Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05688007
Status:
COMPLETED
Last Update Posted:
2023-01-18
First Post:
2023-01-09
Brief Title:
The Association Between Parathyroid Hormone and Preterm Labor
Sponsor:
Ain Shams Maternity Hospital
Organization:
Ain Shams Maternity Hospital
Study Overview
Official Title:
The Association Between Parathyroid Hormone and Preterm Labor
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Naegeles 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Venous blood samples will be withdrawn about 3ml once from every patient within one hour from inclusion into the study to measure serum parathyroid hormone calcium magnesium phosphorus and albumin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
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 Naegeles 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None