Umbilical Artery Embolism,Single Umbilical Artery,Pregnancy OutcomeNCT05327036
The Effect of Single Umbilical Artery Caused by Umbilical Artery Embolism on Pregnancy Outcome
An observational study of Umbilical Artery Embolism,Single Umbilical Artery,Pregnancy Outcome, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
To investigate the relationship between single umbilical artery caused by umbilical artery embolism and pregnancy outcome , and to provide evidence-based evidence for peripartum health care of pregnant women with umbilical artery embolism. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Umbilical Artery Embolism,Single Umbilical Artery,Pregnancy Outcome
- What is being tested?
- collect information about all participants
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2024
- 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 34 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The participants include women with pregnancy meeting the inclusion criteria
Who may be able to join
- Age 18 ~ 34years old
- B-ultrasound first showed double umbilical artery, then single umbilical artery or pregnant women with umbilical artery embolism supported by intrapartum and postpartum pathology.
- B-ultrasound of prenatal examination showed a single umbilical artery, and prenatal and postpartum pathology showed pregnant women with a single umbilical artery.
Who cannot join
- The fetus has extracardiac malformation and aneuploid deformity
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
Ying Hua, Doctor, 13676403165, wzfeyhy1015@126.com
About this study
To investigate the relationship between single umbilical artery caused by umbilical artery embolism and pregnancy outcome , and to provide evidence-based evidence for peripartum health care of pregnant women with umbilical artery embolism.
- Being tested
- collect information about all participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collect information about all participantsOther
collect information On age,pregnancy history,Height, weight,Gestational weeks of umbilical artery embolism,Gestational week of delivery, mode of delivery, newborn birth weight, birth height, Apgar score, umbilical cord length, umbilical cord placental insertion point, placental weight, pregnancy complications, coagulation function,after obtaining the consent of all participants.
| Study group | Role | What they receive |
|---|---|---|
| pregnant women with Single Umbilical Artery | pregnant women with Single Umbilical Artery Receives: Other: collect information about all participants | |
| pregnant women with Umbilical Artery Embolism | pregnant women with Umbilical Artery Embolism Receives: Other: collect information about all participants | |
| Normal pregnant women | Normal pregnant women without pregnancy complications Receives: Other: collect information about all participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational week of delivery
The gestational age of delivery is determined according to the last menstruation and ultrasonic diagnosis.
Measured: 32 weeks to 40 weeks gestation
mode of delivery
The mode of delivery including vaginal delivery and cesarean section, is determined by the exact condition of pregnancy.
Measured: 32 weeks to 40 weeks gestation
newborn birth weight
Newborn weight is measured immediately after birth.
Measured: 32 weeks to 40 weeks gestation
birth height
Birth height is measured immediately after birth.
Measured: 32 weeks to 40 weeks gestation
Apgar score
Apgar score is assessed at 1 min and 5 minute after birth.
Measured: 32 weeks to 40 weeks gestation
Secondary outcomes (4)
coagulation function
Coagulation function including prothrombin time and activated partial thromboplastin time is measured just before delivery.
Measured: 32 weeks to 40 weeks gestation
placental weight
Placental weight is measured after delivery of the placenta.
Measured: 32 weeks to 40 weeks gestation
umbilical cord placental insertion point
The placenta is observed after delivery to determine the insertion point of the umbilical cord in placenta.
Measured: 32 weeks to 40 weeks gestation
umbilical cord length
Umbilical cord length is measured after delivery of the neonate.
Measured: 32 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 posted14 Apr 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical Artery Embolism,Single Umbilical Artery,Pregnancy OutcomeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
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
- NCT05327036
- Sponsor's protocol ID
- SAHoWMU-CR2022-07-202
- Status last verified
- Mar 2022
- First submitted
- 30 Mar 2022
- Last updated
- 14 Apr 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 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Single Umbilical Artery Caused by Umbilical Artery Embolism on Pregnancy Outcome
- ClinicalTrials.gov ID
- NCT05327036
- Acronym / sponsor ID
- SAHoWMU-CR2022-07-202
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Apr 2022 (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.
To investigate the relationship between single umbilical artery caused by umbilical artery embolism and pregnancy outcome , and to provide evidence-based evidence for peripartum health care of pregnant women with umbilical artery embolism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pregnant women with Single Umbilical Artery | – | Other: collect information about all participantspregnant women with Single Umbilical Artery |
| pregnant women with Umbilical Artery Embolism | – | Other: collect information about all participantspregnant women with Umbilical Artery Embolism |
| Normal pregnant women | – | Other: collect information about all participantsNormal pregnant women without pregnancy complications |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participants include women with pregnancy meeting the inclusion criteria
Key inclusion criteria (3 listed)
- Age 18 ~ 34years old
- B-ultrasound first showed double umbilical artery, then single umbilical artery or pregnant women with umbilical artery embolism supported by intrapartum and postpartum pathology.
- B-ultrasound of prenatal examination showed a single umbilical artery, and prenatal and postpartum pathology showed pregnant women with a single umbilical artery.
Key exclusion criteria (1 listed)
- The fetus has extracardiac malformation and aneuploid deformity
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 |
|---|---|---|
| collect information about all participantscollect information On age,pregnancy history,Height, weight,Gestational weeks of umbilical artery embolism,Gestational week of delivery, mode of delivery, newborn birth weight, birth height, Apgar score, umbilical cord length, umbilical cord placental insertion point, placental weight, pregnancy complications, coagulation function,after obtaining the consent of all participants. | Other | Normal pregnant women, pregnant women with Single Umbilical Artery, pregnant women with Umbilical Artery Embolism |
Primary outcome
Gestational week of delivery
Time frame: 32 weeks to 40 weeks gestation
The gestational age of delivery is determined according to the last menstruation and ultrasonic diagnosis.
mode of delivery
Time frame: 32 weeks to 40 weeks gestation
The mode of delivery including vaginal delivery and cesarean section, is determined by the exact condition of pregnancy.
newborn birth weight
Time frame: 32 weeks to 40 weeks gestation
Newborn weight is measured immediately after birth.
birth height
Time frame: 32 weeks to 40 weeks gestation
Birth height is measured immediately after birth.
Apgar score
Time frame: 32 weeks to 40 weeks gestation
Apgar score is assessed at 1 min and 5 minute after birth.
4 secondary outcomes
coagulation function
Time frame: 32 weeks to 40 weeks gestation
placental weight
Time frame: 32 weeks to 40 weeks gestation
umbilical cord placental insertion point
Time frame: 32 weeks to 40 weeks gestation
umbilical cord length
Time frame: 32 weeks to 40 weeks gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
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 Umbilical Artery Embolism,Single Umbilical Artery,Pregnancy Outcome, 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 3 inclusion and 1 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 14 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Hua (+8613676403165 ext. +8613676403165, wzfeyhy1015@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational week of delivery (time frame: 32 weeks to 40 weeks gestation). The study lists 5 primary outcomes in all. 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 14 Apr 2022.