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The Association Between Parathyroid Hormone and Preterm Labor

The Association Between Parathyroid Hormone and Preterm Labor

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05688007
Enrollment
100
Registered
2023-01-18
Start date
2021-04-01
Completion date
2022-12-30
Last updated
2023-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Labor, Parathyroid Diseases

Keywords

parathyroid hormone; calcium, magnesium, phosphorus, albumin

Brief 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 Controls: pregnant women not in labor - gestational age: (28- 36 weeks) * Venous blood samples will be withdrawn about (3ml) once from every patient within one hour from inclusion into the study to measure serum parathyroid hormone, calcium, magnesium, phosphorus and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.

Interventions

Serum level of parathyroid hormone

DIAGNOSTIC_TESTserum electrolytes

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

Sponsors

Ain Shams Maternity Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
parathyroid hormone1 dayserum level of parathyroid hormone (ng/L)

Secondary

MeasureTime frameDescription
Calcium1 dayserum calcium level (mg/dl)
Magnesium1 dayserum magnesium level (meq/L)
Phosphorus1 dayserum phosphorus level (mg/dl)
Albumin1 dayserum albumin level (g/dl)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026