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

NCT03073460 | Withdrawn

• 1 other identifier: 16-037
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ductus Arteriosus

Outcome Measures

Primary Outcomes (1)

• Fetal ductus arteriosus changes

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

  40 weeks gestation

Secondary Outcomes (1)

• Time to delivery

  From 40 weeks gestation to delivery

Study Arms (1)

Ultrasound examination

OTHER

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

Other: Ultrasound examination

Interventions

Ultrasound examination OTHER

This exam is performed at 40 weeks gestation

Ultrasound examination

Eligibility Criteria

• Gender Eligibility Details: Women with a singleton pregnancy
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Low risk singleton pregnancy at 40 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

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: June 2, 2016
• Primary Completion: March 28, 2020
• Study Completion: March 28, 2020
• Last Updated: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share