Phthalate ExposureNCT04777929
The Relationship of Phthalate Exposure During Pregnancy and Preeclampsia
An observational study of Phthalate Exposure and Preeclampsia, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Phthalates are a group of ubiquitous synthetic endocrine-disrupting chemicals. Fetal and neonatal periods are particularly susceptible to endocrine disorders, which prenatal exposure to phthalates causes. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Phthalate Exposure, Preeclampsia, Estrogen
- What is being tested?
- test Phthalates, estrogen and progesterone
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Oct 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The participants include pregnant women meeting the inclusion criteria.
Who may be able to join
- Singleton pregnancy
- Term pregnancy with the gestational age of 37-40 weeks
Who cannot join
- Maternal systemic diseases (hypertension disorders, immunological diseases) or pregnant complications (polyhydramnios, oligohydramnios, diabetes mellitus, intrahepatic cholestasis of pregnancy)
- Delivery before 37 weeks or after 40 weeks
Trial locations and contacts
1 site in 1 country.
China1 site
department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
About this study
Phthalates are a group of ubiquitous synthetic endocrine-disrupting chemicals. Fetal and neonatal periods are particularly susceptible to endocrine disorders, which prenatal exposure to phthalates causes. There is increasing evidence concerning the potential endocrine disrupting for phthalate exposure during pregnancy. Prenatal exposure phthalates would disrupt the level of sex hormone in pregnant women, which results in preeclampsia. The relationship of prenatal phthalate exposure with maternal and neonatal outcomes in human beings was often sex-specific associations. Because of the potentially harmful influence of prenatal phthalate exposure, steps should be taken to prevent or reduce phthalate exposure during pregnancy.
- Conditions
- Phthalate Exposure, Preeclampsia, Estrogen, Progestin
- Being tested
- test Phthalates, estrogen and progesterone
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test Phthalates, estrogen and progesteroneOther
test mothers Phthalates in their urine, and test estrogen and progesterone receptor in placental tissue
| Study group | Role | What they receive |
|---|---|---|
| healthy pregnant woman | pregnant woman without any disease of pregnancy Receives: Other: test Phthalates, estrogen and progesterone | |
| pregnant woman with preeclampia | pregnant woman with preeclampia but without any other disease of pregnancy Receives: Other: test Phthalates, estrogen and progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phthalates in urine
Collect the urine of pregnant women and test the abundance of Phthalates
Measured: 37 weeks to 40 weeks gestation
Secondary outcomes (1)
The female progesterone
Collect the placenta tissue of pregnant women and test the abundance of estrogen progesterone receptor
Measured: 37 weeks to 40 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Jan 2021
- Primary completion30 Sep 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phthalate ExposureStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Hua, Study director, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777929
- Sponsor's protocol ID
- SAHoWMU-CR2020-07-210
- Status last verified
- Nov 2022
- First submitted
- 28 Feb 2021
- Last updated
- 29 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Phthalate Exposure During Pregnancy and Preeclampsia
- ClinicalTrials.gov ID
- NCT04777929
- Acronym / sponsor ID
- SAHoWMU-CR2020-07-210
- Conditions
- Phthalate Exposure, Preeclampsia, Estrogen, Progestin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 2 Mar 2021 (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.
Phthalates are a group of ubiquitous synthetic endocrine-disrupting chemicals. Fetal and neonatal periods are particularly susceptible to endocrine disorders, which prenatal exposure to phthalates causes. There is increasing evidence concerning the potential endocrine disrupting for phthalate exposure during pregnancy. Prenatal exposure phthalates would disrupt the level of sex hormone in pregnant women, which results in preeclampsia. The relationship of prenatal phthalate exposure with maternal and neonatal outcomes in human beings was often sex-specific associations. Because of the potentially harmful influence of prenatal phthalate exposure, steps should be taken to prevent or reduce phthalate exposure during pregnancy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy pregnant woman | – | Other: test Phthalates, estrogen and progesteronepregnant woman without any disease of pregnancy |
| pregnant woman with preeclampia | – | Other: test Phthalates, estrogen and progesteronepregnant woman with preeclampia but without any other disease of pregnancy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participants include pregnant women meeting the inclusion criteria.
Key inclusion criteria (2 listed)
- Singleton pregnancy
- Term pregnancy with the gestational age of 37-40 weeks
Key exclusion criteria (2 listed)
- Maternal systemic diseases (hypertension disorders, immunological diseases) or pregnant complications (polyhydramnios, oligohydramnios, diabetes mellitus, intrahepatic cholestasis of pregnancy)
- Delivery before 37 weeks or after 40 weeks
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 |
|---|---|---|
| test Phthalates, estrogen and progesteronetest mothers Phthalates in their urine, and test estrogen and progesterone receptor in placental tissue | Other | healthy pregnant woman, pregnant woman with preeclampia |
Primary outcome
Phthalates in urine
Time frame: 37 weeks to 40 weeks gestation
Collect the urine of pregnant women and test the abundance of Phthalates
1 secondary outcome
The female progesterone
Time frame: 37 weeks to 40 weeks gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
Related trials for Phthalate Exposure
Active, not recruiting
Weight Loss and Endocrine Disrupting Chemicals (EDCs): Lifestyle Interventions to Lose Weight and Reduce EDC Exposure in Individuals With Overweight/Obesity
Obesity &Amp;Amp;Amp; Overweight, Environmental Exposure
Not yet recruiting
Reducing Endocrine-Disrupting Chemical Exposure in Reproductive-Age Women: A Pender Model-Based RCT
Women Who Are Aged 18-49 Years, Able to Read, Write
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.
Ying Hua study director
Second Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phthalate Exposure and Preeclampsia, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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 2 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: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phthalates in urine (time frame: 37 weeks to 40 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2022.