Progesterone Levels and Pregnancy Results

NCT04400149 | Unknown

• 1 other identifier: amniotic fluid progesteron
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pregnancy Complications; Pregnancy Preterm; Pregnancy Loss

Outcome Measures

Primary Outcomes (4)

• pregnancy outcome

  premature membran rupture Web sonuçları Premature Rupture of Membranes

  starting from 16 weeks, ending at the delivery of the baby

• pregnancy outcome

  pregnancy loss

  starting from 16 weeks, ending at the delivery of the baby

• pregnancy outcome

  preeclampsia

  starting from 16 weeks, ending at the delivery of the baby

• pregnancy outcome

  gestational diabetes

  starting from 16 weeks, ending at the delivery of the baby

Secondary Outcomes (3)

• fetal outcomes

  starting from 16 weeks, ending at the delivery of the baby

• fetal outcomes

  starting from 16 weeks, ending at the delivery of the baby

• fetal outcomes

  starting from 16 weeks, ending at the delivery of the baby

Study Arms (2)

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

Diagnostic Test: amniocentesis

2

serum progesterone (this group consisted of the pregnant women who have amniocentesis procedure and blood samples were taken in the same procedure )

Diagnostic Test: amniocentesis

Interventions

amniocentesis DIAGNOSTIC_TEST

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.

1; 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population consists of 18-45 years old pregnant women who had a high risk in the antenatal screening test and give consent to perform amniocentesis.

You may qualify if:

• Singleton pregnancy
• Women who did not receive progesterone treatment during pregnancy

You may not qualify if:

• Women who receive progesterone treatment during pregnancy
• multiple pregnancies
• Diagnosed hypertension, diabetes mellitus, kidney disease, heart disease, liver disease

Sponsors & Collaborators

• Ufuk University: lead

Related 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. doi: 10.3109/00016347109157335. No abstract available.

  PMID: 5157500 RESULT

• 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. doi: 10.1530/acta.0.0990605.

  PMID: 7072456 RESULT

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Amniocentesis

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Paracentesis; Specimen Handling; Prenatal Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

tufan arslanca, M.D.

CONTACT

+905324580546; drtufanarslanca@hotmail.com

banu arslanca, M.D.

CONTACT

+90 532 253 80 13; dr.banubozkurt@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: December 1, 2021
• Primary Completion: June 20, 2022
• Study Completion: November 20, 2022
• Last Updated: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share