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The Placenta Previa and Fetal Weight

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ClinicalTrials.gov Identifier: NCT03321435
Recruitment Status : Completed
First Posted : October 25, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

Brief Summary:

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.


Condition or disease Intervention/treatment
Placenta Previa Other: placenta previa patient Other: normal women

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Placenta Previa on Fetal Weight and Feto-maternal Blood Flow
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Group/Cohort Intervention/treatment
placenta previa group Other: placenta previa patient
women had placenta previa either major or minor degree

Normal control group Other: normal women
those women had not placenta previa




Primary Outcome Measures :
  1. Estimated fetal wight (gram) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. The value of Doppler indices in uterine artery [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
placenta previa patients
Criteria

Inclusion Criteria:

  1. Women who are sure of her pregnancy.
  2. Women aged 20-35 years.
  3. Women with BMI 18-22 kg/m2.
  4. Estimated gestational age is ranging between 30- 32 weeks gestation.
  5. Singleton pregnancy.
  6. Placenta previa; either major or minor degrees as regard the cases.
  7. Placenta previa with minimal vaginal bleeding or haven't any vaginal bleeding.
  8. Women with normal Doppler indices in uterine and umbilical arteries at time of recruitment.
  9. Women should be living in a nearby area to make follow-up and early transportation are reasonably possible.

Exclusion Criteria:

  1. Women aged < 20 and >35 years.
  2. Smoker ≥ 11 cigarettes/day.
  3. Severe attack of bleeding requiring an immediate intervention.
  4. Fetal heart rates instability or non reassuring.
  5. Multiple gestations.
  6. Previous Intrauterine growth restricted fetus.
  7. Intrauterine fetal death or major fetal anomalies.
  8. If associated with abruptio placentae.
  9. Patients with known bleeding disorders or on anticoagulant therapy

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Responsible Party: Mohammed Khairy Ali, Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03321435     History of Changes
Other Study ID Numbers: PPIUGR
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Placenta Previa
Fetal Weight
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases
Body Weight
Signs and Symptoms