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

Primary Purpose

Preterm Labor

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
human chorionic gonadotropin (hCG)
Magnesium sulfate
Sponsored by
Shaheed Zulfiqar Ali Bhutto Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Labor

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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%. Exclusion Criteria: Cervical Dilatation more than 4 cm Abnormal vaginal bleeding Premature Rupture of membranes Cardiopulmonary compromised Fetal and Uterine anomalies

Sites / Locations

  • Mother and Child Care Hospital, Shaheed Zulfiqar Ali Bhutto Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HUMAN CHORIONIC GONADOTROPIN (HCG) Group

Magnesium Sulphate(MgSO4) Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Tocolysis
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

Secondary Outcome Measures

Full Information

First Posted
April 13, 2023
Last Updated
August 15, 2023
Sponsor
Shaheed Zulfiqar Ali Bhutto Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05828966
Brief Title
HUMAN CHORIONIC GONADOTROPIN (HcG) VS MAGNESIUM SULPHATE (MgSo4) AS A TOCOLYTIC AGENT- A RANDOMIZED CONTROLLED TRIAL
Official Title
HUMAN CHORIONIC GONADOTROPIN (HcG) VS MAGNESIUM SULPHATE (MgSo4) AS A TOCOLYTIC AGENT- A RANDOMIZED CONTROLLED TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
May 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shaheed Zulfiqar Ali Bhutto Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 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)
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 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HUMAN CHORIONIC GONADOTROPIN (HCG) Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Magnesium Sulphate(MgSO4) Group
Arm Type
Active Comparator
Arm Description
4gm of MgSO4 will be given in Group B as intravenously as continuous dose followed by 2gm/hr till uterine quiescence is achieved.
Intervention Type
Drug
Intervention Name(s)
human chorionic gonadotropin (hCG)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate
Intervention Description
4gm of MgSO4 will be given in Group B as intravenously as continuous dose followed by 2gm/hr till uterine quiescence is achieved.
Primary Outcome Measure Information:
Title
Tocolysis
Description
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
Time Frame
48 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only pregnant females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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%. Exclusion Criteria: Cervical Dilatation more than 4 cm Abnormal vaginal bleeding Premature Rupture of membranes Cardiopulmonary compromised Fetal and Uterine anomalies
Facility Information:
Facility Name
Mother and Child Care Hospital, Shaheed Zulfiqar Ali Bhutto Medical University
City
Islamabad
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
I have not decided yet .

Learn more about this trial

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

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