Preterm LaborNCT05688007
The Association Between Parathyroid Hormone and Preterm Labor
An observational study of Preterm Labor and Parathyroid Diseases, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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? Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preterm Labor, Parathyroid Diseases
- What is being tested?
- parathyroid hormone level and serum electrolytes
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women attending Ain Shams University Maternity Hospital (labor ward and antenatal outpatient clinic)
Who may be able to join
- Pregnant women aged (18-40).
- Gestational age (28-36 weeks).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
- Cases: established preterm labor - gestational age: (28-36 weeks)
- 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.
- Conditions
- Preterm Labor, Parathyroid Diseases
- Being tested
- parathyroid hormone level, serum electrolytes
- Keywords
- parathyroid hormone; calcium, magnesium, phosphorus, albumin
- Medical subject headings
- Obstetric Labor, Premature, Parathyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parathyroid hormone levelDiagnostic test
Serum level of parathyroid hormone
serum electrolytesDiagnostic test
Serum levels of: magnesium, phosphorus, calcium, and albumin
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: parathyroid hormone level; Diagnostic Test: serum electrolytes | |
| Controls | pregnant women not in labor - gestational age: (28- 36 weeks) Receives: Diagnostic Test: parathyroid hormone level; Diagnostic Test: serum electrolytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
parathyroid hormone
serum level of parathyroid hormone (ng/L)
Measured: 1 day
Secondary outcomes (4)
Calcium
serum calcium level (mg/dl)
Measured: 1 day
Magnesium
serum magnesium level (meq/L)
Measured: 1 day
Phosphorus
serum phosphorus level (mg/dl)
Measured: 1 day
Albumin
serum albumin level (g/dl)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Apr 2021
- Primary completion16 Oct 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Hassan Mostafa, Ain Shams Maternity Hospital
- Investigators
- Sherif A Ashoush, MD, Study director, Faculty of Medicine Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688007
- Sponsor's protocol ID
- MS 168/2021
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: protocol and dataset (analytic code) can be sent via email upon reasonable requests
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Parathyroid Hormone and Preterm Labor
- ClinicalTrials.gov ID
- NCT05688007
- Acronym / sponsor ID
- MS 168/2021
- Conditions
- Preterm Labor, Parathyroid Diseases
- Keywords
- parathyroid hormone; calcium, magnesium, phosphorus, albumin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 16 Oct 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Cases: established preterm labor - gestational age: (28-36 weeks)
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: parathyroid hormone level, Diagnostic Test: serum electrolytespregnant 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 | – | Diagnostic Test: parathyroid hormone level, Diagnostic Test: serum electrolytespregnant women not in labor - gestational age: (28- 36 weeks) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women attending Ain Shams University Maternity Hospital (labor ward and antenatal outpatient clinic)
Key inclusion criteria (2 listed)
- Pregnant women aged (18-40).
- Gestational age (28-36 weeks).
Key exclusion criteria (8 listed)
- Known maternal disease as diabetes, hypertension, renal disease, cardiac disease and liver disease.
- Known hypo or hyperparathyroidism
- Multiple pregnancy
- Polyhydramnios
- Premature rupture of membrane
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| parathyroid hormone levelSerum level of parathyroid hormone | Diagnostic test | Cases, Controls |
| serum electrolytesSerum levels of: magnesium, phosphorus, calcium, and albumin | Diagnostic test | Cases, Controls |
Primary outcome
parathyroid hormone
Time frame: 1 day
serum level of parathyroid hormone (ng/L)
4 secondary outcomes
Calcium
Time frame: 1 day
Magnesium
Time frame: 1 day
Phosphorus
Time frame: 1 day
Albumin
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: Yes. protocol and dataset (analytic code) can be sent via email upon reasonable requests
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherif A Ashoush, MD study director
Faculty of Medicine Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labor and Parathyroid Diseases, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parathyroid hormone (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.