- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03321435
The Placenta Previa and Fetal Weight
The Effect of Placenta Previa on Fetal Weight and Feto-maternal Blood Flow
Placenta previa is a placenta that implants at lower uterine segment, it occurs in about 0.3-0.5% of pregnancies at term. It is a significant risk for development of maternal morbidity, as well as maternal mortality secondary to maternal hemorrhage . Also, this abnormal placenta has a negative concern about fetal well being due to prematurity and perinatal mortality, in addition to its undesirable effect on fetal growth. Several factors may be behind of the effect of placenta previa on fetal growth. Firstly, the blood supply to the lower uterine segment is less than at the upper segment apparently resulting in less feto-placental blood perfusion . Secondly, recurrent bleeding attacks from placental previa may affect fetal oxygenation and fetal growth.
In spite of above evidences; many studies in literature denied the relation between placenta previa and fetal growth and concluded that the association between low birth weight and placenta previa is mainly due to preterm delivery and to a lesser extent with fetal growth restriction. However; the major drawback of all these studies is lacking of reporting the effect of placenta previa of feto-maternal blood flow representing in studying of Doppler blood flow in both uterine and umbilical artery in those patients. The uterine artery blood flow is usually affected by the presence of placenta previa and placenta accreta which reflected on feto-placental blood flow. So the uterine artery Doppler velocimetry is a useful tool for predicting placenta accreta .
So in the light of above evidences; we aimed, in the current study, not only to investigate the effect on placenta previa on fetal weight but also to walk around the effect of placenta previa on the uterine and umbilical arteries blood flow in trial to explore this conflicting issue. To our knowledge, no previous trial had studied this interesting subject before.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women who are sure of her pregnancy.
- Women aged 20-35 years.
- Women with BMI 18-22 kg/m2.
- Estimated gestational age is ranging between 30- 32 weeks gestation.
- Singleton pregnancy.
- Placenta previa; either major or minor degrees as regard the cases.
- Placenta previa with minimal vaginal bleeding or haven't any vaginal bleeding.
- Women with normal Doppler indices in uterine and umbilical arteries at time of recruitment.
- Women should be living in a nearby area to make follow-up and early transportation are reasonably possible.
Exclusion Criteria:
- Women aged < 20 and >35 years.
- Smoker ≥ 11 cigarettes/day.
- Severe attack of bleeding requiring an immediate intervention.
- Fetal heart rates instability or non reassuring.
- Multiple gestations.
- Previous Intrauterine growth restricted fetus.
- Intrauterine fetal death or major fetal anomalies.
- If associated with abruptio placentae.
- Patients with known bleeding disorders or on anticoagulant therapy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
placenta previa group
|
women had placenta previa either major or minor degree
|
|
Normal control group
|
those women had not placenta previa
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Estimated fetal wight (gram)
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The value of Doppler indices in uterine artery
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
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
- PPIUGR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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