Induced; BirthNCT03113227
Value of Measuring Cervical Angle and Length by Ultrasound in Prediction of Successful Induction of Delivery
A study testing Transvaginal ultrasound and Vaginal examination in people with Induced; Birth, run by Cairo University at 1 site in Egypt.
Trial summary
Seventy ladies indicated for induction of delivery will be recruited. Two ways of assessment of their cervices will be done before actual induction of labor. First, ultrasound will be done to assess the angle and the length of the cervix. Then vaginal examination will be done to assess the characteristics of cervix. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Induced; Birth
- What is being tested?
- Transvaginal ultrasound and Vaginal examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2017to 9 Jul 2017
- Phase
- Interventional
- 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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- Gestational age between 35 and 42
- Presence of an indication for induction of labour as post-term pregnancy or rupture of membranes
- The fetus is living
- Cephalic presentation
Who cannot join
- Estimated fetal weight more than 4 kilograms
- Malpresentation
- Oligohydramnios
- Polyhydramnios
- Non-reassuring non-stress test before induction of labor
- Cephalo-pelvic disproportion
Show all 11Show fewer
- Previous operation on the cervix as cautery or cerclage
- Previous cesarean section
- Any contraindication to vaginal delivery including placenta previa
- Anomalous fetus
- Morbid obesity
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
Cairo, Greater Cairo, 11956
About this study
Official title: Diagnostic Accuracy of Posterior Cervical Angle and Cervical Length in Prediction of Successful Induction of Labor
Seventy ladies indicated for induction of delivery will be recruited. Two ways of assessment of their cervices will be done before actual induction of labor. First, ultrasound will be done to assess the angle and the length of the cervix. Then vaginal examination will be done to assess the characteristics of cervix. Analysis will be done to identify the best predictor of successful induction of labour.
Read the detailed description
Seventy patients indicated for induction of labor will be recruited. Two ways of assessment of their cervices will be done before actual induction of labor. First, transvaginal ultrasound will be done to assess the posterior angle and the length of the cervix. Then vaginal examination will be done to measure the Bishop score. Analysis will be done to identify the best predictor of successful induction of labour.
- Conditions
- Induced; Birth
- Being tested
- Transvaginal ultrasound, Vaginal examination
- Keywords
- induction of labor, Bishop score, posterior cervical angle, cervical length
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasoundDiagnostic test
Transvaginal ultrasound will be made for assessment of posterior cervical angle and cervical length
Vaginal examinationDiagnostic test
Vaginal examination will be done for assessment of Bishop score
| Study group | Role | What they receive |
|---|---|---|
| Successful Induction of labor group | Active comparator | Both transvaginal ultrasound and vaginal examination will be done for that group Receives: Diagnostic Test: Transvaginal ultrasound; Diagnostic Test: Vaginal examination |
| Failed induction of labor group | Active comparator | Both transvaginal ultrasound and vaginal examination will be done for that group Receives: Diagnostic Test: Transvaginal ultrasound; Diagnostic Test: Vaginal examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of posterior cervical angle
Value of posterior cervical angle will be measured by an investigator
Measured: At around 10 minutes from admission to hospital
Secondary outcomes (2)
Length of the cervix
Length of the cervix will be measured by an investigator
Measured: At around 10 minutes from admission to hospital
Bishop score
Bishop score will be measured by an investigator
Measured: At around 30 minutes from admission to hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start15 Apr 2017
- Primary completion9 Jul 2017
- Study completion9 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Induced; BirthStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Omran, Cairo University
- Investigators
- Eman Omran, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113227
- Sponsor's protocol ID
- 5355
- Status last verified
- Jul 2017
- First submitted
- 10 Apr 2017
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Adwy AM, Sobh SM, Belal DS, Omran EF, Hassan A, Saad AH, Afifi MM, Nada AM. Diagnostic accuracy of posterior cervical angle and cervical length in the prediction of successful induction of labor. Int J Gynaecol Obstet. 2018 Apr;141(1):102-107. doi: 10.1002/ijgo.12425. Epub 2018 Jan 18.
PubMed 29224196
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Posterior Cervical Angle and Cervical Length in Prediction of Successful Induction of Labor
- ClinicalTrials.gov ID
- NCT03113227
- Acronym / sponsor ID
- 5355
- Conditions
- Induced; Birth
- Keywords
- induction of labor, Bishop score, posterior cervical angle, cervical length
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 9 Jul 2017 (actual)
- Study completion
- 9 Jul 2017 (actual)
- First posted
- 13 Apr 2017 (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.
Seventy ladies indicated for induction of delivery will be recruited. Two ways of assessment of their cervices will be done before actual induction of labor. First, ultrasound will be done to assess the angle and the length of the cervix. Then vaginal examination will be done to assess the characteristics of cervix. Analysis will be done to identify the best predictor of successful induction of labour.
Detailed description
Seventy patients indicated for induction of labor will be recruited. Two ways of assessment of their cervices will be done before actual induction of labor. First, transvaginal ultrasound will be done to assess the posterior angle and the length of the cervix. Then vaginal examination will be done to measure the Bishop score. Analysis will be done to identify the best predictor of successful induction of labour.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successful Induction of labor group | Active comparator | Diagnostic Test: Transvaginal ultrasound, Diagnostic Test: Vaginal examinationBoth transvaginal ultrasound and vaginal examination will be done for that group |
| Failed induction of labor group | Active comparator | Diagnostic Test: Transvaginal ultrasound, Diagnostic Test: Vaginal examinationBoth transvaginal ultrasound and vaginal examination will be done for that group |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Singleton pregnancy
- Gestational age between 35 and 42
- Presence of an indication for induction of labour as post-term pregnancy or rupture of membranes
- The fetus is living
- Cephalic presentation
Key exclusion criteria (11 listed)
- Estimated fetal weight more than 4 kilograms
- Malpresentation
- Oligohydramnios
- Polyhydramnios
- Non-reassuring non-stress test before induction of labor
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 |
|---|---|---|
| Transvaginal ultrasoundTransvaginal ultrasound will be made for assessment of posterior cervical angle and cervical length | Diagnostic test | Failed induction of labor group, Successful Induction of labor group |
| Vaginal examinationVaginal examination will be done for assessment of Bishop score | Diagnostic test | Failed induction of labor group, Successful Induction of labor group |
Primary outcome
Value of posterior cervical angle
Time frame: At around 10 minutes from admission to hospital
Value of posterior cervical angle will be measured by an investigator
2 secondary outcomes
Length of the cervix
Time frame: At around 10 minutes from admission to hospital
Bishop score
Time frame: At around 30 minutes from admission to hospital
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 17 Jul 2017.
- Derived from this study: PubMed 29224196Al-Adwy AM, Sobh SM, Belal DS, Omran EF, Hassan A, Saad AH, Afifi MM, Nada AM. Diagnostic accuracy of posterior cervical angle and cervical length in the prediction of successful induction of labor. Int J Gynaecol Obstet. 2018 Apr;141(1):102-107. doi: 10.1002/ijgo.12425. Epub 2018 Jan 18.
- 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.
Eman Omran, M.D. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal ultrasound and Vaginal examination in people with Induced; Birth, run by Cairo 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 5 inclusion and 11 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 17 Jul 2017. 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?
Value of posterior cervical angle (time frame: At around 10 minutes from admission to hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03113227, which also lists 1 linked publication.
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 17 Jul 2017.