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 2021 (updated 09/12/2019, previously: 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
Approved 16/05/2019, 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
31/01/2021
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
30/11/2020
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
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
31/01/2022
Participant level data
Available on request
Basic results (scientific)
Publication list