Induction Of Labor: Predictors of Outcomes

NCT04350437 | Unknown

• 1 other identifier: IOL-ID
• Study Type: interventional
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Induction of Labor Affected Fetus / Newborn

Keywords

labor induction; assessment score

Outcome Measures

Primary Outcomes (1)

• Cesarean section rate

  Incidence and indication of Cesarean section following induction of labor

  Within 24 hours from start of induction of labor

Secondary Outcomes (4)

• Suspected intraamniotic infection

  From start of induction of labor to 24 hours after delivery

• Postpartum hemorrhage

  From start of induction of labor to 24 hours after delivery

• Low neonatal APGAR Score

  5 minutes after delivery

• Admission to neonatal intensive care unit

  Within 1 hour of delivery

Study Arms (1)

induction of labor monitoring

OTHER

meticulous data collection from patients and plotting that data in a machine learning model

Drug: induction of labor

Interventions

induction of labor DRUG

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

Also known as: non operative vaginal delivery

induction of labor monitoring

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: only pregnant women ( 36 weeks to 39 weeks of gestation)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead
• Aswan University: collaborator
• Middle-East OBGYN Graduate Education Foundation: collaborator

Related Publications (4)

• 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.

  PMID: 24974591 RESULT

• 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 Maternal-Fetal Medicine Units Network. Defining failed induction of labor. Am J Obstet Gynecol. 2018 Jan;218(1):122.e1-122.e8. doi: 10.1016/j.ajog.2017.11.556. Epub 2017 Nov 11.

  PMID: 29138035 RESULT

• 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.

  PMID: 22546948 RESULT

• 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/s13224-017-1027-y. Epub 2017 Jun 23.

  PMID: 29391676 RESULT

Related Links

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

MeSH Terms

Interventions

Labor, Induced

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Sherif Shazly, M.S

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherif A shazly, M.S

CONTACT

+15075131392; sherif.shazly.mogge@gmail.com

islam A Ahmed, M.B.B.Ch

CONTACT

01062207716; islam.ali.mogge@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer -Assiut University Hospitals - Women Health Hospital

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

Study Record Dates

• First Submitted: April 11, 2020
• First Posted: April 17, 2020
• Study Start: July 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: July 30, 2021
• Last Updated: April 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share