Brief Title
The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Labour at Term
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 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 Type
Interventional
Primary Outcome
Fetal ductus arteriosus changes
Secondary Outcome
Time to delivery
Condition
Ductus Arteriosus
Intervention
Ultrasound examination
Study Arms / Comparison Groups
Ultrasound examination
Description: Participants will undergo an ultrasound examination at 40 weeks gestation to assess the fetal ductus arteriosis.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
0
Start Date
June 2, 2016
Completion Date
March 28, 2020
Primary Completion Date
March 28, 2020
Eligibility Criteria
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.
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Howard Berger, MD, ,
Administrative Informations
NCT ID
NCT03073460
Organization ID
16-037
Responsible Party
Sponsor
Study Sponsor
Unity Health Toronto
Study Sponsor
Howard Berger, MD, Principal Investigator, Unity Health Toronto
Verification Date
April 2020