Predicting the Outcomes of Labor Induction

NCT ID: NCT03175406

Last Updated: 2017-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-01

Study Completion Date

2017-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Pre induction assessment using bishop scoring system and Manipal cervical scoring system performed on 105 pregnant females

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

preinduction cervical assessment using The Burnett modification of Bishop score with

1. 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.
2. 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.
3. 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.
4. 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.
5. 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:

1. 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.
2. 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.
3. 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.
4. cervical position and shape will be given a score of zero if curved, a score of 2 if straight
5. 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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Induction of Labor Affected Fetus / Newborn

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Manipal cervical scoring system

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

The Burnett modification of Bishop score

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Singleton gestation at 37 completed weeks or greater .
2. Cephalic presentation.
3. Longitudinal lie.
4. Living fetus.
5. Intact membrane

Exclusion Criteria

1. Previous cesarean delivery or rupture uterus.
2. Antepartum hemorrhage including (abruptio placenta, placenta previa or vasa previa).
3. Abnormal fetal lie or presentation.
4. Pervious uterine surgery as myomectomy.
5. Category II, III non stress test.
6. Pelvic structural deformity.
7. Intrautrine growth retardation or macrosomia (estimated fetal weight ˃ than 4kg).
8. Patients who received any pre induction ripening.
9. Active genital herpes.
10. Invasive cervical carcinoma
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Radwa Rasheedy Ali

lecturer of obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gasser M El-Bishry, MD,FRCOG

Role: STUDY_CHAIR

Professor

Ihab F Allam, MD

Role: STUDY_DIRECTOR

Professor

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ASU maternity hospital

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Detection of Preterm Labour by Cervical Length
NCT04104984 UNKNOWN EARLY_PHASE1
Outpatient Foley Cervix Priming
NCT02842879 COMPLETED NA