Progesterone Levels and Pregnancy Results

• Conditions: Pregnancy Complications; Pregnancy Loss; Pregnancy Preterm
• Interventions: Diagnostic Test: amniocentesis

• Registration Number: NCT04400149
• Lead Sponsor: Ufuk University

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-22
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-31
• Last Update Posted: 2021-11-02
• Study Start: 2021-12-01
• Primary Completion: 2022-06-20
• Study Completion: 2022-11-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
pregnancy outcome	starting from 16 weeks, ending at the delivery of the baby	gestational diabetes

Secondary Outcome Measures

Name	Time	Method
fetal outcomes	starting from 16 weeks, ending at the delivery of the baby	fetal gender