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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04400149
Other study ID # amniotic fluid progesteron
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date November 20, 2022

Study information

Verified date October 2021
Source Ufuk University
Contact tufan arslanca, M.D.
Phone +905324580546
Email drtufanarslanca@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate the amniotic fluid and serum progesterone level and pregnancy outcome


Description:

Studies have investigated the relationship between maternal serum progesterone level and low birth weight baby birth, hypertensive disorders of pregnancy, and early pregnancy bleeding. In some cases, patients are supported by oral or vaginal progesterone treatments during pregnancy. We also measure the relationship between maternal serum progesterone by measuring the level of amnion progesterone; We aimed to analyze the effects on pregnancy outcomes by observing preterm birth, premature rupture of membranes, low birth weight, baby gender, maternal problems that may occur during pregnancy, fetal problems.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date November 20, 2022
Est. primary completion date June 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Singleton pregnancy - Women who did not receive progesterone treatment during pregnancy Exclusion Criteria: - Women who receive progesterone treatment during pregnancy - multiple pregnancies - Diagnosed hypertension, diabetes mellitus, kidney disease, heart disease, liver disease

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
amniocentesis
amniocentesis will be performed to the pregnant women at 16-20 weeks who had a high-risk antenatal test. Furthermore, these women also give a blood sample (at 16-20 weeks) to compare the amniotic fluid and serum progesterone levels in association with pregnancy outcomes. We perform amniocentesis to evaluate genetic disorders in pregnant women who had his risk in the antenal test.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ufuk University

References & Publications (2)

Johansson ED, Jonasson LE. Progesterone levels in amniotic fluid and plasma from women. I. Levels during normal pregnancy. Acta Obstet Gynecol Scand. 1971;50(4):339-43. — View Citation

Lau IF, Saksena SK, Salmonsen R. The concentration of progesterone, 20 alpha-dihydroprogesterone, testosterone, oestrone and oestradiol-17 beta in serum, amniotic fluid and placental tissue of pregnant rabbits. Acta Endocrinol (Copenh). 1982 Apr;99(4):605 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary pregnancy outcome premature membran rupture Web sonuçlari
Premature Rupture of Membranes
starting from 16 weeks, ending at the delivery of the baby
Primary pregnancy outcome pregnancy loss starting from 16 weeks, ending at the delivery of the baby
Primary pregnancy outcome preeclampsia starting from 16 weeks, ending at the delivery of the baby
Primary pregnancy outcome gestational diabetes starting from 16 weeks, ending at the delivery of the baby
Secondary fetal outcomes low birth weight starting from 16 weeks, ending at the delivery of the baby
Secondary fetal outcomes preterm labor starting from 16 weeks, ending at the delivery of the baby
Secondary fetal outcomes fetal gender starting from 16 weeks, ending at the delivery of the baby
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