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

Ductus Arteriosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03073460
• Other study ID #: 16-037
• Status: Withdrawn
• Phase: N/A
• Start date: June 2, 2016
• Est. completion date: March 28, 2020

Study information

• Verified date: April 2020
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 DA plays an active physiological role in the initiation of parturition is still 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 DA.

Identifying new physiological based variables that can assist in predicting the onset of labour, 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: March 28, 2020
• Est. primary completion date: March 28, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Low risk singleton pregnancy at 40 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

Intervention

Other:
• Ultrasound examination
This exam is performed at 40 weeks gestation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to delivery	To investigate whether there is an association between the ductus arteriosus blood flow and the time to delivery interval at 40 weeks' gestation.	From 40 weeks gestation to delivery