NCT00528255撤回2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
PK study in women requiring cervical ripening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
1
Experimental
干预措施: Misoprostol Vaginal Insert (MVI 100) (Drug)
结局指标
主要结局
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.
时间窗: 24 Hours
次要结局
- -The levels of misoprostol acid in plasma at time of removal, and 30 and 60 minutes post removal. -Assess all adverse events.(24h)
研究者
研究点 (6)
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