NCT02695069

Brief Summary

The purpose of this study is to assess the efficacy of random placenta margin incision for hemorrhage control during cesarean section of complete placenta previa pregnancies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

February 22, 2016

Last Update Submit

November 9, 2017

Conditions

Complete Placenta Previa

Keywords

Complete Placenta PreviaRandom Placenta Margin IncisionCesarean SectionHemorrhage

Outcome Measures

Primary Outcomes (1)

  • Postpartum Hemorrhage

    within the first 30 days after cesarean section

Secondary Outcomes (2)

  • Number of blood products transfused

    within the first 30 days after cesarean section

  • Length of hospitalization

    6 months after delivery

Study Arms (1)

All Participants

EXPERIMENTAL

A random hysterotomy incision is done in the placenta margin. To precisely determine the placental location and the edge of the placenta, preoperative ultrasonography is used in determining the optimal place for the uterine incision.

Procedure: Random Placenta Margin Incision

Interventions

Random Placenta Margin IncisionPROCEDURE

A random hysterotomy incision is done in the placenta margin. To precisely determine the placental location and the edge of the placenta, preoperative ultrasonography is used in determining the optimal place for the uterine incision.

All Participants

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A gestation age of ≥ 28 weeks
  • Delivered by cesarean section
  • Antepartum diagnosis of complete placenta accreta by obstetric ultrasound and doppler

You may not qualify if:

  • Women who refuse to participate
  • Pregnant women with serious diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternal and Child Health Hospital of Foshan

Foshan, Guangdong, 528000, China

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zhengping Liu, MD

    Maternal and Child Health Hospital of Foshan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 1, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2017

Study Completion

April 1, 2017

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations

CN(1)