NCT03067597已完成3 期
A Multicentre, Open-label Phase III Trial Investigating the Efficacy and Safety of FE 999901 Vaginal Insert in Pregnant Women at Term (≥37 Weeks and <41 Weeks of Gestation) Requiring Cervical Ripening
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 14
- 主要终点
- The proportion of women with cervical ripening success
研究概览
简要总结
To demonstrate the efficacy of controlled-release dinoprostone vaginal insert (DVI) for cervical ripening success (either Bishop Score (BS) ≥7 or vaginal delivery) within 12 hours of vaginal insert administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women at term (≥37 weeks 0 day and < 41 weeks 0 day of gestation) at the Baseline visit
- •Candidate for pharmacologic induction of labour
- •Singleton pregnancy with live infant in vertex presentation
- •Baseline BS ≤ 4 at the Baseline visit
- •Parity ≤ 3 (parity is defined as one or more births live or stillbirths after 22 weeks 0 day gestation)
- •Written informed consent
排除标准
- •Women in active labour
- •Presence of uterine or cervical scar including scar from previous caesarean section, and previous cone biopsy of the cervix and loop electrosurgical excision procedure (LEEP)
- •Uterine abnormality e.g. bicornuate uterus
- •Administration of oxytocin, any cervical ripening or labour inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to IMP administration. Magnesium sulfate is permitted if prescribed as treatment for preeclampsia or pregnancy induced hypertension
- •Presence of the following conditions/symptoms:
- •Systolic blood pressure > 160 mmHg or diastolic blood pressure > 110 mmHg. Platelets < 100,000/µL. Increased liver function tests (2x upper limits of normal range). Severe, persistent right upper quadrant/epigastric pain. Progressive renal insufficiency: Creatinine > 1.1 mg/dL, Doubling of creatinine in the absence of other renal disease. Pulmonary edema. New onset cerebral or visual disturbances.
- •Suspected or confirmed cephalopelvic disproportion and/or fetal malpresentation
- •Diagnosed congenital abnormalities, not including polydactyly
- •Suspected or confirmed intrauterine growth retardation (≤ mean 1.5 SD of normal estimated fetal weight for dates)
- •Any evidence of fetal compromise at Baseline visit (e.g., non-reassuring fetal heart rate pattern, meconium staining, history of non-reassuring fetal status or abnormal umbilical artery Doppler wave form)
- •Intake of medication with aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) at V2
- •Ruptured membranes ≥ 48 hours prior to IMP administration
- •Suspected clinical chorioamnionitis
- •Current pelvic inflammatory disease, unless adequate prior treatment has been instituted
- •Fever (axillary temperature ≥ 38.0°C) at the Baseline visit
- •Any condition in which vaginal delivery is contraindicated (e.g., placenta previa or any unexplained vaginal bleeding at any time after 24 weeks 0 day during this pregnancy)
- •Known or suspected allergy to, dinoprostone, other prostaglandins or any constituent of IMP
- •Any condition urgently requiring delivery
- •History of asthma or glaucoma
- •Unable to comply with the protocol
- •Any other medical condition which in the judgement of the investigators would impair participation in the trial
研究组 & 干预措施
Dinoprostone vaginal insert (DVI)
Experimental
干预措施: Dinoprostone (Drug)
结局指标
主要结局
The proportion of women with cervical ripening success
时间窗: Within 12 hours of vaginal insert administration
Defined as either Bishop Score (BS) ≥7 or a vaginal delivery
次要结局
- Change in maternal parameters of haematology, clinical chemistry and urinalysis(From baseline to end of trial (expected average of up to 1 week))
- Proportion of subjects delivering vaginally(Within the first admission to hospital)
- Proportion of subjects who receive pre-delivery oxytocic drugs and dose of pre-delivery oxytocic drugs(From the IMP removal to delivery)
- Proportion of subjects with BS ≥7(At onset of labour)
- Type, frequency and intensity of intrapartum adverse events (AEs), postpartum AEs and neonatal AEs(From obtaining the informed consent through end of trial (expected average of up to 1 week))
- Change in maternal parameters of vital signs (blood pressure, heart rate and body temperature)(From baseline through end of trial (expected average of up to 1 week))
- Proportion of nulliparous and multiparous subjects with cervical ripening success(Within 12 hours of Investigational Medicinal Product (IMP) administration)
- Proportion of subjects who undergo mechanical cervical ripening(At least 60 minutes after the removal of the IMP)
- Duration of mechanical cervical ripening for subjects who undergo mechanical cervical ripening(Time from at least 60 minutes after the removal of the IMP until end of any mechanical ripening)
- Proportion of neonates with Apgar Score <7(5 minutes post-birth)
- pH in umbilical artery blood samples(At birth)
- Proportion of subjects with a BS increase ≥3 points from baseline(Within 12 hours of IMP administration)
- Time from IMP administration to vaginal delivery, caesarean delivery and any delivery(Interval from IMP administration to delivery)
- Rate of admission to neonatal intensive care unit (NICU) for at least 24 hours(After delivery)
- Time from IMP administration to onset of active labour(Interval from IMP administration to onset of active labour)
- Proportion of subjects who have a caesarean delivery within the first admission to hospital(At time of delivery)
- Type, frequency and intensity of intrapartum AEs(From obtaining the informed consent to the removal of the IMP)
研究者
研究点 (14)
Loading locations...
相似试验
已完成
3 期
A Randomised Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at TermCervical RipeningNCT03067727Ferring Pharmaceuticals114
已完成
不适用
Trial of Cervical Ripening and Labor Induction Using Misoprostol With or Without Intravaginal Isosorbide MononitrateCervical RipeningNCT00374621Stanford University156
Unknown
3 期
Preoperative Vaginal Dinoprostone Prior to Abdominal MyomectomyMyomectomyNCT04080375Cairo University100
已完成
3 期
Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of LaborCervical RipeningLabor, InducedNCT00308711Ferring Pharmaceuticals1,308
招募中
不适用
Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)Induction of Labor Affected Fetus / NewbornNCT05759988University of Pennsylvania2,300