NCT03774667

Brief Summary

This study aim to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 5, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

June 9, 2021

Status Verified

June 1, 2021

Enrollment Period

3 years

First QC Date

December 5, 2018

Last Update Submit

June 7, 2021

Conditions

Keywords

Placenta PreviaRisk FactorsPerinatal ComplicationsPerinatal Outcomes

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with postpartum hemorrhage

    Blood loss \> 1000ml during cesarean section or \> 500 ml during vaginal delivery

    24 hours after delivery

Secondary Outcomes (9)

  • Number of Participants with antepartum hemorrhage

    From the time of viability of pregnancy to the delivery of the baby, assessed up to 42 weeks

  • Number of Participants with preterm birth

    From the time of viability of pregnancy to the delivery of the baby, assessed up to 37 weeks

  • Number of Participants with very preterm birth

    From the time of viability of pregnancy to the delivery of the baby, assessed up to 32 weeks

  • Number of participant needed for blood transfusion

    72 hours after delivery

  • Number of urological injury

    72 hours after delivery

  • +4 more secondary outcomes

Study Arms (2)

Placenta Previa

Pregnant women is diagnosed with placenta previa after delivery. Placenta previa is diagnosed by experienced ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering the internal cervical os before delivery, and further confirmed by obstetricians at delivery.

None-Placenta Previa

Pregnant women is diagnosed without placenta previa after delivery. Placenta previa is diagnosed by experienced ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering the internal cervical os before delivery, and further confirmed by obstetricians at delivery.

Eligibility Criteria

Age12 Years - 60 Years
Sexfemale
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women is diagnosed with placenta previa after delivery and their matched pregnant women.

You may qualify if:

  • Single Pregnancy
  • Informed consent
  • Fetal gestational age 28 to \< 42 weeks

You may not qualify if:

  • Multiple pregnancy
  • Refuses to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternal and Child Health Hospital of Foshan

Foshan, Guangdong, 528000, China

RECRUITING

MeSH Terms

Conditions

Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 13, 2018

Study Start

January 1, 2019

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

June 9, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Six months after completion of the study

Locations