The Association Between Parathyroid Hormone and Preterm Labor

Ain Shams Maternity Hospital

Status: Completed

Conditions: Parathyroid Diseases; Preterm Labor

Treatments: Diagnostic Test: serum electrolytes; Diagnostic Test: parathyroid hormone level

Study type: Observational

Funder types: Other

Identifiers

NCT05688007

MS 168/2021

Details and patient eligibility

About

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?

Full 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   • Venous blood samples will be withdrawn about (3ml) once from every patient within one hour from inclusion into the study to measure serum parathyroid hormone, calcium, magnesium, phosphorus and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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women aged (18-40).
• Gestational age (28-36 weeks).

Exclusion criteria

• Known maternal disease as diabetes, hypertension, renal disease, cardiac disease and liver disease.
• Known hypo or hyperparathyroidism
• Multiple pregnancy
• Polyhydramnios
• Premature rupture of membrane
• Antepartum Hemorrhage
• Uterine malformations e.g. bicornuate uterus
• Smoking

Trial design

100 participants in 2 patient groups

Cases

Description:

pregnant women with established preterm labor - gestational age: (28-36 weeks), having: Regular uterine contractions are at least 3 in 10 min each lasting 40 seconds. Progressive cervical dilatation (at least 4 cm).

Treatment:

Diagnostic Test: parathyroid hormone level

Diagnostic Test: serum electrolytes

Controls

Description:

pregnant women not in labor - gestational age: (28- 36 weeks)

Treatment:

Diagnostic Test: parathyroid hormone level

Diagnostic Test: serum electrolytes