The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Preterm Birth

NCT03073512 | Withdrawn

• 1 other identifier: 16-038
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ductus Arteriosus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to delivery

  32 weeks gestation to delivery

Study Arms (1)

Ultrasound examination

OTHER

Participants will undergo an ultrasound examination at 32 weeks gestation.

Other: Ultrasound examination

Interventions

Ultrasound examination OTHER

Participants will undergo ultrasound examination at 32 weeks gestation

Ultrasound examination

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low risk singleton pregnancy at 32 weeks gestation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Howard Berger, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: March 8, 2017
• Study Start: January 1, 2020
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)