The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Preterm Birth

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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

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.
    


Study Type

Interventional


Primary Outcome

Fetal ductus arteriosus changes

Secondary Outcome

 Time to delivery

Condition

Ductus Arteriosus

Intervention

Ultrasound examination

Study Arms / Comparison Groups

 Ultrasound examination
Description:  Participants will undergo an ultrasound examination at 32 weeks gestation.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

0

Start Date

January 1, 2020

Completion Date

January 1, 2024

Primary Completion Date

January 1, 2020

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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Howard Berger, MD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT03073512

Organization ID

16-038


Responsible Party

Sponsor

Study Sponsor

St. Michael's Hospital, Toronto


Study Sponsor

Howard Berger, MD, Principal Investigator, St. Michael's Hospital, Toronto


Verification Date

February 2019