Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women

Placenta Previa Clinical Trial

Official title:

Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women: a Prospective, Matched Case-control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03774667
• Other study ID #: MCHHFoshan-1901
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2021
• Source: Maternal and Child Health Hospital of Foshan
• Contact: Zhengping Liu, MD
• Phone: 86 757 82969772
• Email: liuzphlk81[@]outlook.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study aim to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Gender: Female
• Age group: 12 Years to 60 Years

Eligibility

Inclusion Criteria:

• Single Pregnancy

• Informed consent

• Fetal gestational age 28 to < 42 weeks

Exclusion Criteria:

• Multiple pregnancy

• Refuses to consent

Related Conditions & MeSH terms

• Placenta Previa

Locations

Country	Name	City	State
China	Maternal and Child Health Hospital of Foshan	Foshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Maternal and Child Health Hospital of Foshan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with postpartum hemorrhage	Blood loss > 1000ml during cesarean section or > 500 ml during vaginal delivery	24 hours after delivery
Secondary	Number of Participants with antepartum hemorrhage	At least one episode of bleeding from the genital tract during the antenatal period	From the time of viability of pregnancy to the delivery of the baby, assessed up to 42 weeks
Secondary	Number of Participants with preterm birth	Before 37 completed gestational weeks	From the time of viability of pregnancy to the delivery of the baby, assessed up to 37 weeks
Secondary	Number of Participants with very preterm birth	Before 32 completed gestational weeks	From the time of viability of pregnancy to the delivery of the baby, assessed up to 32 weeks
Secondary	Number of participant needed for blood transfusion	Calculation of the number of participant needed for blood transfusion	72 hours after delivery
Secondary	Number of urological injury	Calculation of the number of participant with bladder or ureteric injury	72 hours after delivery
Secondary	Number of needed for extra surgical maneuvers	internal iliac ligation or hysterectomy	72 hours after delivery
Secondary	Number of need for caesarean hysterectomy	Yes or no	72 hours after delivery
Secondary	Number of needed for neonatal ICU	Yes or no	72 hours after delivery
Secondary	Number of needed for maternal ICU	Yes or no	72 hours after delivery