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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03073460
Recruitment Status : Withdrawn (Not able to recruit any participants)
First Posted : March 8, 2017
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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.

Condition or disease Intervention/treatment Phase
Ductus Arteriosus Other: Ultrasound examination Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Labour at Term
Estimated Study Start Date : June 2, 2016
Actual Primary Completion Date : March 28, 2020
Actual Study Completion Date : March 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Ultrasound examination
Participants will undergo an ultrasound examination at 40 weeks gestation to assess the fetal ductus arteriosis.
Other: Ultrasound examination
This exam is performed at 40 weeks gestation




Primary Outcome Measures :
  1. Fetal ductus arteriosus changes [ Time Frame: 40 weeks gestation ]
    To prospectively assess whether any changes in blood flow in the fetal ductus arteriosus exist at 40 weeks' gestation.


Secondary Outcome Measures :
  1. Time to delivery [ Time Frame: From 40 weeks gestation 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women with a singleton pregnancy
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073460


Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Howard Berger, MD St. Michael's Hospital, Toronto
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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03073460    
Other Study ID Numbers: 16-037
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities