Clinical trial NCT00528255: Pharmacokinetics and Safety of the 100 Mcg Misoprostol Vaginal Insert (MVI 100)
Official title: A Multicenter, Open-Label, Phase II Study of the Pharmacokinetics and Safety of the100 Mcg Misoprostol Vaginal Insert (MVI 100) in Women Requiring Cervical Ripening and Induction of Labor
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cervical Ripening
Induction of Labor
Keywords: cervical ripening
induction of labor
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-09-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will provide pharmacokinetic data for the MVI 100 (100 mcg) misoprostol vaginal insert when administered to nulliparous women at term gestation requiring cervical ripening and induction of labor.

Detailed description: PK study in women requiring cervical ripening.

Eligibility criteria: Inclusion Criteria:

* Pregnant women at ≥36 weeks 0 days inclusive gestation;
* Aged 18 years or older;
* Candidate for pharmacologic induction of labor;
* Singleton pregnancy;
* Baseline modified Bishop score \<4 (see Appendix B);
* Nulliparous (nulliparous is defined as no previous births live or dead after 24 weeks gestation);
* Written informed consent.

Exclusion Criteria:

* Women with hemoglobin level \< 11.0 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 pregnancy inducted hypertension;
* Severe pre-eclampsia marked by CNS findings, HELLP syndrome, or other end-organ affliction;
* Suspected or confirmed cephalopelvic disproportion and/or fetal malpresentation;
* Diagnosed fetal abnormalities;
* Suspected or confirmed intrauterine growth retardation (less than 10% estimated fetal weight for dates);
* Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
* Receipt of NSAID (including aspirin) within 4 hours of study treatment;
* Ruptured membranes ≥48 hours prior to the start of treatment or suspected chorioamnionitis;
* Fever (oral or aural temperature \> 37.5C);
* 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, dinoprostone, other prostaglandins or any of the excipients;
* Any condition urgently requiring delivery;
* Unable to comply with the protocol.

Primary outcomes:
measure: The levels of misoprostol acid in plasma at time points 0 (baseline), 2, 4, 6, 8, 10 and 14 hours. Not all patients will have all in situ time points as the insert may be removed earlier for safety or efficacy reasons.
timeFrame: 24 Hours
Secondary outcomes:
measure: -The levels of misoprostol acid in plasma at time of removal, and 30 and 60 minutes post removal. -Assess all adverse events.
timeFrame: 24h
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Paradise Valley Hospital
state: Arizona
city: Long Beach
country: United States
facility: Long Beach Memorial Hospital
state: California
city: Orange
country: United States
facility: UCI Medical Center
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: West Jordan
country: United States
facility: Jordan Valley Hospital
state: Utah
Study officials:
affiliation: Precision Trials
name: Steven Wininger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: South Valley Women's Research
name: Arlen Jarrett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCI Medical Center/Long Beach Memorial Hospital
name: Deborah Wing, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University Hospital
name: Raymond Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Santa Clara Valley Medical Center
name: James Byrne, MD
role: PRINCIPAL_INVESTIGATOR
References: