Accuracy of Different Scoring Systems for Predicting Successful Induction of Labor

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04325256
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Actual Duration (Months): 19.4
• Patients Per Site Per Month: 20.6

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Induction of Labor Affected Fetus / Newborn	Procedure: Manipal ultrasound scoring system; Procedure: Levine scoring system

Study Design

• Study Type: Observational
• Actual Enrollment: 400 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Accuracy of Different Scoring Systems for Predicting Successful Induction of Labor: a Cross-sectional Study
• Actual Study Start Date: Dec 1, 2020
• Actual Primary Completion Date: May 31, 2022
• Actual Study Completion Date: Jul 15, 2022

Arms and Interventions

Arm

Intervention/Treatment

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.

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.; Procedure: 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

Outcome Measures

Primary Outcome Measures

1. The rate of successful induction of labor [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Abbas	Assiut	Cairo	Egypt	002

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Mohamed Abbas, Principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04325256
• Other Study ID Numbers: IOLSC
• First Posted: Mar 27, 2020
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 25, 2022