HUMAN CHORIONIC GONADOTROPIN (HcG) VS MAGNESIUM SULPHATE (MgSo4) AS A TOCOLYTIC AGENT- A RANDOMIZED CONTROLLED TRIAL
Condition: Preterm Labor
MeSH terms: Obstetric Labor, Premature
Study type: Interventional

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)
    

Intervention name(s): human chorionic gonadotropin (hCG); Magnesium sulfate
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 4gm of MgSO4 will be given in Group B as intravenously as continuous dose followed by 2gm/hr till uterine quiescence is achieved.
Intervention MeSH terms: Magnesium Sulfate; Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment