Clinical Trial: The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Labour at Term
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Labour at Term
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.
Detailed Summary:
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.
Sponsor: St. Michael's Hospital, Toronto
Current Primary Outcome: Fetal ductus arteriosus changes [ Time Frame: 40 weeks gestation ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Time to delivery [ Time Frame: From 40 weeks gestation to delivery ]
Original Secondary Outcome: Same as current
Information By: St. Michael's Hospital, Toronto
Dates:
Date Received: February 15, 2017
Date Started: June 2, 2016
Date Completion: June 2, 2018
Last Updated: March 7, 2017
Last Verified: February 2017
