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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Mohamed adel mazroa

    Tanta

Other trials in Egypt

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:
  1. Personal history: name, age, occupation, residence and special habit of medical importance.
  2. Obstetric history: including last menstrual period, Gestation 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 patient: <!-- -->
  5. General examination: as regard level of consciousness, vital data, and complexion.
  6. Abdominal examination: as regard fundal level, lie of the fetus, detection of any uterine contractions and fetal heart rate.
  7. 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:

  1. Patient will be asked to void.
  2. Vaginal probe will be inserted using direct visualization with K-Y gel.
  3. Identification of bladder, amniotic fluid and fetal presenting part.
  4. Identification of abnormal findings as placenta pervia or absence of fetal heart motion.
  5. 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.
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 groups in NCT03430804
Study groupRoleWhat they receive
Single gruop320 parturientsMeasurement 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.

  1. Cervical length

    median cervical length measured by transvaginal ultrasound in centimetres.

    Measured: 24 hours

  2. 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.

  1. First posted13 Feb 2018
  2. Study start14 Aug 2017
  3. Primary completion14 Dec 2017
  4. Study completion12 Jan 2018

Resources

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)
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

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.

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