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临床试验/NCT05828966
NCT05828966已完成不适用

HUMAN CHORIONIC GONADOTROPIN (HcG) VS MAGNESIUM SULPHATE (MgSo4) AS A TOCOLYTIC AGENT- A RANDOMIZED CONTROLLED TRIAL

Shaheed Zulfiqar Ali Bhutto Medical University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年2月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Tocolysis

研究概览

简要总结

Preterm labor is defined as regular contractions of the uterus resulting in changes in the cervix (effacement and dilatation) that start before 37 weeks of pregnancy. (1) Although preterm labor constitutes only 10% of total labors, yet 70% of infant's mortality is related to prematurity. It is therefore one of the international indices in assessment of health condition worldwide. Human Chorionic Gonadotropin (H.C.G.) is a heterodimeric glycoprotein produced primarily in the placenta and has multiple endocrines, paracrine and immunoregulatory actions. (3) The importance of H.C.G. in maintenance of early pregnancy has been widely accepted, reports have highlighted a potential role of H.C.G. in maintaining uterine quiescence in the third trimester. H.C.G. exerts a potent concentration dependent inhibitory effect on human myometrial contractions. (4) Recent data suggests that H.C.G. might have a role as an endogenous tocolytic agent in normal pregnancy. A significant decrease in serum H.C.G. level was found 2-3 weeks before the spontaneous onset of labour. This might contribute to increasing the contractility in the uterine muscle and gradually initiating the onset of labour. (5)

详细描述

Preterm labor is defined as regular contractions of the uterus resulting in changes in the cervix (effacement and dilatation) that start before 37 weeks of pregnancy. (1) Although preterm labor constitutes only 10% of total labors, yet 70% of infant's mortality is related to prematurity. It is therefore one of the international indices in assessment of health condition worldwide. Factors that increase the risk of preterm birth include history of previous preterm birth, short cervix, short time between pregnancies, teenage pregnancy, history of certain types of surgery on the uterus or cervix, certain pregnancy complications, such as multiple pregnancy and vaginal bleeding and lifestyle factors such as low pre-pregnancy weight, smoking during pregnancy, and substance abuse during pregnancy.

Preterm labor can be diagnosed clinically only when changes in the cervix are found after pelvic examination along with contractions also may be monitored. A transvaginal ultrasound exam may be done to measure the length of your cervix. Tocolytics are drugs used to delay delivery for a short time (up to 48 hours). They may allow time for corticosteroids or magnesium sulfate to be given or for you to be transferred to a hospital that offers specialized care for preterm infants. (1,2) Tocolytic agents are β- HCG, MgSO4, nifedipine, β-agonists(salbutamol) and atosiban. Use of salbutamol is of limited use because of many cardiovascular complications i.e., ventricular arrythmia, hypertension and hyperglycemia while atosiban is expensive and not available in Pakistan.

Human Chorionic Gonadotropin (H.C.G.) is a heterodimeric glycoprotein produced primarily in the placenta and has multiple endocrines, paracrine and immunoregulatory actions. (3) The importance of H.C.G. in maintenance of early pregnancy has been widely accepted, reports have highlighted a potential role of H.C.G. in maintaining uterine quiescence in the third trimester. H.C.G. exerts a potent concentration dependent inhibitory effect on human myometrial contractions. (4) Recent data suggests that H.C.G. might have a role as an endogenous tocolytic agent in normal pregnancy. A significant decrease in serum H.C.G. level was found 2-3 weeks before the spontaneous onset of labour. This might contribute to increasing the contractility in the uterine muscle and gradually initiating the onset of labour. (5) Following I.M. injection, peak concentration of H.C.G. occurs about 6 hrs after a dose. It is distributed primarily to gonads. Blood concentration declines in a biphasic manner, with a half-life between about 6 and 11 hrs and 23 to 38 hrs respectively. About 10 to 12% of an IM dose is excreted in urine within 24 hours. (6)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 4 uterine contractions per 20 min or 8 contractions per hour
  • single live fetus
  • Pregnancy less than 37 weeks
  • Intact Membranes,
  • Dilatation less than 3cm and effacement less than 80%.

排除标准

  • Cervical Dilatation more than 4 cm
  • Abnormal vaginal bleeding
  • Premature Rupture of membranes
  • Cardiopulmonary compromised
  • Fetal and Uterine anomalies

研究组 & 干预措施

HUMAN CHORIONIC GONADOTROPIN (HCG) Group

Active Comparator

H.C.G. will be given in Group A and in a dose of 5000units intramuscular injection followed by a drip of 10,000 units in 500ml of dextrose 5%, at the rate of 20 drops per minute. Half hourly assessment of uterine contractions, maternal vital signs, fetal heart rate monitoring will be done.

干预措施: human chorionic gonadotropin (hCG) (Drug)

Magnesium Sulphate(MgSO4) Group

Active Comparator

4gm of MgSO4 will be given in Group B as intravenously as continuous dose followed by 2gm/hr till uterine quiescence is achieved.

干预措施: Magnesium sulfate (Drug)

结局指标

主要结局

Tocolysis

时间窗: 48 hours

Tocolysis will be considered successful when contractions ceased and delivery will be delayed by 48 hrs giving time to the administered corticosteroids to accelerate fetal lung maturation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hafiza Faiza Mushtaq

Resident in Gynecology and Obstetrics

Shaheed Zulfiqar Ali Bhutto Medical University

研究点 (1)

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