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Clinical Trial Summary

The purpose of this study is to estimate the efficacy and safety of the 25mcg vaginal misoprostol for cervical ripening and induction of labour.


Clinical Trial Description

There are many pregnant women require medical intervention to induce labor for some reasons at term. There are two fundamental changes that characterize pre-labor preparation for delivery: sensitization of the myometrium to produce contractions, and ripening (softening and dilation) of the cervix. A synthetic Prostaglandin misoprostol is fundamental to both of these changes. Low dose misoprostol is effective and safe for labor induction and has been used widely.

Oral tablets(200mcg) are broken into fragments and used intravaginally to ripen the cervix and induce labor due to the disadvantages of existing cervical ripeners (delivery of bolus doses, freezer or refrigerated storage, lack of efficacy in labor induction), and due to safety concerns with the off-label use of oral misoprostol tablet fragments, Regenex Corporation has developed a vaginal tablet with 25mcg misoprostol.

The primary objective of the study was to assess of the efficacy and safety of low dose (25 mcg) of misoprostol vaginal tablet for cervical ripening and induction of labour. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01428037
Study type Interventional
Source Regenex Pharmaceutical, China
Contact
Status Completed
Phase Phase 3
Start date March 2012
Completion date January 2013

See also
  Status Clinical Trial Phase
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Active, not recruiting NCT06324279 - Cervical Sliding Sign to Predict Outcome of Induction of Labor
Recruiting NCT05864326 - Heated Saline in Cervical Balloon for Labor Induction, a RCT N/A
Active, not recruiting NCT06056141 - Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter Phase 4
Completed NCT04529837 - Ultrasound Assessment of DILAPAN-S
Completed NCT02477085 - Methods of Labor Induction and Perinatal Outcomes
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Completed NCT00451308 - Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml Phase 4
Not yet recruiting NCT05511727 - Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening N/A
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Completed NCT01283022 - Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study) Phase 2
Recruiting NCT00684606 - Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor N/A
Recruiting NCT05759364 - The Effect of IV PAPAVERINE 80 mg Prior to Catheter Balloon Insertion on Bishop Score and Pain N/A
Recruiting NCT03854383 - Using Isosorbide Mononitrate in Reducing Time in Induction of Labor in Post Date Women Phase 2
Terminated NCT03752073 - Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix N/A
Recruiting NCT03045939 - Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours N/A
Completed NCT03976037 - Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb Early Phase 1