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CompletedNCT03321435Updated Nov 17, 2017

The Placenta Previa and Fetal Weight

An observational study in Placenta Previa, sponsored by Assiut University. Completed. Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-17.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
20 Years to 35 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Placenta Previa
03

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

placenta previa patients

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • placenta previa group

    Other: placenta previa patient

  • Normal control group

    Other: normal women

Interventions

  • Otherplacenta previa patient

    women had placenta previa either major or minor degree

  • Othernormal women

    those women had not placenta previa

05

What researchers measure

Primary outcomes

  1. Estimated fetal wight (gram)

    Time frame: 4 weeks

Secondary outcomes

  1. The value of Doppler indices in uterine artery

    Time frame: 4 weeks

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03321435
Lead sponsor
Assiut University
Responsible party
Mohammed Khairy Ali (Lecturer, Assiut University) — Principal investigator
First posted
Oct 25, 2017
Start date
Oct 1, 2016
Primary completion
Aug 1, 2017
Completion
Oct 1, 2017
Last update
Nov 17, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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