Condition category
Pregnancy and Childbirth
Date applied
26/03/2019
Date assigned
28/03/2019
Last edited
28/03/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Placenta previa is a condition where the placenta lies low in the uterus (womb) and partially or completely covers the cervix.. It is associated with numerous complications, such as perinatal hemorrhage (bleeding), preterm birth, blood transfusion, hysterectomy (removal of the womb), intensive care unit admission, disseminated intravascular coagulation, septicemia (blood poisoning), thrombophlebitis (blood clots), and even death. Cesarean delivery and assisted reproductive technology are associated with an increased risk of placenta previa in subsequent pregnancies. Other risk factors for previa include previous spontaneous, elective pregnancy terminations, previous uterine surgery, increasing maternal age and maternal parity, multiple gestations, smoking, cocaine use, and prior previa. The aim of this study is to investigate outcomes for pregnant women with placenta previa.

Who can participate?
Pregnant women diagnosed with placenta previa after delivery

What does the study involve?
Outcomes data is taken from electronic databases of findings collected as part of routine clinical care.

What are the possible benefits and risks of participating?
The possible benefits of this study are that eventually researchers may improve outcomes for pregnant women with placenta previa. No burdens or risks for participants are expected as the study is purely observational.

Where is the study run from?
The Southern Medical University Affiliated Maternal & Child Health Hospital of Foshan, Foshan, China

When is the study starting and how long is it expected to run for?
February 2019 to January 2020

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Prof. Zhengping Liu
liuzphlk81@outlook.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Zhengping Liu

ORCID ID

http://orcid.org/0000-0002-4964-0258

Contact details

11 Renminxi Road
Foshan
528000
China
+86 (0)757 82969878
liuzphlk81@outlook.com

Type

Scientific

Additional contact

Dr Dazhi Fan

ORCID ID

http://orcid.org/0000-0003-2773-9166

Contact details

11 Renminxi Road
Foshan
528000
China
+86 (0)757 82969878
fandazhigw@163.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Maternal and neonatal outcomes in placenta previa deliveries: a retrospective case-control study

Acronym

Study hypothesis

Placenta previa can increase the risk of maternal and neonatal outcomes.

Ethics approval

Approval pending, Medical Ethics Committee of Southern Medical University Affiliated Maternal & Child Health Hospital of Foshan (11 Renminxi Road, Foshan, Guangdong, 528000, China; Tel: +86 757 82969878; Email: trials_fs_mchh@sohu.com), ref: FSFY-20190201

Study design

Single-center retrospective hospital-based case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Placenta previa deliveries

Intervention

This is a single-center, retrospective, and hospital-based case-control study with one-year follow-up to investigate maternal and neonatal outcomes in pregnant women with placenta previa. For each woman with placenta previa, the investigators selected two non-placenta previa pregnant women as controls from the same department matched on the mode of delivery, using simple random selection when excess matches are available.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Number of participants with postpartum hemorrhage during cesarean section or vaginal delivery. The estimated blood loss is measured 24 hours after delivery by summing the amount of blood absorbed by medical gauze and the blood in the suction unit. If the total amount of blood loss in excess of 1000 ml during cesarean section or 500 ml during vaginal delivery, it is defined as post-partum hemorrhage.

Secondary outcome measures

1. Birth weight of the newborn is directly measured by nurses using electronic scales after delivery
2. Apgar score at 1 and 5 minutes is directly made by nurses according to Apgar scale at 1 and 5 minutes after delivery, respectively
3. Gestational age at delivery is determined on the basis of the last menstrual period and confirmed by an ultrasound scan taken between the 14th and 20th week
4. Number of participants with postpartum hysterectomy. If the uterus is removed after delivery due to childbirth, it is defined as postpartum hysterectomy

Overall trial start date

01/02/2019

Overall trial end date

31/01/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Pregnant women 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.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1000

Participant exclusion criteria

Before 28 completed gestational weeks

Recruitment start date

01/05/2019

Recruitment end date

30/11/2019

Locations

Countries of recruitment

China

Trial participating centre

Southern Medical University Affiliated Maternal & Child Health Hospital of Foshan
11 Renminxi Road
Foshan
528000
China

Sponsor information

Organisation

Southern Medical University Affiliated Maternal & Child Health Hospital of Foshan

Sponsor details

11 Renminxi Road
Foshan
528000
China
+86 (0)757 82969772
trials_fs_mchh@sohu.com

Sponsor type

Hospital/treatment centre

Website

https://www.fsfy.com/Index.html

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in peer-review journals once the data analysis is complete.

IPD sharing statement
Prof. Zhengping Liu (liuzphlk81@outlook.com) or Dr Dazhi Fan (fandazhigw@163.com) should be contacted for access to the datasets after the trial.

Intention to publish date

31/01/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes