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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04325256
Other study ID # IOLSC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date July 15, 2022

Study information

Verified date August 2022
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date July 15, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: 1. Singleton pregnancy. 2. Pregnant = 37 weeks gestation. 3. Fetus with longitudinal lie and vertex presentation. 4. Intact membranes. 5. No vaginal bleeding. Exclusion Criteria: 1. Patients with previous cesarean delivery. 2. Previous uterine surgery. 3. Antepartum hemorrhage. 4. Cephalopelvic disproportion. 5. Category II or III non-stress test. 6. Malpresentation. 7. Intrauterine fetal death. 8. Fetal growth restriction. 9. Fetuses with major congenital malformations

Study Design


Related Conditions & MeSH terms

  • Induction of Labor Affected Fetus / Newborn

Intervention

Procedure:
Manipal ultrasound scoring system
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 system
maternal height, parity, body-mass index (BMI) at delivery and the results of modified Bishop's score in calculation of probability of CS

Locations

Country Name City State
Egypt Ahmed Abbas Assiut Cairo

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 24 hours
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