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Completed

NCT Number: NCT02758340

Failure of Vaginal Delivery After Induction

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.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Abbasi shaheed hospital

Karachi, Sindh, 74700, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

Women would be given misoprostol tablet by mouth

Other names: cytotec

foley's balloon catheter

Device

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

Other names: foley's catheter

Primary outcomes

  1. 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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Karachi Medical and Dental College

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 2, 2016
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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