Clinical trial NCT03321435: The Placenta Previa and Fetal Weight
Official title: The Effect of Placenta Previa on Fetal Weight and Feto-maternal Blood Flow
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placenta Previa
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: placenta previa patients

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.


Eligibility 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

Primary outcomes:
measure: Estimated fetal wight (gram)
timeFrame: 4 weeks
Secondary outcomes:
measure: The value of Doppler indices in uterine artery
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References: