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The Placenta Previa and Fetal Weight

NCT ID: NCT03321435

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-01

Study Completion Date

2017-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Placenta Previa

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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placenta previa group

placenta previa patient

Intervention Type OTHER

women had placenta previa either major or minor degree

Normal control group

normal women

Intervention Type OTHER

those women had not placenta previa

Interventions

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placenta previa patient

women had placenta previa either major or minor degree

Intervention Type OTHER

normal women

those women had not placenta previa

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Khairy Ali

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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PPIUGR

Identifier Type: -

Identifier Source: org_study_id