Progesterone Levels and Pregnancy Results

The Effect of Maternal Serum and Amniotic Fluid Progesterone Levels on Pregnancy Results

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Complications; Pregnancy Loss; Pregnancy Preterm
• Intervention / Treatment: Diagnostic test: amniocentesis

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: tufan arslanca, M.D.; Phone Number: +905324580546; Email: drtufanarslanca@hotmail.com
• Study Contact Backup: Name: banu arslanca, M.D.; Phone Number: +90 532 253 80 13; Email: dr.banubozkurt@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ufuk University

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

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Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): June 20, 2022
• Study Completion (Anticipated): November 20, 2022

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 31, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications
• Other Study ID Numbers: amniotic fluid progesteron

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No