An observational study in Placenta Previa, sponsored by Maternal and Child Health Hospital of Foshan. Status unknown at 1 site in China. Open to female participants aged 12 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-06-09.
Sponsored by Maternal and Child Health Hospital of Foshan · Observational
This study aim to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa.
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.
80 studies on the registry are indexed under Placenta Previa; 17 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 100 across 32 observational studies indexed under Placenta Previa.
Browse Placenta Previa studies →Maternal and Child Health Hospital of Foshan is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women is diagnosed with placenta previa after delivery and their matched pregnant women.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Number of Participants with postpartum hemorrhage
Blood loss \> 1000ml during cesarean section or \> 500 ml during vaginal delivery
Time frame: 24 hours after delivery
Number of Participants with antepartum hemorrhage
At least one episode of bleeding from the genital tract during the antenatal period
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
Before 37 completed gestational weeks
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
Before 32 completed gestational weeks
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
Calculation of the number of participant needed for blood transfusion
Time frame: 72 hours after delivery
Number of urological injury
Calculation of the number of participant with bladder or ureteric injury
Time frame: 72 hours after delivery
Number of needed for extra surgical maneuvers
internal iliac ligation or hysterectomy
Time frame: 72 hours after delivery
Number of need for caesarean hysterectomy
Yes or no
Time frame: 72 hours after delivery
Number of needed for neonatal ICU
Yes or no
Time frame: 72 hours after delivery
Number of needed for maternal ICU
Yes or no
Time frame: 72 hours after delivery
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Six months after completion of the study
No publications or documents are linked to this record.
Started Jan 2019 (actual). Primary completion is estimated for Dec 2021, 35 months after the start.
Of 15 observational studies under Placenta Previa, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 36. This study's planned 35 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Maternal and Child Health Hospital of Foshan