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Induction Of Labor: Predictors of Outcomes

Outcomes of Induction of Labor: a Prospective Multi-center Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04350437
Acronym
IOL-ID
Enrollment
3000
Registered
2020-04-17
Start date
2020-07-01
Completion date
2021-07-30
Last updated
2020-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Labor Affected Fetus / Newborn

Keywords

labor induction, assessment score

Brief summary

Induction of labor is a widely used intervention in OBGYN practice. Doctors still use the old Bishop score in patients' follow up. It remains difficult to anticipate the outcomes and the possibility of adverse effects during this process. In this large prospective multicentric interventional study, we aim to develop a more precise and sensitive score based on machine learning tools programmed on python 3.8 This new tool will account for many variables in patient demography(age, race, weight ... etc ) and medical history (previous OBGYN surgery, comorbidities .... etc). These variables not usually found in the classic bishop score. We predict that our analysis will aid doctors in making better decisions and efficiently predict the outcomes, need for switching to operative delivery and possible complications. Machine learning and digital calculation of hazards will allow more precise assessment and more efficient management during IOL as it considers variables not included in clinical scores. this study aims to provide modern and efficient assessment parameters to guide clinical decision making during the IOL process and help doctors predict its outcomes based on subtle factors not usually considered. This will minimize the complications and allow more evidence-based practice.

Detailed description

the objective is to create a database registry documenting the induction of labor (IOL) process and apply machine learning tools to create a more precise assessment score for doctors as a contemporary follow-up method. we will collect data from at least 12 centers worldwide describing the course, outcomes, maternal or fetal complications, and any related data. The data will be collected after ethical approval and from consenting patients in a prospective manner. during the period from July 1st, 2020 to June 30th, 2021 (anticipated dates). each center will be responsible for quality assessment, data collection, and ensuring the data is accurate, complete, and representative. Data collection includes baseline pelvic examination (cervical position, consistency, dilation, effacement, fetal position, and bishop score), method of induction and their time of administration in relation to index time (start of IOL), findings and time of serial pelvic examinations, fetal heart tone, and maternal vital signs. The entry of data from serial examinations will continue during active labor and fetal and maternal outcomes will be reported. If the diagnosis of failed IOL is made and obstetric team decides delivery by Cesarean section, criteria of diagnosis/indication of Cesarean delivery will be reported. Length of active labor and the second stage will be documented, and maternal/perinatal complications will be reported. the collectors must ensure patient confidentiality and safety. Inclusion criteria:- * Pregnant women admitted for IOL, aged between 18 to 40 years * Term or late preterm pregnancy (gestational age at 34 weeks or beyond) * A reassuring fetal heart tracing prior to IOL Exclusion criteria:- * Fetal growth restriction with abnormal Doppler indices * Intrauterine fetal death * Suspected intra-amniotic infection prior to IOL * Fetal major congenital anomalies * Patients who decline IOL in prior or during IOL without medical indication statistical analysis :- Data will be described using (mean, median, standard deviation, range) in the final sample. Machine learning method is superior to traditional statistical methods as it provides robust and automatic estimation of complex relationships between different variables and clinical outcomes. Data will be utilized as xi and yi where xi presents input (features) and yi presents dependent variables (outcomes). Functional regression is based on support vector machine by regressing the outcomes yi on inputs xi. Model Validation will be performed via bootstrap estimation to evaluate the predictive ability of the functional regression models. Data will be split to training data (approximately 63% of the data) to create prediction model where bootstrapping will be applied, and testing data where prediction model will be validated. Machine learning models will be created using python 3.8.

Interventions

DRUGinduction of labor

Giving drugs to facilitate uterine contractions and fasten the process of delivery

Sponsors

Aswan University
CollaboratorOTHER
Middle-East OBGYN Graduate Education Foundation
CollaboratorOTHER
Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Detailed data from patients undergoing induction of labor. Analysis of the data will predict the outcomes in regards to possible complications.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Pregnant women admitted for IOL, aged between 18 to 40 years * Term or late preterm pregnancy (gestational age at 34 weeks or beyond) * Reassuring fetal heart tracing prior to IOL

Exclusion criteria

* Fetal growth restriction with abnormal Doppler indices * Intrauterine fetal death * Suspected intra-amniotic infection prior to IOL * Fetal major congenital anomalies * Patients who decline IOL in priori or during IOL without medical indication

Design outcomes

Primary

MeasureTime frameDescription
Cesarean section rateWithin 24 hours from start of induction of laborIncidence and indication of Cesarean section following induction of labor

Secondary

MeasureTime frameDescription
Suspected intraamniotic infectionFrom start of induction of labor to 24 hours after deliveryMaternal pyrexia \> 39 or \> 38 on 2 occasions
Postpartum hemorrhageFrom start of induction of labor to 24 hours after deliveryBlood loss \> 1000 ml after delivery
Low neonatal APGAR Score5 minutes after deliveryAPGAR score \< 7 at 5 minutes postpartum
Admission to neonatal intensive care unitWithin 1 hour of deliveryAdmission of the newborn to intensive care unit and its indication

Contacts

Primary ContactSherif A shazly, M.S
sherif.shazly.mogge@gmail.com+15075131392
Backup Contactislam A Ahmed, M.B.B.Ch
islam.ali.mogge@gmail.com01062207716

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026