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?

Study Overview

• Status: Completed
• Conditions: Parathyroid Diseases; Preterm Labor
• Intervention / Treatment: Diagnostic test: parathyroid hormone level; Diagnostic test: serum electrolytes

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   • Venous blood samples will be withdrawn about (3ml) once from every patient within one hour from inclusion into the study to measure serum parathyroid hormone, calcium, magnesium, phosphorus and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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women attending Ain Shams University Maternity Hospital (labor ward and antenatal outpatient clinic)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; 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).	Diagnostic test: parathyroid hormone level; Serum level of parathyroid hormone; Diagnostic test: serum electrolytes; Serum levels of: magnesium, phosphorus, calcium, and albumin
Controls; pregnant women not in labor - gestational age: (28- 36 weeks)	Diagnostic test: parathyroid hormone level; Serum level of parathyroid hormone; Diagnostic test: serum electrolytes; Serum levels of: magnesium, phosphorus, calcium, and albumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
parathyroid hormone	serum level of parathyroid hormone (ng/L)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calcium	serum calcium level (mg/dl)	1 day
Magnesium	serum magnesium level (meq/L)	1 day
Phosphorus	serum phosphorus level (mg/dl)	1 day
Albumin	serum albumin level (g/dl)	1 day

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Study Director: Sherif A Ashoush, MD, Faculty of Medicine Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): October 16, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: parathyroid hormone; calcium, magnesium, phosphorus, albumin
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature; Parathyroid Diseases; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Calcium-Regulating Hormones and Agents; Hormones; Parathyroid Hormone
• Other Study ID Numbers: MS 168/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: protocol and dataset (analytic code) can be sent via email upon reasonable requests
• IPD Sharing Time Frame: after publication of the manuscript, and for one year after.
• IPD Sharing Access Criteria: via email (raneyah@gmail.com)
• IPD Sharing Supporting Information Type: Study Protocol; Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No