Progesterone Levels and Pregnancy Results

Overview

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

Full Title of Study: “The Effect of Maternal Serum and Amniotic Fluid Progesterone Levels on Pregnancy Results”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 20, 2020

Detailed 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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 1
    • amniotic fluid progesterone (this group will be evaluated by the amniotic fluid which was received via amniocentesis). This group consisted of pregnant women who had high risk in the antenal test and give consent to perform amniocentesis. Notwithstanding, amniocentesis detects chromosome abnormalities, neural tube defects, and genetic disorders for the fetuses. İn a routine amniocentesis, 1-2 ml amniotic fluid which was taken in the first place was discarded in order to prevent maternal contamination. Then 15-20 ml amniotic fluid was taken from all of the patients to diagnose genetic disorders of the fetuses. İn this study we evaluate the amniotic fluid progesterone in this 1-2 ml amniotic fluid which was discarded and throw away. Therefore, we are not performing an extra invasive procedure for pregnant women
  • 2
    • serum progesterone (this group consisted of the pregnant women who have amniocentesis procedure and blood samples were taken in the same procedure )

Clinical Trial Outcome Measures

Primary Measures

  • pregnancy outcome
    • Time Frame: starting from 16 weeks, ending at the delivery of the baby
    • premature membran rupture Web sonuçları Premature Rupture of Membranes
  • pregnancy outcome
    • Time Frame: starting from 16 weeks, ending at the delivery of the baby
    • pregnancy loss
  • pregnancy outcome
    • Time Frame: starting from 16 weeks, ending at the delivery of the baby
    • preeclampsia
  • pregnancy outcome
    • Time Frame: starting from 16 weeks, ending at the delivery of the baby
    • gestational diabetes

Secondary Measures

  • fetal outcomes
    • Time Frame: starting from 16 weeks, ending at the delivery of the baby
    • low birth weight
  • fetal outcomes
    • Time Frame: starting from 16 weeks, ending at the delivery of the baby
    • preterm labor
  • fetal outcomes
    • Time Frame: starting from 16 weeks, ending at the delivery of the baby
    • fetal gender

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ufuk University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tufan Arslanca, M.D. – Ufuk University
  • Overall Contact(s)
    • tufan arslanca, M.D., +905324580546, drtufanarslanca@hotmail.com

Citations Reporting on Results

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.

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):605-11.

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