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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Time of Maximum Plasma Concentration (Tmax) of Misoprostol After Insertion
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
MVI 200
MVI 200 mcg vaginal insert
干预措施: MVI 200 (Drug)
结局指标
主要结局
Time of Maximum Plasma Concentration (Tmax) of Misoprostol After Insertion
时间窗: From study drug insertion 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.
Maximum Plasma Concentration (Cmax) of Misoprostol up to 1 Hour Post Study Drug Removal
时间窗: From study drug insertion 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.
次要结局
- Rate of Adverse Events.(From study drug administration to hospital discharge (approximately 48-72 hours).)