NCT05688007

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

1.5 years

First QC Date

January 9, 2023

Last Update Submit

January 17, 2023

Conditions

Preterm LaborParathyroid Diseases

Keywords

parathyroid hormone; calcium, magnesium, phosphorus, albumin

Outcome Measures

Primary Outcomes (1)

  • parathyroid hormone

    serum level of parathyroid hormone (ng/L)

    1 day

Secondary Outcomes (4)

  • Calcium

    1 day

  • Magnesium

    1 day

  • Phosphorus

    1 day

  • Albumin

    1 day

Study Arms (2)

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 levelDiagnostic Test: serum electrolytes

Controls

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

Diagnostic Test: parathyroid hormone levelDiagnostic Test: serum electrolytes

Interventions

parathyroid hormone levelDIAGNOSTIC_TEST

Serum level of parathyroid hormone

CasesControls
serum electrolytesDIAGNOSTIC_TEST

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

CasesControls

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Obstetric Labor, PrematureParathyroid Diseases

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesEndocrine System Diseases

Study Officials

  • Sherif A Ashoush, MD

    Faculty of Medicine Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 18, 2023

Study Start

April 1, 2021

Primary Completion

October 16, 2022

Study Completion

December 30, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

protocol and dataset (analytic code) can be sent via email upon reasonable requests

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
after publication of the manuscript, and for one year after.
Access Criteria
via email (raneyah@gmail.com)

Locations

EG(1)