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Completed

NCT Number: NCT05688007

The Association Between Parathyroid Hormone and Preterm Labor

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?

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Ain Shams Maternity Hospital

Cairo, Egypt

About this study

  • 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:

  • Cases: established preterm labor - gestational age: (28-36 weeks)
  • 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  • Venous blood samples will be withdrawn about (3ml) once from every patient within one hour from inclusion into the study to measure serum parathyroid hormone, calcium, magnesium, phosphorus and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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

parathyroid hormone level

Diagnostic Test

Serum level of parathyroid hormone

serum electrolytes

Diagnostic Test

Serum levels of: magnesium, phosphorus, calcium, and albumin

Primary outcomes

  1. parathyroid hormone

    Time frame: 1 day

    serum level of parathyroid hormone (ng/L)

Secondary outcomes

  1. Calcium

    Time frame: 1 day

    serum calcium level (mg/dl)

  2. Magnesium

    Time frame: 1 day

    serum magnesium level (meq/L)

  3. Phosphorus

    Time frame: 1 day

    serum phosphorus level (mg/dl)

  4. Albumin

    Time frame: 1 day

    serum albumin level (g/dl)

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2023
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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