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The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Labour at Term

Primary Purpose

Ductus Arteriosus

Status
Withdrawn
Phase
Not Applicable
Locations
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)FemaleDoes not accept healthy volunteers

Inclusion criteria:

  • Low risk singleton pregnancy at 40 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

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Ultrasound examination

    Arm Description

    Participants will undergo an ultrasound examination at 40 weeks gestation to assess the fetal ductus arteriosis.

    Outcomes

    Primary Outcome Measures

    Fetal ductus arteriosus changes
    To prospectively assess whether any changes in blood flow in the fetal ductus arteriosus exist at 40 weeks' gestation.

    Secondary Outcome Measures

    Time to delivery
    To investigate whether there is an association between the ductus arteriosus blood flow and the time to delivery interval at 40 weeks' gestation.

    Full Information

    First Posted
    February 15, 2017
    Last Updated
    April 28, 2020
    Sponsor
    Unity Health Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03073460
    Brief Title
    The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Labour at Term
    Official Title
    The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Labour at Term
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Not able to recruit any participants
    Study Start Date
    June 2, 2016 (Anticipated)
    Primary Completion Date
    March 28, 2020 (Actual)
    Study Completion Date
    March 28, 2020 (Actual)

    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
    The exact mechanism stimulating the parturition in humans is still relatively 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 aim of the study is to prospectively observe fetal ultrasound changes related to the ductus arteriosus. The primary objective is to prospectively assess, whether any changes in the fetal ductus arteriosus parameters exist at 40 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 40 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 DA plays an active physiological role in the initiation of parturition is still 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 DA. Identifying new physiological based variables that can assist in predicting the onset of labour, 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 40 weeks gestation to assess the fetal ductus arteriosis.
    Intervention Type
    Other
    Intervention Name(s)
    Ultrasound examination
    Intervention Description
    This exam is performed at 40 weeks gestation
    Primary Outcome Measure Information:
    Title
    Fetal ductus arteriosus changes
    Description
    To prospectively assess whether any changes in blood flow in the fetal ductus arteriosus exist at 40 weeks' gestation.
    Time Frame
    40 weeks gestation
    Secondary Outcome Measure Information:
    Title
    Time to delivery
    Description
    To investigate whether there is an association between the ductus arteriosus blood flow and the time to delivery interval at 40 weeks' gestation.
    Time Frame
    From 40 weeks gestation to delivery

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Women with a singleton pregnancy
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Low risk singleton pregnancy at 40 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Labour at Term

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