Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Cytokine PharmaSciences |
---|---|
Information provided by: | Cytokine PharmaSciences |
ClinicalTrials.gov Identifier: | NCT00346840 |
The primary objective of the study was assessment of the efficacy of four dose reservoirs (25 mcg, 50 mcg, 100 mcg, 200 mcg) of intravaginal controlled release misoprostol administered for up to 24 hours. Efficacy was measured in terms of time from insert placement to vaginal delivery.
Condition | Intervention | Phase |
---|---|---|
Labor Induction Cervical Ripening |
Drug: Misoprostol vaginal insert 25 mcg Drug: Misoprostol vaginal insert 50 mcg Drug: Misoprostol vaginal insert 100 mcg Drug: Misoprostol vaginal insert 200 mcg |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Controlled-Release Misoprostol Vaginal Insert in Parous Women for Labor Induction: Randomized Trial |
Estimated Enrollment: | 140 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | March 2004 |
Approximately 20% of pregnant women require medical intervention to induce labour for reasons including post-date pregnancy, pre-eclampsia, maternal diabetes, premature rupture of the membranes and intra-uterine fetal growth retardation. There are two fundamental changes that characterise pre-labour preparation for delivery: sensitisation of the myometrium to produce contractions, and ripening (softening and dilation) of the cervix. Prostaglandins (PG) are fundamental to both of these changes, and several forms have been used to successfully induce labour. Dinoprostone (PGE2) is an example of a cervical ripening agent that is available in gel and tablet form and has a proven record of successful cervical ripening in this population. Dinoprostone is also available in a controlled release vaginal delivery system, which is manufactured by Controlled Therapeutics (Scotland) a subsidiary of Cytokine PharmaSciences, Inc., King of Prussia, PA, USA.
Another synthetic prostaglandin that has been shown to be an effective cervical ripener and labour inducer is misoprostol. Oral tablets are broken into fragments and used intravaginally to ripen the cervix and induce labour Due to the disadvantages of existing cervical ripeners (delivery of bolus doses, freezer or refrigerated storage, lack of efficacy in labour induction), and due to safety concerns with the off-label use of oral misoprostol tablet fragments, Controlled Therapeutics has developed a controlled release vaginal delivery system similar to its marketed dinoprostone product but containing misoprostol.
This study examines four dose strengths of the misoprostol vaginal insert in women who need to have their labours induced.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Liverpool Women's Hospital | |
Liverpool, United Kingdom, L8 7SS | |
The Queen's Mother's Hospital | |
Yorkhill, Glasgow, United Kingdom, G12 9TZ | |
King George Hospital | |
Ilford, United Kingdom, IG3 8YB | |
Birmingham Women's Hospital | |
Birmingham, United Kingdom, B13 9HP | |
Princess Royal Maternity Hospital | |
Glasgow, United Kingdom, G11 5DY | |
Northampton General Hospital | |
Northampton, United Kingdom, NN1 5BD |
Study Director: | Helen Colquhoun, MD | Pleiad, Inc. |
Study ID Numbers: | Miso-Obs-002 |
Study First Received: | June 29, 2006 |
Last Updated: | December 5, 2006 |
ClinicalTrials.gov Identifier: | NCT00346840 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Labor induction cervical ripening misoprostol vaginal insert |
Misoprostol |
Oxytocics Therapeutic Uses Anti-Ulcer Agents Physiological Effects of Drugs Abortifacient Agents |
Gastrointestinal Agents Reproductive Control Agents Abortifacient Agents, Nonsteroidal Pharmacologic Actions |