Induction of Labor Clinical Trial
Official title:
A Multicenter, Open-Label, Phase II Study of the 200 mcg Misoprostol Vaginal Insert (MVI 200) to Obtain Pharmacokinetics in Women at Term Gestation (The MVI-PK Study)
Verified date | March 2014 |
Source | Ferring Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine the pharmacokinetics (PK) of misoprostol acid for the MVI 200 in women requiring cervical ripening and induction of labor.
Status | Completed |
Enrollment | 24 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Provide written informed consent; - Pregnant women at = 36 weeks 0 days inclusive gestation; - Women aged 18 years or older; - Candidate for pharmacologic induction of labor; - Single, live vertex fetus; - Baseline modified Bishop score = 4; - Parity = 3 (parity is defined as one or more births live or dead after 24 weeks gestation); - Body Mass Index (BMI) = 50 at the time of entry to the study. Exclusion Criteria: - Women with hemoglobin level < 10.0 grams per deciliter (g/dL) (confirmed within one week of study drug insertion); - Women in active labor; - Presence of uterine or cervical scar or uterine abnormality e.g., bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted; - Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or gestational hypertension; - Severe pre-eclampsia marked by Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP) syndrome, other end-organ affliction or Central Nervous System (CNS) findings other than mild headache; - Fetal malpresentation; - Diagnosed congenital anomalies, not including polydactyly; - Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining); - Amnioinfusion or other treatment of non-reassuring fetal status at any time prior to the induction attempt; - Ruptured membranes = 48 hours prior to the start of treatment; - Suspected chorioamnionitis; - Fever (oral or aural temperature > 37.5°C); - Any condition in which vaginal delivery is contraindicated e.g., placenta previa or any unexplained genital bleeding at any time after 24 weeks during this pregnancy; - Known or suspected allergy to misoprostol, other prostaglandins or any of the excipients; - Any condition urgently requiring delivery; - Unable to comply with the protocol. |
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Huntington Memorial Hospital | Pasadena | California |
Lead Sponsor | Collaborator |
---|---|
Ferring Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time of Maximum Plasma Concentration (Tmax) of Misoprostol After Insertion | The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 0.5,1, 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5 and 1 hour after removal of the study drug. The 10 hour and 14 hour blood samples were obtained if the subject still had the study drug in place at those timepoints. | From study drug insertion up to 1 hour post study drug removal. | No |
Primary | Maximum Plasma Concentration (Cmax) of Misoprostol up to 1 Hour Post Study Drug Removal | The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 0.5,1, 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5 and 1 hour after removal of the study drug. The 10 hour and 14 hour blood samples were obtained if the subject still had the study drug in place at those timepoints. | From study drug insertion up to 1 hour post study drug removal | No |
Secondary | Rate of Adverse Events. | All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events. | From study drug administration to hospital discharge (approximately 48-72 hours). | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01127581 -
Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery
|
Phase 3 | |
Completed |
NCT01139801 -
Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon
|
N/A | |
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
|
||
Completed |
NCT03138252 -
Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin
|
Phase 3 | |
Completed |
NCT02098421 -
Foley Labor Induction Trial at Term and in PROM
|
Phase 1 | |
Recruiting |
NCT01720394 -
Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert
|
Phase 4 | |
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 | |
Recruiting |
NCT02762942 -
Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor
|
Phase 4 | |
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 | |
Completed |
NCT01428037 -
Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor
|
Phase 3 | |
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 |