The Effect of Single Umbilical Artery Caused by Umbilical Artery Embolism on Pregnancy Outcome

April 12, 2022 updated by: Second Affiliated Hospital of Wenzhou Medical University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Recruiting
        • department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 34 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The participants include women with pregnancy meeting the inclusion criteria

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • The fetus has extracardiac malformation and aneuploid deformity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pregnant women with Single Umbilical Artery
Other: collect information about all participants
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.
pregnant women with Umbilical Artery Embolism
Other: collect information about all participants
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.
Normal pregnant women
Normal pregnant women without pregnancy complications
Other: collect information about all participants
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
32 weeks to 40 weeks gestation
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.
32 weeks to 40 weeks gestation
newborn birth weight
Time Frame: 32 weeks to 40 weeks gestation
Newborn weight is measured immediately after birth.
32 weeks to 40 weeks gestation
birth height
Time Frame: 32 weeks to 40 weeks gestation
Birth height is measured immediately after birth.
32 weeks to 40 weeks gestation
Apgar score
Time Frame: 32 weeks to 40 weeks gestation
Apgar score is assessed at 1 min and 5 minute after birth.
32 weeks to 40 weeks gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
coagulation function
Time Frame: 32 weeks to 40 weeks gestation
Coagulation function including prothrombin time and activated partial thromboplastin time is measured just before delivery.
32 weeks to 40 weeks gestation
placental weight
Time Frame: 32 weeks to 40 weeks gestation
Placental weight is measured after delivery of the placenta.
32 weeks to 40 weeks gestation
umbilical cord placental insertion point
Time Frame: 32 weeks to 40 weeks gestation
The placenta is observed after delivery to determine the insertion point of the umbilical cord in placenta.
32 weeks to 40 weeks gestation
umbilical cord length
Time Frame: 32 weeks to 40 weeks gestation
Umbilical cord length is measured after delivery of the neonate.
32 weeks to 40 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

March 30, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2022-07-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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