Overview

This trial has been completed.

Condition labor pain
Treatments misoprostol, foley's balloon catheter
Phase phase 3
Sponsor Karachi Medical and Dental College
Start date April 2016
End date November 2016
Trial size 335 participants
Trial identifier NCT02758340, KarachiDMC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
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
misoprostol cytotec
Women would be given misoprostol tablet by mouth
(Experimental)
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).
misoprostol cytotec
Women would be given misoprostol tablet by mouth
foley's balloon catheter foley's catheter
foley's balloon catheter would be inserted through vagina into cervix.

Primary Outcomes

Measure
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

Eligibility Criteria

Female participants from 20 years up to 40 years old.

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

Additional Information

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
Principal investigator samia husain, MBBS
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Karachi Medical and Dental College.