Failure of Vaginal Delivery After Induction

Labor Pain Clinical Trial

Official title:

Comparison of Maternal Outcome Between Patients Undergoing Induction of Labor With Oral Misoprostol Alone and Oral Misoprostol and Foley's Catheter Both at a Tertiary Care Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02758340
• Other study ID #: KarachiDMC
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2016
• Last updated: November 28, 2016
• Start date: April 2016
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Karachi Medical and Dental College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The study will compare the number of women who deliver vaginally after artificial initiation of labor pains(i.e. induction of labor) by two methods. Half of the women would receive tablet misoprostol vaginally and the other half would receive tablet misoprostol and foley's balloon catheter both.

Description:

Artificial initiation of labor pains has become a common occurrence. A variety of methods are employed to initiate labor pains. Labor pains are more successful in culminating into vaginal delivery if the neck of womb that is the cervix is soft (ripe). This is usually achieved by ripening agents. They include drugs and devices that help soften the cervix. Misoprostol and foley's balloon catheter both are used to soften the cervix so that vaginal delivery is possible. Both work on different aspects of the softening of cervix.

Misoprostol acts on shortening the cervix and making it more pliable Foley's balloon helps to open up the cervix that is it aids in dilating the cervical canal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Gestational age > 37 weeks assessed by Last Menstrual Period and dating scan.

• Women with singleton pregnancy assessed by ultrasound.

• Fetus in vertex presentation assessed by ultrasound.

• Age 20-40 years.

• Bishop score <4.

Exclusion Criteria:

• Non-consenting.

• Gestational age < 37 weeks.

• Patients with history of placenta previa.

• Patients with history of placental abruption.

• Ruptured membranes.

• Patients with history of vaginal infection.

• Patients with history of congenital anomalies in previous deliveries.

• Patients with history of stroke, renal impairment and chronic obstructive pulmonary disease, chronic liver disease and congestive cardiac failure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Misoprostol
Women would be given misoprostol tablet by mouth

Device:
• foley's balloon catheter
foley's balloon catheter would be inserted through vagina into cervix.

Locations

Country	Name	City	State
Pakistan	Abbasi shaheed hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Karachi Medical and Dental College

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	failure of vaginal delivery i.e.percentage of women in both groups who would fail to deliver vaginally after 24 hours of induction.		six months	No