Maternal and neonatal outcomes in placenta previa deliveries
| ISRCTN | ISRCTN46834750 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46834750 |
- Submission date
- 26/03/2019
- Registration date
- 28/03/2019
- Last edited
- 09/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Scientific
11 Renminxi Road
Foshan
528000
China
 ORCID ID |
0000-0002-4964-0258 |
|---|---|
| Phone | +86 (0)757 82969878 |
| liuzphlk81@outlook.com |
Scientific
11 Renminxi Road
Foshan
528000
China
| ORCID ID |
0000-0003-2773-9166 |
|---|---|
| Phone | +86 (0)757 82969878 |
| fandazhigw@163.com |
Study information
| Study design | Single-center retrospective hospital-based case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Maternal and neonatal outcomes in placenta previa deliveries: a retrospective case-control study |
| Study objectives | Placenta previa can increase the risk of maternal and neonatal outcomes. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/02/2019 |
| Completion date | 31/01/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1000 |
| Key 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. |
| Key exclusion criteria | Before 28 completed gestational weeks |
| Date of first enrolment | 01/05/2019 |
| Date of final enrolment | 30/11/2020 |
Locations
Countries of recruitment
- China
Study participating centre
Foshan
528000
China
Sponsor information
Hospital/treatment centre
11 Renminxi Road
Foshan
528000
China
| Phone | +86 (0)757 82969772 |
|---|---|
| trials_fs_mchh@sohu.com | |
| Website | https://www.fsfy.com/Index.html |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in peer-review journals once the data analysis is complete. |
| IPD sharing plan | Prof. Zhengping Liu (liuzphlk81@outlook.com) or Dr Dazhi Fan (fandazhigw@163.com) should be contacted for access to the datasets after the trial. |
Editorial Notes
09/12/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/11/2019 to 30/11/2020.
2. The overall end date was changed from 31/01/2020 to 31/01/2021.
3. The intention to publish date was changed from 31/01/2021 to 31/01/2022.
4. The plain English summary was updated to reflect these changes.
07/11/2019: Ethics approval details added.
