CompletedPhase 2ACTRN12611000420943

Randomized Clinical Trial between Titrated oral dose of Misoprostol and Propess for Induction of Labor


Sponsor

King Abdulaziz University

Enrollment

150 participants

Start Date

Jan 1, 2011

Study Type

Interventional

Conditions

Summary

The main objective of the proposed research project is to determine the best protocol to induce labor. A randomized clinical trial will be done to compare two protocols of titrated oral misoprostol and vaginal dinoprostone. This study will have major clinical impact on a very important and frequent clinical situation. This study will have major clinical impact on a very important and frequent clinical situation. Testing the efficacy of titrated oral Misoprostol to achieve induction of labor with lower side effects by giving Misoprostol in lower doses and increased frequency.


Eligibility

Sex: Females

Plain Language Summary

Simplified for easier understanding

This trial compares two methods of inducing labour: low-dose oral misoprostol tablets versus a slow-release vaginal insert (Propess). It is for women with a singleton pregnancy who need labour induction and have an unfavourable cervix (Bishop score below 6), and who have not had a previous caesarean section.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

20 mcg (20 ml) of the solution of misoprostol, as prescribed by the physician, is given to the patient orally every hour for 2 hours. If no uterine activity is present, increase the misoprostol dose b

20 mcg (20 ml) of the solution of misoprostol, as prescribed by the physician, is given to the patient orally every hour for 2 hours. If no uterine activity is present, increase the misoprostol dose by 10 mcg (10 ml) i.e. 30 mcg (30) and continue this dose every hour for 3 hours. Active labor is defined as regular uterine contractions occurring every 3-5 minutes and lasting 60 seconds or more. If the patient is not in active labor, 2 hours of observation without any dose was given. If still not in labor, increase the dose by 10 mcg (10 ml) i.e. 40 mcg (40 ml) for one hour. This is followed by 2 hours of observation. If still not in active labor the dose is increased by 10 mcg (10 ml) i.e. 50 mcg (50 ml) for one hour and finally increased by 10 mcg (10 ml) i.e. 60 mcg (60 ml) hourly for four hours, oxytocin should be started as per hospital's protocol. Oxytocin should be started no sooner than 2 hours after the last misoprostol dose. Once active labor is established, misoprostol is stopped.


Locations(1)

Saudi Arabia

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