NCT03321435

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

10 months

First QC Date

October 21, 2017

Last Update Submit

November 14, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Estimated fetal wight (gram)

    4 weeks

Secondary Outcomes (1)

  • The value of Doppler indices in uterine artery

    4 weeks

Study Arms (2)

placenta previa group

Other: placenta previa patient

Normal control group

Other: normal women

Interventions

women had placenta previa either major or minor degree

placenta previa group

those women had not placenta previa

Normal control group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

placenta previa patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 21, 2017

First Posted

October 25, 2017

Study Start

October 1, 2016

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11