NCT06968481尚未招募2 期
Phase 2, Open-label, Randomized, Dose Ascending Trial to Evaluate the Efficacy and Safety of Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage Caused by Uterine Atony in Term Pregnant Women With Uncomplicated Vaginal Delivery
Insud Pharma1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2026年5月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Proportion of participants with a satisfactory uterine tone and cumulative blood loss < 500 ml
研究概览
简要总结
An open-label, randomized, single-center, dose ascending trial will be conducted to evaluate the efficacy and safety of sublingual oxytocin for the prevention of post-partum hemorrhage caused by uterine atony in term pregnant women having an uncomplicated vaginal delivery.
详细描述
The primary objective is to estimate the optimal effective dose (ED90) of sublingual oxytocin administered during the active management of the third stage of labor to result in satisfactory uterine tone and a cumulative blood loss < 500 ml at 20 minutes after vaginal delivery in 90% of parturients with an acceptable safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women willing and able to provide Informed consent.
- •Women who are able to understand, confirm and give informed consent during an antenatal visit or first stage of labor (cervical dilation <6 cm).
- •Healthy, primiparous or multiparous (2-4 deliveries), term-pregnant female with a gestational age of 37 to 42 weeks (inclusive). Gestational age should be confirmed with an obstetrical ultrasound if available.
- •Aged between 18 and 40 years (both inclusive).
- •Confirmed singleton pregnancy.
- •Based on the Investigator assessment, maternal and fetal conditions are met to expect a vaginal delivery.
- •For participants in the PK subgroup: women with baseline hemoglobin level ≥11 g/dL.
排除标准
- •Women who are unable to provide written Informed consent.
- •Women undergoing an elective or emergency cesarean section.
- •Conditions predisposing to uterine atony and PPH (e.g., previous PPH, placenta praevia, multiple gestation, severe pre-eclampsia, polyhydramnios, uterine fibroids, need for induction of labor, bleeding diathesis, sepsis, body mass index [BMI] ˃ 30 kg/m2 , macrosomia with estimated fetal weight >4500 g, if antenatal ultrasound was performed).
- •Women with moderate or severe anemia (defined as Hb <10 g/dL).
- •Women who have undergone female genital mutilation.
- •Known allergies to carbetocin, other oxytocin homologues or excipients in the medicinal products used in the trial.
- •Oral conditions before administration of sublingual oxytocin such as moderate erythema and edema, severe irritation/inflammation, moderate or severe abrasion.
- •Conditions predisposing to myocardial ischemia due to pre-existing cardiovascular diseases (such as hypertrophic cardiomyopathy, valvular heart disease and/or ischemic heart disease, including vasospasm of the coronary arteries) or known long QT syndrome or related symptoms.
- •Any clinically significant abnormality following review of medical history, laboratory result and physical examination at screening as judged by the Investigator (e.g., severe anemia, antepartum hemorrhage, mental disorder, history of cervical cancer or history of severe infection of the uterus, religious beliefs prohibiting blood transfusions).
- •Previous surgery of the cervix or uterus or any other preexisting condition that could interfere with the measurement of uterine contractility.
- •Current use or use within 30 days before the start of the IMP or reference product of one or more of predefined medications
研究组 & 干预措施
Sublingual Oxytocin
Experimental
sublingual administration of oxytocin
干预措施: Oxytocin sublingual (Drug)
Intramuscular Oxytocin
Other
Reference product is intramuscular administration of oxytocin
干预措施: Oxytocin IM (Drug)
结局指标
主要结局
Proportion of participants with a satisfactory uterine tone and cumulative blood loss < 500 ml
时间窗: From administration of the drug to 20 minutes post-partum
次要结局
- Measurement of blood loss(3 min, 5 min, 10 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 12 hours and 24 hours after administration of the drug)
- Proportion of participants who develop primary PPH(Up to 24 hours after administration of the drug)
- Incidence of laparotomy for the treatment of PPH(At 24 hours after administration of the drug)
- Proportion of participants that achieve cessation of active bleeding(Within 20 minutes after administration of the drug)
- Time to PPH onset(Immediately after the intervention up to 24 hours post intervention)
- Time to active bleeding cessation(Immediately after the intervention up to 24 hours post intervention)
- Proportion of participants with satisfactory uterine tone(after 3 min, 5 min, 10 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 12 hours and 24 hours after administration of the drug)
- Incidence of blood transfusion due to PPH(At 24 hours after administration of the drug)
- Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)(From the time of written informed consent until the End of Study visit and must be followed up until resolution or stabilization)
- Absolute number and percentage of participants with oral irritation/inflammation and abrasion(after admission to hospital (during the Latent or Active phase for all participants) and at 20 minutes and 24 hours post dose for participants who are administered the investigational drug)
研究者
研究点 (1)
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