Induction Of Labor: Predictors of Outcomes

Induction of Labor Affected Fetus / Newborn Clinical Trial

— IOL-ID  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04350437
• Other study ID #: IOL-ID
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: April 2020
• Source: Assiut University
• Contact: Sherif A shazly, M.S
• Phone: +15075131392
• Email: sherif.shazly.mogge[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: July 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn

Intervention

Drug:
• induction of labor
Giving drugs to facilitate uterine contractions and fasten the process of delivery

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Assiut University	Aswan University, Middle East OBGYN graduate education Foundation

References & Publications (4)

Grobman WA, Bailit J, Lai Y, Reddy UM, Wapner RJ, Varner MW, Thorp JM Jr, Leveno KJ, Caritis SN, Prasad M, Tita ATN, Saade G, Sorokin Y, Rouse DJ, Blackwell SC, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development Mat — View Citation

Khandelwal R, Patel P, Pitre D, Sheth T, Maitra N. Comparison of Cervical Length Measured by Transvaginal Ultrasonography and Bishop Score in Predicting Response to Labor Induction. J Obstet Gynaecol India. 2018 Feb;68(1):51-57. doi: 10.1007/s13224-017-10 — View Citation

Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Mathews TJ. Births: final data for 2011. Natl Vital Stat Rep. 2013 Jun 28;62(1):1-69, 72. — View Citation

Teixeira C, Lunet N, Rodrigues T, Barros H. The Bishop Score as a determinant of labour induction success: a systematic review and meta-analysis. Arch Gynecol Obstet. 2012 Sep;286(3):739-53. doi: 10.1007/s00404-012-2341-3. Epub 2012 May 1. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cesarean section rate	Incidence and indication of Cesarean section following induction of labor	Within 24 hours from start of induction of labor
Secondary	Suspected intraamniotic infection	Maternal pyrexia > 39 or > 38 on 2 occasions	From start of induction of labor to 24 hours after delivery
Secondary	Postpartum hemorrhage	Blood loss > 1000 ml after delivery	From start of induction of labor to 24 hours after delivery
Secondary	Low neonatal APGAR Score	APGAR score < 7 at 5 minutes postpartum	5 minutes after delivery
Secondary	Admission to neonatal intensive care unit	Admission of the newborn to intensive care unit and its indication	Within 1 hour of delivery

External Links

•   official website for the NGO foundation that the principle investigator created and sponsor the research