NCT02966197

Brief Summary

Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and even maternal death. Interventional radiological techniques have been developed to limit massive hemorrhage during caesarean section. This study investigated the efficacy of prophylactic internal iliac artery balloon catheterization in management for placenta previa and accreta.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

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

June 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

November 15, 2016

Last Update Submit

November 16, 2016

Conditions

Placenta PreviaPlacenta Accreta

Outcome Measures

Primary Outcomes (1)

  • blood loss

    intraoperative

Secondary Outcomes (3)

  • operation duration

    intraoperative

  • fluid transfusion

    intraoperative

  • blood transfusion

    intraoperative

Study Arms (2)

Balloon group

EXPERIMENTAL

Prophylactic Internal Iliac Artery Balloon Catheterization

Procedure: prophylactic internal iliac artery balloon catheterizationDevice: Prophylactic internal iliac artery balloonRadiation: Radiology operation

Control group

NO INTERVENTION

no intervention

Interventions

prophylactic internal iliac artery balloon catheterizationPROCEDURE

Between June 2015 and August 2016

Balloon group
Prophylactic internal iliac artery balloonDEVICE
Balloon group
Radiology operationRADIATION
Balloon group

Eligibility Criteria

Age15 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pregnant women were eligible if they were diagnosed to have placenta previa and accreta by sonographic examination or Magnetic Resonance Imaging.

You may not qualify if:

  • Any case who had bleeding disorder or underwent emergency cesarean delivery was excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Placenta PreviaPlacenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor, chief doctor

Study Record Dates

First Submitted

November 15, 2016

First Posted

November 17, 2016

Study Start

June 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 17, 2016

Record last verified: 2016-11