Placenta PreviaNCT03774667
Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women
An observational study of Placenta Previa, run by Maternal and Child Health Hospital of Foshan at 1 site in China.
Trial summary
This study aim to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa. Read more about this study
- Who is it for?
- Ages 12 to 60 years, women only
- Conditions the study is for
- Placenta Previa
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Jun 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- Women only
- Child, Adult
Study population: Pregnant women is diagnosed with placenta previa after delivery and their matched pregnant women.
Who may be able to join
- Single Pregnancy
- Informed consent
- Fetal gestational age 28 to < 42 weeks
Who cannot join
- Multiple pregnancy
- Refuses to consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Maternal and Child Health Hospital of Foshan
Foshan, Guangdong, 528000
Zhengping Liu, MD, 86 757 82969772, liuzphlk81@outlook.com
Dazhi Fan, MD, 86 757 82969772, fandazhigw@163.com
About this study
Official title: Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women: a Prospective, Matched Case-control Study
This study aim to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa.
Read the detailed description
Placenta previa (PP) is defined as the placenta overlying the endocervical os and grades according to the relationship and the distance between the lower placental edge and the internal os of the uterine cervix: low-lying previa, marginal previa, partial previa, and complete previa.
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.
It is associated with numerous adverse maternal and fetal-neonatal complications, such as perinatal hemorrhage, preterm birth, blood transfusion, hysterectomy, maternal intensive care unit admission, disseminated intravascular coagulation, septicemia, thrombophlebitis, and even fetal-neonatal and maternal death.
This is a 1:2 prospective, matched and hospital-based case-control study to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa. For each placenta previa women, the investigators selected two none-placenta previa pregnant women as control from the same department matched on the mode of delivery, using simple random selection when excess matches are available. The date of their admission is limited to two days.
This hospital is a tertiary university-affiliated medical center with a stable number of approximately 12,000 deliveries per year. 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.
- Conditions
- Placenta Previa
- Keywords
- Placenta Previa, Risk Factors, Perinatal Complications, Perinatal Outcomes
- Medical subject headings
- Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with postpartum hemorrhage
Blood loss > 1000ml during cesarean section or > 500 ml during vaginal delivery
Measured: 24 hours after delivery
Secondary outcomes (9)
Number of Participants with antepartum hemorrhage
At least one episode of bleeding from the genital tract during the antenatal period
Measured: From the time of viability of pregnancy to the delivery of the baby, assessed up to 42 weeks
Number of Participants with preterm birth
Before 37 completed gestational weeks
Measured: 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
Before 32 completed gestational weeks
Measured: 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
Calculation of the number of participant needed for blood transfusion
Measured: 72 hours after delivery
Number of urological injury
Calculation of the number of participant with bladder or ureteric injury
Measured: 72 hours after delivery
Number of needed for extra surgical maneuvers
internal iliac ligation or hysterectomy
Measured: 72 hours after delivery
Number of need for caesarean hysterectomy
Yes or no
Measured: 72 hours after delivery
Number of needed for neonatal ICU
Yes or no
Measured: 72 hours after delivery
Number of needed for maternal ICU
Yes or no
Measured: 72 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start1 Jan 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta PreviaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Maternal and Child Health Hospital of Foshan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774667
- Sponsor's protocol ID
- MCHHFoshan-1901
- Status last verified
- Jun 2021
- First submitted
- 5 Dec 2018
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women: a Prospective, Matched Case-control Study
- ClinicalTrials.gov ID
- NCT03774667
- Acronym / sponsor ID
- MCHHFoshan-1901
- Conditions
- Placenta Previa
- Keywords
- Placenta Previa, Risk Factors, Perinatal Complications, Perinatal Outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Maternal and Child Health Hospital of FoshanUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 13 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aim to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa.
Detailed description
Placenta previa (PP) is defined as the placenta overlying the endocervical os and grades according to the relationship and the distance between the lower placental edge and the internal os of the uterine cervix: low-lying previa, marginal previa, partial previa, and complete previa.
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.
It is associated with numerous adverse maternal and fetal-neonatal complications, such as perinatal hemorrhage, preterm birth, blood transfusion, hysterectomy, maternal intensive care unit admission, disseminated intravascular coagulation, septicemia, thrombophlebitis, and even fetal-neonatal and maternal death.
This is a 1:2 prospective, matched and hospital-based case-control study to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa. For each placenta previa women, the investigators selected two none-placenta previa pregnant women as control from the same department matched on the mode of delivery, using simple random selection when excess matches are available. The date of their admission is limited to two days.
This hospital is a tertiary university-affiliated medical center with a stable number of approximately 12,000 deliveries per year. 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Pregnant women is diagnosed with placenta previa after delivery and their matched pregnant women.
Key inclusion criteria (3 listed)
- Single Pregnancy
- Informed consent
- Fetal gestational age 28 to < 42 weeks
Key exclusion criteria (2 listed)
- Multiple pregnancy
- Refuses to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with postpartum hemorrhage
Time frame: 24 hours after delivery
Blood loss > 1000ml during cesarean section or > 500 ml during vaginal delivery
9 secondary outcomes
Number of Participants with antepartum hemorrhage
Time frame: From the time of viability of pregnancy to the delivery of the baby, assessed up to 42 weeks
Number of Participants with preterm birth
Time frame: 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
Time frame: 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
Time frame: 72 hours after delivery
Number of urological injury
Time frame: 72 hours after delivery
Number of needed for extra surgical maneuvers
Time frame: 72 hours after delivery
Number of need for caesarean hysterectomy
Time frame: 72 hours after delivery
Number of needed for neonatal ICU
Time frame: 72 hours after delivery
Number of needed for maternal ICU
Time frame: 72 hours after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Previa, run by Maternal and Child Health Hospital of Foshan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhengping Liu, MD (86 757 82969772, liuzphlk81@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with postpartum hemorrhage (time frame: 24 hours after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.