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

NCT05828966 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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)

Conditions

Preterm Labor

Outcome Measures

Primary Outcomes (1)

• 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

  48 hours

Study Arms (2)

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.

Drug: human chorionic gonadotropin (hCG)

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.

Drug: Magnesium sulfate

Interventions

human chorionic gonadotropin (hCG) DRUG

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.

HUMAN CHORIONIC GONADOTROPIN (HCG) Group

Magnesium sulfate DRUG

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

Magnesium Sulphate(MgSO4) Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only pregnant females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%.

You may not qualify if:

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

Sponsors & Collaborators

• Shaheed Zulfiqar Ali Bhutto Medical University: lead

Study Sites (1)

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

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Chorionic Gonadotropin; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Gynecology and Obstetrics

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: April 25, 2023
• Study Start: February 15, 2023
• Primary Completion: May 15, 2023
• Study Completion: December 20, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

PA (1)