Progesterone Levels and Pregnancy Results

Sponsor

Ufuk University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04400149

Collaborator

(none)

100

Enrollment

11.6

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Complications Pregnancy Preterm Pregnancy Loss	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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Jun 20, 2022

Anticipated Study Completion Date :

Nov 20, 2022

Arms and Interventions

Arm	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.

Arm

Intervention/Treatment

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.

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

fetal outcomes [starting from 16 weeks, ending at the delivery of the baby]
low birth weight
fetal outcomes [starting from 16 weeks, ending at the delivery of the baby]
preterm labor
fetal outcomes [starting from 16 weeks, ending at the delivery of the baby]
fetal gender

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ufuk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Tufan Arslanca, M.D., Ufuk University

ClinicalTrials.gov Identifier:

NCT04400149

Other Study ID Numbers:

amniotic fluid progesteron

First Posted:

May 22, 2020

Last Update Posted:

Nov 2, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pregnancy Complications

Study Results

No Results Posted as of Nov 2, 2021