The Association Between Parathyroid Hormone and Preterm Labor
Condition: Preterm Labor; Parathyroid Diseases
MeSH terms: Premature Birth; Obstetric Labor, Premature; Parathyroid Diseases
Study type: Observational

Summary: 
      This observational study aims to test the level of parathyroid hormone in pregnant women. The
      main question it aims to answer is:

      n Pregnant women, are the levels of serum PTH, calcium, magnesium, phosphorus & albumin
      similar in both preterm and term births?
    

Detailed description: 
      -  Approval from ethical committee will be sought.

        -  Patients will be enrolled from Ain Shams University Maternity Hospital labor ward and
           antenatal outpatient clinic.

        -  History, examination and fetal ultrasound will be done to identify eligible patients.

      History: a full detailed history including personal, menstrual, obstetric, present, past
      history and family history will be obtained.

      Accurate last menstrual period date will be obtained, and gestational age will be calculated
      using Naegele's rule or first trimester ultrasound to identify preterm patients with
      gestational age (28-36 weeks).

      Examination: general, abdominal and vaginal examination to identify patients in established
      labor with Regular uterine contractions are at least 3 in 10 min each lasting 40 seconds.
      Progressive cervical dilatation (at least 4 cm). Ultrasound: for (viability of fetus, fetal
      biometry and estimated fetal weight, amniotic fluid, placental localization).

      Thus, two groups of patients will be identified:

        1. Cases: established preterm labor - gestational age: (28-36 weeks)

        2. Controls: pregnant women not in labor - gestational age: (28- 36 weeks)

             -  Venous blood samples will be withdrawn about (3ml) once from every patient within
                one hour from inclusion into the study to measure serum parathyroid hormone,
                calcium, magnesium, phosphorus and albumin levels.

             -  Samples will not be collected from an arm with an intravenous catheter if alternate
                sites are available.

             -  Patient collection site will be appropriately disinfected prior to sample
                collection.

             -  After collection, samples will be put in a red or yellow tube (serum separating
                tube) with a serum gel separator.

             -  Samples will be gently mixed immediately following collection into tube to ensure
                proper preservation of the analytes. 180° tube inversion, allowing bubble to travel
                the length of the tube, followed by return to upright position is one mix.

             -  Samples will be delivered to laboratory within 30 to 60 minutes.

             -  Data will be collected and recorded in a case report form (Age, parity, previous
                preterm births/ miscarriage, gestational age, measured levels of serum PTH,
                calcium, magnesium, phosphorus & albumin , mode of delivery, birth weight).

             -  Statistical analysis will be done to get results.
    

Intervention name(s): parathyroid hormone level; serum electrolytes
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Serum level of parathyroid hormone; Serum levels of: magnesium, phosphorus, calcium, and albumin
Intervention MeSH terms: Hormones; Parathyroid Hormone
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women attending Ain Shams University Maternity Hospital (labor ward and antenatal
        outpatient clinic)
      
Keywords: parathyroid hormone; calcium, magnesium, phosphorus, albumin