- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03073460
The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Labour at Term
Study Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Ultrasound examination
Participants will undergo an ultrasound examination at 40 weeks gestation to assess the fetal ductus arteriosis.
|
This exam is performed at 40 weeks gestation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
40 weeks gestation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From 40 weeks gestation to delivery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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