Failure of Vaginal Delivery After Induction
This trial is active, not recruiting.
|Treatments||misoprostol, foley's balloon catheter|
|Sponsor||Karachi Medical and Dental College|
|Start date||April 2016|
|End date||November 2016|
|Trial size||310 participants|
|Trial identifier||NCT02758340, KarachiDMC|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver)|
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
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
|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.|
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