Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05828966
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2023-04-13
Brief Title:
HUMAN CHORIONIC GONADOTROPIN HcG VS MAGNESIUM SULPHATE MgSo4 AS A TOCOLYTIC AGENT- A RANDOMIZED CONTROLLED TRIAL
Sponsor:
Shaheed Zulfiqar Ali Bhutto Medical University
Organization:
Shaheed Zulfiqar Ali Bhutto Medical University
Study Overview
Official Title:
HUMAN CHORIONIC GONADOTROPIN HcG VS MAGNESIUM SULPHATE MgSo4 AS A TOCOLYTIC AGENT- A RANDOMIZED CONTROLLED TRIAL
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 infants mortality is related to prematurity It is therefore one of the international indices in assessment of health condition worldwide Human Chorionic Gonadotropin HCG is a heterodimeric glycoprotein produced primarily in the placenta and has multiple endocrines paracrine and immunoregulatory actions 3 The importance of HCG in maintenance of early pregnancy has been widely accepted reports have highlighted a potential role of HCG in maintaining uterine quiescence in the third trimester HCG exerts a potent concentration dependent inhibitory effect on human myometrial contractions 4 Recent data suggests that HCG might have a role as an endogenous tocolytic agent in normal pregnancy A significant decrease in serum HCG 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
Detailed Description:
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 infants 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 12 Tocolytic agents are β- HCG MgSO4 nifedipine β-agonistssalbutamol and atosiban Use of salbutamol is of limited use because of many cardiovascular complications ie ventricular arrythmia hypertension and hyperglycemia while atosiban is expensive and not available in Pakistan
Human Chorionic Gonadotropin HCG is a heterodimeric glycoprotein produced primarily in the placenta and has multiple endocrines paracrine and immunoregulatory actions 3 The importance of HCG in maintenance of early pregnancy has been widely accepted reports have highlighted a potential role of HCG in maintaining uterine quiescence in the third trimester HCG exerts a potent concentration dependent inhibitory effect on human myometrial contractions 4 Recent data suggests that HCG might have a role as an endogenous tocolytic agent in normal pregnancy A significant decrease in serum HCG 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 IM injection peak concentration of HCG 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
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 12 Tocolytic agents are β- HCG MgSO4 nifedipine β-agonistssalbutamol and atosiban Use of salbutamol is of limited use because of many cardiovascular complications ie ventricular arrythmia hypertension and hyperglycemia while atosiban is expensive and not available in Pakistan
Human Chorionic Gonadotropin HCG is a heterodimeric glycoprotein produced primarily in the placenta and has multiple endocrines paracrine and immunoregulatory actions 3 The importance of HCG in maintenance of early pregnancy has been widely accepted reports have highlighted a potential role of HCG in maintaining uterine quiescence in the third trimester HCG exerts a potent concentration dependent inhibitory effect on human myometrial contractions 4 Recent data suggests that HCG might have a role as an endogenous tocolytic agent in normal pregnancy A significant decrease in serum HCG 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 IM injection peak concentration of HCG 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None