The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Preterm Birth

Ductus Arteriosus Clinical Trial

Official title:

The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Preterm Birth

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03073512
• Other study ID #: 16-038
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 1, 2024

Study information

• Verified date: December 2023
• Source: Unity Health Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ductus Arteriosus
• Ductus Arteriosus, Patent
• Premature Birth

Intervention

Other:
• Ultrasound examination
Participants will undergo ultrasound examination at 32 weeks gestation

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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