The Association Between Parathyroid Hormone and Preterm Labor

Preterm Labor Clinical Trial

Official title:

The Association Between Parathyroid Hormone and Preterm Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05688007
• Other study ID #: MS 168/2021
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2023
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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• Venous blood samples will be withdrawn about (3ml) once from every patient within one hour from inclusion into the study to measure serum parathyroid hormone, calcium, magnesium, phosphorus and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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 30, 2022
• Est. primary completion date: October 16, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Parathyroid Diseases
• Premature Birth
• Preterm Labor

Intervention

Diagnostic Test:
• parathyroid hormone level
Serum level of parathyroid hormone
• serum electrolytes
Serum levels of: magnesium, phosphorus, calcium, and albumin

Locations

Country	Name	City	State
Egypt	Ain Shams Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	parathyroid hormone	serum level of parathyroid hormone (ng/L)	1 day
Secondary	Calcium	serum calcium level (mg/dl)	1 day
Secondary	Magnesium	serum magnesium level (meq/L)	1 day
Secondary	Phosphorus	serum phosphorus level (mg/dl)	1 day
Secondary	Albumin	serum albumin level (g/dl)	1 day