Failure of Vaginal Delivery After Induction

November 28, 2016 updated by: samia husain, Karachi Medical and Dental College

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

335

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74700
        • Abbasi Shaheed Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: M=misoprostol
Patients who would receive Only oral misoprostol{(50 micrograms) tab cytotec ¼ tablets (Searle)}. All patients in this group will be given oral misoprostol 50 μg per dose. The dose will be repeated at 4 hours interval up to a maximum of 4 doses till labor is induced (3 contractions per 10 minutes). If labor is not established within 4 hours of the administration of the fourth dose, induction will be considered to be failed
Drug: Misoprostol
Women would be given misoprostol tablet by mouth
Other Names:
  • cytotec
EXPERIMENTAL: M+F=MISOPROSTOL+FOLEY'S BALLOON CATHETER
All patients in this group will be explained the technique of foley's catheter ballooning and informed consent will be taken. The cervix will be visualized with the help of Cusco's speculum. The balloon will be inflated with about 30 cc of sterile water. The catheter will be pulled down to bring the balloon into the cervical canal and will be tapped around the thigh. Patients will also be given oral misoprostol 50 μg per dose. The dose will be repeated at 4 hours interval up to a maximum of 4 doses till labor is induced (3 contractions per 10 minutes).
Drug: Misoprostol
Women would be given misoprostol tablet by mouth
Other Names:
  • cytotec
Device: foley's balloon catheter
foley's balloon catheter would be inserted through vagina into cervix.
Other Names:
  • foley's catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
failure of vaginal delivery i.e.percentage of women in both groups who would fail to deliver vaginally after 24 hours of induction.
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karachi Medical and Dental College

Investigators

  • Principal Investigator: samia husain, MBBS, Karachi Medical and Dental College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (ESTIMATE)

May 2, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

November 29, 2016

Last Update Submitted That Met QC Criteria

November 28, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KarachiDMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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