Pregnancy ComplicationsNCT04400149
Progesterone Levels and Pregnancy Results
An observational study of Pregnancy Complications and Pregnancy Preterm, run by Ufuk University.
Trial summary
The aim of this study is to evaluate the amniotic fluid and serum progesterone level and pregnancy outcome Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications, Pregnancy Preterm, Pregnancy Loss
- What is being tested?
- amniocentesis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 20 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Singleton pregnancy
- Women who did not receive progesterone treatment during pregnancy
Who cannot join
- Women who receive progesterone treatment during pregnancy
- multiple pregnancies
- Diagnosed hypertension, diabetes mellitus, kidney disease, heart disease, liver disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Conditions
- Pregnancy Complications, Pregnancy Preterm, Pregnancy Loss
- Being tested
- amniocentesis
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amniocentesisDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 ) Receives: Diagnostic Test: amniocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy outcome
premature membran rupture Web sonuçları
Premature Rupture of Membranes
Measured: starting from 16 weeks, ending at the delivery of the baby
pregnancy outcome
pregnancy loss
Measured: starting from 16 weeks, ending at the delivery of the baby
pregnancy outcome
preeclampsia
Measured: starting from 16 weeks, ending at the delivery of the baby
pregnancy outcome
gestational diabetes
Measured: starting from 16 weeks, ending at the delivery of the baby
Secondary outcomes (3)
fetal outcomes
low birth weight
Measured: starting from 16 weeks, ending at the delivery of the baby
fetal outcomes
preterm labor
Measured: starting from 16 weeks, ending at the delivery of the baby
fetal outcomes
fetal gender
Measured: starting from 16 weeks, ending at the delivery of the baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 Dec 2021 (estimated)
- Primary completion20 Jun 2022 (estimated)
- Study completion20 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tufan Arslanca, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400149
- Sponsor's protocol ID
- amniotic fluid progesteron
- Status last verified
- Oct 2021
- First submitted
- 19 May 2020
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 5157500Lau 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.
PubMed 7072456
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Maternal Serum and Amniotic Fluid Progesterone Levels on Pregnancy Results
- ClinicalTrials.gov ID
- NCT04400149
- Acronym / sponsor ID
- amniotic fluid progesteron
- Conditions
- Pregnancy Complications, Pregnancy Preterm, Pregnancy Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 20 Jun 2022 (estimated)
- Study completion
- 20 Nov 2022 (estimated)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: amniocentesisamniotic 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 | – | Diagnostic Test: amniocentesisserum progesterone (this group consisted of the pregnant women who have amniocentesis procedure and blood samples were taken in the same procedure ) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Singleton pregnancy
- Women who did not receive progesterone treatment during pregnancy
Key exclusion criteria (3 listed)
- Women who receive progesterone treatment during pregnancy
- multiple pregnancies
- Diagnosed hypertension, diabetes mellitus, kidney disease, heart disease, liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amniocentesisamniocentesis 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. | Diagnostic test | 1, 2 |
Primary outcome
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
3 secondary outcomes
fetal outcomes
Time frame: starting from 16 weeks, ending at the delivery of the baby
fetal outcomes
Time frame: starting from 16 weeks, ending at the delivery of the baby
fetal outcomes
Time frame: starting from 16 weeks, ending at the delivery of the baby
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Results publication: PubMed 5157500Johansson 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.
- Results publication: PubMed 7072456Lau 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complications and Pregnancy Preterm, run by Ufuk University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact tufan arslanca, M.D. (+905324580546, drtufanarslanca@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy outcome (time frame: starting from 16 weeks, ending at the delivery of the baby). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04400149, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.