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

What Was Tested

In this not phased trial, researchers set out to test hCG (human chorionic gonadotropin).

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.

It is therefore one of the international indices in assessment of health condition worldwide.

It had two arms (groups): HUMAN CHORIONIC GONADOTROPIN (HCG) Group (active comparator) and Magnesium Sulphate(MgSO4) Group (active comparator).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

The registry lists 70 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 4 uterine contractions per 20 min or 8 contractions per hour. Single live fetus. Pregnancy less than 37 weeks.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: cervical dilatation more than 4 cm; abnormal vaginal bleeding; premature rupture of membranes.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got hCG (human chorionic gonadotropin) and who got the comparison, which limits bias.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

Everyone knew when hCG (human chorionic gonadotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-02-15 with completion listed for 2023-05-15.

It ran at 1 site in Pakistan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Tocolysis (time frame: 48 hours).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) in 70 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.