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

Not Applicable

Withdrawn

• Conditions: Ductus Arteriosus
• Interventions: Other: Ultrasound examination

• Registration Number: NCT03073460
• Lead Sponsor: Unity Health Toronto

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 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.

Study Timeline

• Study Start: 2016-06-02
• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-08
• Primary Completion: 2020-03-28
• Study Completion: 2020-03-28
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to delivery	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.