Induction of Labor Affected Fetus / NewbornNCT03175406
Predicting the Outcomes of Labor Induction
An observational study of Induction of Labor Affected Fetus / Newborn, run by Ain Shams University.
Trial summary
Pre induction assessment using bishop scoring system and Manipal cervical scoring system performed on 105 pregnant females Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Manipal cervical scoring system
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 1 Apr 2017
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: 105 females with singleton term pregnancy undergoing induction of labor
Who may be able to join
- Singleton gestation at 37 completed weeks or greater .
- Cephalic presentation.
- Longitudinal lie.
- Living fetus.
- Intact membrane
Who cannot join
- Previous cesarean delivery or rupture uterus.
- Antepartum hemorrhage including (abruptio placenta, placenta previa or vasa previa).
- Abnormal fetal lie or presentation.
- Pervious uterine surgery as myomectomy.
- Category II, III non stress test.
- Pelvic structural deformity.
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- Intrautrine growth retardation or macrosomia (estimated fetal weight ˃ than 4kg).
- Patients who received any pre induction ripening.
- Active genital herpes.
- Invasive cervical carcinoma
About this study
Official title: Comparing the Accuracy of Manipal Cervical Scoring System and Modified Bishop Score in Predicting Successful Induction of Labor
Pre induction assessment using bishop scoring system and Manipal cervical scoring system performed on 105 pregnant females
Read the detailed description
preinduction cervical assessment using The Burnett modification of Bishop score with
- Cervical dilatation in centimeters will be given a score of zero if dilatation less than 1cm, a score of 1 if 1-2 cm dilated, a score of 2 if more than 2 cm dilataion.
- Length of the cervix will be given a score of zero if more than 2 cm, a score of 1 if 1-2 cm, a score of 2 if less than 1 cm.
- Station of fetal head will be given a score of zero if -2 or higher , a score of 1 if -1, a score of 2 if zero or lower.
- Consistency of the cervix will be given a score of zero if firm, a score of 1 if soft and a score of 2 if soft and stretchable.
- 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. and also preinduction cervical assessment using transvaginal ultrasound and Manipal system where:
- Length of the cervix will be given a score of zero if more than 3 cm, a score of 1 if 2-3 cm, a score of 2 if less than 2 cm.
- Length of the funnel will be given a score of zero if absent, a score of 1 if ≤ 0.5 cm, a score of 2 if more than 0.5 cm.
- width of the funnel will be given a score of zero if absent, a score of 1 if ≤ 0.5 cm, a score of 2 if more than 0.5 cm.
- cervical position and shape will be given a score of zero if curved, a score of 2 if straight
- Distance of presenting part to external os will be given a score of zero if more than 3 cm, a score of 1 if 2-3 cm, a score of 2 if less than 2 cm
- Being tested
- Manipal cervical scoring system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manipal cervical scoring systemDiagnostic test
Also called The Burnett modification of Bishop score
What is being measured
The primary outcome is the main question the study is designed to answer.
the occurrence of active labor
successful labor induction(IOL)
Measured: within one day of labor induction
Secondary outcomes (4)
The interval from onset of induction to active labor
duration of induction
Measured: 24 hours
Successful vaginal delivery
Measured: 48 hours
The need for cesarean delivery (CS)
indication of CS (fetal distress ,failed induction,...)
Measured: 24 hours
maternal and fetal complication associated with IOL
tachy systole, postpartum hemorrhage, fetal distress
Measured: during induction ,labor, and 24 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Apr 2016
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of Labor Affected Fetus / NewbornStudies 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Rasheedy Ali, Ain Shams University
- Investigators
- Gasser M El-Bishry, MD,FRCOG, Study chair, ProfessorIhab F Allam, MD, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175406
- Sponsor's protocol ID
- ASU maternity hospital
- Status last verified
- May 2017
- First submitted
- 28 May 2017
- Last updated
- 5 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Accuracy of Manipal Cervical Scoring System and Modified Bishop Score in Predicting Successful Induction of Labor
- ClinicalTrials.gov ID
- NCT03175406
- Acronym / sponsor ID
- ASU maternity hospital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 5 Jun 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.
Pre induction assessment using bishop scoring system and Manipal cervical scoring system performed on 105 pregnant females
Detailed description
preinduction cervical assessment using The Burnett modification of Bishop score with
- Cervical dilatation in centimeters will be given a score of zero if dilatation less than 1cm, a score of 1 if 1-2 cm dilated, a score of 2 if more than 2 cm dilataion.
- Length of the cervix will be given a score of zero if more than 2 cm, a score of 1 if 1-2 cm, a score of 2 if less than 1 cm.
- Station of fetal head will be given a score of zero if -2 or higher , a score of 1 if -1, a score of 2 if zero or lower.
- Consistency of the cervix will be given a score of zero if firm, a score of 1 if soft and a score of 2 if soft and stretchable.
- 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. and also preinduction cervical assessment using transvaginal ultrasound and Manipal system where:
- Length of the cervix will be given a score of zero if more than 3 cm, a score of 1 if 2-3 cm, a score of 2 if less than 2 cm.
- Length of the funnel will be given a score of zero if absent, a score of 1 if ≤ 0.5 cm, a score of 2 if more than 0.5 cm.
- width of the funnel will be given a score of zero if absent, a score of 1 if ≤ 0.5 cm, a score of 2 if more than 0.5 cm.
- cervical position and shape will be given a score of zero if curved, a score of 2 if straight
- Distance of presenting part to external os will be given a score of zero if more than 3 cm, a score of 1 if 2-3 cm, a score of 2 if less than 2 cm
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 105 females with singleton term pregnancy undergoing induction of labor
Key inclusion criteria (5 listed)
- Singleton gestation at 37 completed weeks or greater .
- Cephalic presentation.
- Longitudinal lie.
- Living fetus.
- Intact membrane
Key exclusion criteria (10 listed)
- Previous cesarean delivery or rupture uterus.
- Antepartum hemorrhage including (abruptio placenta, placenta previa or vasa previa).
- Abnormal fetal lie or presentation.
- Pervious uterine surgery as myomectomy.
- Category II, III non stress test.
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 |
|---|---|---|
| Manipal cervical scoring systemAlso: The Burnett modification of Bishop score | Diagnostic test | – |
Primary outcome
the occurrence of active labor
Time frame: within one day of labor induction
successful labor induction(IOL)
4 secondary outcomes
The interval from onset of induction to active labor
Time frame: 24 hours
Successful vaginal delivery
Time frame: 48 hours
The need for cesarean delivery (CS)
Time frame: 24 hours
maternal and fetal complication associated with IOL
Time frame: during induction ,labor, and 24 hours postpartum
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 5 Jun 2017.
- 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.
Gasser M El-Bishry, MD,FRCOG study chair
Professor
Ihab F Allam, MD study director
Professor
Questions about this trial
What is this clinical trial studying?
An observational study of Induction of Labor Affected Fetus / Newborn, run by Ain Shams University.
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 10 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 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
the occurrence of active labor (time frame: within one day of labor induction). 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 5 Jun 2017.