The Association Between Parathyroid Hormone and Preterm Labor

Completed

• Conditions: Preterm Labor; Parathyroid Diseases
• Interventions: Diagnostic Test: parathyroid hormone level; Diagnostic Test: serum electrolytes

• Registration Number: NCT05688007
• Lead Sponsor: Ain Shams Maternity Hospital

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* Venous blood samples will be withdrawn about (3ml) once from every patient within one hour from inclusion into the study to measure serum parathyroid hormone, calcium, magnesium, phosphorus and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

Study Timeline

• Study Start: 2021-04-01
• Primary Completion: 2022-10-16
• Study Completion: 2022-12-30
• Status Verified: 2023-01
• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-17
• Last Update Submitted: 2023-01-17
• Study First Posted: 2023-01-18
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	serum electrolytes	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).
Controls	parathyroid hormone level	pregnant women not in labor - gestational age: (28- 36 weeks)
Controls	serum electrolytes	pregnant women not in labor - gestational age: (28- 36 weeks)
Cases	parathyroid hormone level	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).

Primary Outcome Measures

Name	Time	Method
parathyroid hormone	1 day	serum level of parathyroid hormone (ng/L)

Secondary Outcome Measures

Name	Time	Method
Calcium	1 day	serum calcium level (mg/dl)
Magnesium	1 day	serum magnesium level (meq/L)
Phosphorus	1 day	serum phosphorus level (mg/dl)
Albumin	1 day	serum albumin level (g/dl)

Trial Locations

Locations (1)

Ain Shams Maternity Hospital; 🇪🇬 Cairo, Egypt