Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women

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.

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Zhengping Liu, MD; Phone Number: 86 757 82969772; Email: liuzphlk81@outlook.com
• Study Contact Backup: Name: Dazhi Fan, MD; Phone Number: 86 757 82969772; Email: fandazhigw@163.com

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Recruiting
      • Maternal and Child Health Hospital of Foshan
      • Contact: Zhengping Liu, MD; Phone Number: 86 757 82969772; Email: liuzphlk81@outlook.com
      • Contact: Dazhi Fan, MD; Phone Number: 86 757 82969772; Email: fandazhigw@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women is diagnosed with placenta previa after delivery and their matched pregnant women.

Description

Inclusion Criteria:

• Single Pregnancy
• Informed consent
• Fetal gestational age 28 to < 42 weeks

Exclusion Criteria:

• Multiple pregnancy
• Refuses to consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with postpartum hemorrhage	Blood loss > 1000ml during cesarean section or > 500 ml during vaginal delivery	24 hours after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Number of participant needed for blood transfusion	Calculation of the number of participant needed for blood transfusion	72 hours after delivery
Number of urological injury	Calculation of the number of participant with bladder or ureteric injury	72 hours after delivery
Number of needed for extra surgical maneuvers	internal iliac ligation or hysterectomy	72 hours after delivery
Number of need for caesarean hysterectomy	Yes or no	72 hours after delivery
Number of needed for neonatal ICU	Yes or no	72 hours after delivery
Number of needed for maternal ICU	Yes or no	72 hours after delivery

Collaborators and Investigators

• Sponsor: Maternal and Child Health Hospital of Foshan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (Actual): December 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Risk Factors; Perinatal Outcomes; Placenta Previa; Perinatal Complications
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Previa
• Other Study ID Numbers: MCHHFoshan-1901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Six months after completion of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No