The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Labour at Term
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|ClinicalTrials.gov Identifier: NCT03073460|
Recruitment Status : Withdrawn (Not able to recruit any participants)
First Posted : March 8, 2017
Last Update Posted : April 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ductus Arteriosus||Other: Ultrasound examination||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Labour at Term|
|Estimated Study Start Date :||June 2, 2016|
|Actual Primary Completion Date :||March 28, 2020|
|Actual Study Completion Date :||March 28, 2020|
Participants will undergo an ultrasound examination at 40 weeks gestation to assess the fetal ductus arteriosis.
Other: Ultrasound examination
This exam is performed at 40 weeks gestation
- Fetal ductus arteriosus changes [ Time Frame: 40 weeks gestation ]To prospectively assess whether any changes in blood flow in the fetal ductus arteriosus exist at 40 weeks' gestation.
- Time to delivery [ Time Frame: From 40 weeks gestation 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073460
|Principal Investigator:||Howard Berger, MD||St. Michael's Hospital, Toronto|