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The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Preterm Birth

The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Preterm Birth

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03073512
Enrollment
0
Registered
2017-03-08
Start date
2020-01-01
Completion date
2024-01-01
Last updated
2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ductus Arteriosus

Brief summary

Preterm birth still remains a major cause of perinatal morbidity and mortality worldwide. The exact mechanism stimulating term and preterm births in humans is still 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 primary objective of this study is to prospectively assess whether any changes in the fetal ductus arteriosus parameters exist at 32 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 32 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 ductus arteriosus plays an active physiological role in the initiation of parturition is 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 ductus arteriosus. Identifying new physiological based variables that can assist in predicting the onset of labour, especially surrounding preterm birth, 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.

Interventions

OTHERUltrasound examination

Participants will undergo ultrasound examination at 32 weeks gestation

Sponsors

Unity Health Toronto
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Low risk singleton pregnancy at 32 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.

Design outcomes

Primary

MeasureTime frameDescription
Fetal ductus arteriosus changes32 weeks gestationTo prospectively assess any changes in blood flow in the fetal ductus arteriosus at 32 weeks' gestation.

Secondary

MeasureTime frameDescription
Time to delivery32 weeks gestation to deliveryTo investigate whether there is an association between the ductus arteriosus parameters and the time to delivery interval at 32 weeks' gestation.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026