The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Preterm Birth

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.

Study Overview

• Status: Withdrawn
• Conditions: Ductus Arteriosus
• Intervention / Treatment: Other: Ultrasound examination

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
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 2T2
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ultrasound examination; Participants will undergo an ultrasound examination at 32 weeks gestation.	Other: Ultrasound examination; Participants will undergo ultrasound examination at 32 weeks gestation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal ductus arteriosus changes	To prospectively assess any changes in blood flow in the fetal ductus arteriosus at 32 weeks' gestation.	32 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	32 weeks gestation to delivery

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Howard Berger, MD, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2020
• Primary Completion (Estimated): January 1, 2020
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Heart Defects, Congenital; Cardiovascular Abnormalities; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Ductus Arteriosus, Patent
• Other Study ID Numbers: 16-038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No