Induction of Labor Affected Fetus / NewbornNCT04325256
Accuracy of Different Scoring Systems for Predicting Successful Induction of Labor
An observational study of Induction of Labor Affected Fetus / Newborn, run by Assiut University at 1 site in Egypt.
Trial summary
Induction of labour (IOL) nowadays is a common procedure in obstetric practice. Presently, IOL is done for 20% of pregnancies for various maternal and fetal indications and nearly 20% of labour inductions end up in caesarean deliveries. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Manipal ultrasound scoring system and Levine scoring system
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 15 Jul 2022
- 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 Any age
- Women only
- Child, Adult, Older adult
Study population: pregnant women who will attend the labor unit for induction
Who may be able to join
- Singleton pregnancy.
- Pregnant ≥ 37 weeks gestation.
- Fetus with longitudinal lie and vertex presentation.
- Intact membranes.
- No vaginal bleeding.
Who cannot join
- Patients with previous cesarean delivery.
- Previous uterine surgery.
- Antepartum hemorrhage.
- Cephalopelvic disproportion.
- Category II or III non-stress test.
- Malpresentation.
Show all 9Show fewer
- Intrauterine fetal death.
- Fetal growth restriction.
- Fetuses with major congenital malformations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Different Scoring Systems for Predicting Successful Induction of Labor: a Cross-sectional Study
Induction of labour (IOL) nowadays is a common procedure in obstetric practice. Presently, IOL is done for 20% of pregnancies for various maternal and fetal indications and nearly 20% of labour inductions end up in caesarean deliveries. The success of IOL mainly depends upon "favourability" of the cervix which is usually assessed by manual examination and Scored as Bishop Score. However, this method is limited by subjectivity and reproducibility and though done in all the patients prior to IOL, several studies have demonstrated poor correlation between Bishop Score and outcome of IOL
- Being tested
- Manipal ultrasound scoring system, Levine scoring system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manipal ultrasound scoring systemProcedure or surgery
length of the cervix from the internal to external os, presence or absence of funneling and if present width and length of funneling at internal os were measured. Distance between presenting part to external os will be measured and position of the cervix i.e. whether curved or straight will also noted.
Levine scoring systemProcedure or surgery
maternal height, parity, body-mass index (BMI) at delivery and the results of modified Bishop's score in calculation of probability of CS
| Study group | Role | What they receive |
|---|---|---|
| study group | All pregnant women who will attend the labor unit for induction of labour due to different indications during the study period will be invited to participate in the study. Receives: Procedure: Manipal ultrasound scoring system; Procedure: Levine scoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of successful induction of labor
an ability to achieve the active phase of labor corresponding to a cervical dilatation of ≥4 cm within 12 h of initiating oxytocin on the first day of induction
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Dec 2020
- Primary completion31 May 2022
- Study completion15 Jul 2022
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.
- More trials run by Assiut 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325256
- Sponsor's protocol ID
- IOLSC
- Status last verified
- Aug 2022
- First submitted
- 26 Mar 2020
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Different Scoring Systems for Predicting Successful Induction of Labor: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04325256
- Acronym / sponsor ID
- IOLSC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 27 Mar 2020 (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.
Induction of labour (IOL) nowadays is a common procedure in obstetric practice. Presently, IOL is done for 20% of pregnancies for various maternal and fetal indications and nearly 20% of labour inductions end up in caesarean deliveries. The success of IOL mainly depends upon "favourability" of the cervix which is usually assessed by manual examination and Scored as Bishop Score. However, this method is limited by subjectivity and reproducibility and though done in all the patients prior to IOL, several studies have demonstrated poor correlation between Bishop Score and outcome of IOL
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Procedure: Manipal ultrasound scoring system, Procedure: Levine scoring systemAll pregnant women who will attend the labor unit for induction of labour due to different indications during the study period will be invited to participate in the study. |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant women who will attend the labor unit for induction
Key inclusion criteria (5 listed)
- Singleton pregnancy.
- Pregnant ≥ 37 weeks gestation.
- Fetus with longitudinal lie and vertex presentation.
- Intact membranes.
- No vaginal bleeding.
Key exclusion criteria (9 listed)
- Patients with previous cesarean delivery.
- Previous uterine surgery.
- Antepartum hemorrhage.
- Cephalopelvic disproportion.
- Category II or 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 ultrasound scoring systemlength of the cervix from the internal to external os, presence or absence of funneling and if present width and length of funneling at internal os were measured. Distance between presenting part to external os will be measured and position of the cervix i.e. whether curved or straight will also noted. | Procedure or surgery | study group |
| Levine scoring systemmaternal height, parity, body-mass index (BMI) at delivery and the results of modified Bishop's score in calculation of probability of CS | Procedure or surgery | study group |
Primary outcome
The rate of successful induction of labor
Time frame: 24 hours
an ability to achieve the active phase of labor corresponding to a cervical dilatation of ≥4 cm within 12 h of initiating oxytocin on the first day of induction
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 25 Aug 2022.
Related trials for Induction of Labor Affected Fetus / Newborn
Active, not recruitingPhase 4
The Stimulation To Induce Mothers Study
Oxytocin, Labor Pain
Recruiting
Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous
Induction of Labor Affected Fetus / Newborn
Recruiting
Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
Induction of Labor Affected Fetus / Newborn
Active, not recruiting
Induction ATAD Catheter and Lower Segment Thickness
Induction of Labor Affected Fetus / Newborn
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Induction of Labor Affected Fetus / Newborn, run by Assiut 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 9 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 25 Aug 2022. 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?
The rate of successful induction of labor (time frame: 24 hours). 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 25 Aug 2022.