
Detailed and careful history was taken from the patient as the following:
History of present pregnancy: duration of pregnancy from last menstrual period, any complications occurred or any medication used during pregnancy.
Examination of the patient:
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Protocol of transvaginal ultrasound will be done as follow:
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.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's enrollment of 320 is above the median of 212 across 12 observational studies indexed under Dystocia.
Browse Dystocia studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Single group 320 parturients udergoing induction of labour at term
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Malpresentation. 2. Major fetal congenital anomalies as hydrocephalous \& dead fetus. 3. Patient received any pre induction ripping methods for example: (Acetic Acid-Prostaglandins).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Bishop score calculation of modified Bishop score in numbers by digital vaginal examination
Measurement of cervical length by transvaginal ultrasound and digital examination of Bishop score in 320 parturients undergoing labour induction at term
Also known as: cervical length measuring cervical length by trans-vaginal ultrasound
Cervical length
median cervical length measured by transvaginal ultrasound in centimetres.
Time frame: 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.
Time frame: 72
Ran from Aug 2017 to primary completion in Dec 2017, 4 months.
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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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