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CompletedNCT05688007Updated Jan 18, 2023

The Association Between Parathyroid Hormone and Preterm Labor

An observational study in Preterm Labor and Parathyroid Diseases, sponsored by Ain Shams Maternity Hospital. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-01-18.

Sponsored by Ain Shams Maternity Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 40 Years
Sex
Female
01

Study 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?

Read the 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    • Venous blood samples will be withdrawn about (3ml) once from every patient within one hour from inclusion into the study to measure serum parathyroid hormone, calcium, magnesium, phosphorus and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.
02

Conditions studied

  • Preterm Labor
  • Parathyroid Diseases

Keywords

  • parathyroid hormone; calcium, magnesium, phosphorus, albumin
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 100 is below the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Ain Shams Maternity Hospital is the lead sponsor of 135 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Pregnant women aged (18-40).
  • Gestational age (28-36 weeks).

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 · Diagnostic Test: serum electrolytes

  • Controls

    pregnant women not in labor - gestational age: (28- 36 weeks)

    Diagnostic Test: parathyroid hormone level · Diagnostic Test: serum electrolytes

Interventions

  • Diagnostic testparathyroid hormone level

    Serum level of parathyroid hormone

  • Diagnostic testserum electrolytes

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

06

What researchers measure

Primary outcomes

  1. parathyroid hormone

    serum level of parathyroid hormone (ng/L)

    Time frame: 1 day

Secondary outcomes

  1. Calcium

    serum calcium level (mg/dl)

    Time frame: 1 day

  2. Magnesium

    serum magnesium level (meq/L)

    Time frame: 1 day

  3. Phosphorus

    serum phosphorus level (mg/dl)

    Time frame: 1 day

  4. Albumin

    serum albumin level (g/dl)

    Time frame: 1 day

07

Study locations

1 site
  • Ain Shams Maternity Hospital
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — protocol and dataset (analytic code) can be sent via email upon reasonable requests

Supporting information: Study protocol, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05688007
Lead sponsor
Ain Shams Maternity Hospital
Responsible party
Rania Hassan Mostafa (Principal Investigator, Ain Shams Maternity Hospital) — Principal investigator
First posted
Jan 18, 2023
Start date
Apr 1, 2021
Primary completion
Oct 16, 2022
Completion
Dec 30, 2022
Last update
Jan 18, 2023

Study contacts

Sherif A Ashoush, MD
study director · Faculty of Medicine Ain Shams University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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