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The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Preterm Birth

Primary Purpose

Ductus Arteriosus

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ultrasound examination
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ductus Arteriosus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

Inclusion criteria:

  • Low risk singleton pregnancy at 32 weeks gestation.

Exclusion criteria:

  • Smoking
  • Underlying cardiac or respiratory illness
  • Fetal growth restriction
  • Medicated gestational hypertension or evolving preeclampsia
  • Gestational diabetes controlled with insulin or oral medications
  • Use of steroids for lung maturation in the current pregnancy
  • Known major congenital anomalies.

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ultrasound examination

Arm Description

Participants will undergo an ultrasound examination at 32 weeks gestation.

Outcomes

Primary Outcome Measures

Fetal ductus arteriosus changes
To prospectively assess any changes in blood flow in the fetal ductus arteriosus at 32 weeks' gestation.

Secondary Outcome Measures

Time to delivery
To investigate whether there is an association between the ductus arteriosus parameters and the time to delivery interval at 32 weeks' gestation.

Full Information

First Posted
February 15, 2017
Last Updated
February 20, 2019
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03073512
Brief Title
The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Preterm Birth
Official Title
The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Preterm Birth
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to locate the resources necessary to complete participant recruitment.
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Preterm birth still remains a major cause of perinatal morbidity and mortality worldwide. The exact mechanism stimulating term and preterm births in humans is still unknown. Prostaglandins, by mediating cervical ripening and early stimulation of myometrial contractions, are likely to play a major role in the parturition process. Much of the unique fetal circulation is facilitated by the ductus arteriosus. Patency of the ductus arteriosus in utero is primarily maintained via prostaglandins which are highly expressed by smooth muscle cells located in the media of the ductus arteriosus. The primary objective of this study is to prospectively assess whether any changes in the fetal ductus arteriosus parameters exist at 32 weeks' gestation. The secondary objective is to investigate whether there is an association between the ductus arteriosus parameters and the time to delivery interval at 32 weeks' gestation.
Detailed Description
The rationale is to assess whether physiological responses that occur around the time of delivery, in both the mother and the fetus (elevated prostaglandins level), can be quantified using ultrasound of the fetal ductus arteriosus. Whether or not the ductus arteriosus plays an active physiological role in the initiation of parturition is unknown. Since prostaglandins are physiologically highly expressed within the fetal ductus arteriosus and also linked to some critical steps throughout parturition, it is hypothesized that structural and doppler flow pattern variations of the ductus arteriosus exist in the period surrounding the birth. These changes might occur before or after the intrinsic rise of prostaglandins and could be quantified using prenatal ultrasound of the fetal ductus arteriosus. Identifying new physiological based variables that can assist in predicting the onset of labour, especially surrounding preterm birth, as the one suggested in the current study, is thus of great importance and may provide invaluable information into the overall future care and decision making during pregnancy, especially around the time of delivery. It may assist in creating future recommendations for pregnant women and improved healthcare standards during the delivery process.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductus Arteriosus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound examination
Arm Type
Other
Arm Description
Participants will undergo an ultrasound examination at 32 weeks gestation.
Intervention Type
Other
Intervention Name(s)
Ultrasound examination
Intervention Description
Participants will undergo ultrasound examination at 32 weeks gestation
Primary Outcome Measure Information:
Title
Fetal ductus arteriosus changes
Description
To prospectively assess any changes in blood flow in the fetal ductus arteriosus at 32 weeks' gestation.
Time Frame
32 weeks gestation
Secondary Outcome Measure Information:
Title
Time to delivery
Description
To investigate whether there is an association between the ductus arteriosus parameters and the time to delivery interval at 32 weeks' gestation.
Time Frame
32 weeks gestation to delivery

10. Eligibility

Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Low risk singleton pregnancy at 32 weeks gestation. Exclusion criteria: Smoking Underlying cardiac or respiratory illness Fetal growth restriction Medicated gestational hypertension or evolving preeclampsia Gestational diabetes controlled with insulin or oral medications Use of steroids for lung maturation in the current pregnancy Known major congenital anomalies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Berger, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Preterm Birth

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