Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women

NCT ID: NCT03774667

Last Updated: 2021-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-06-30

Brief Summary

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

Detailed Description

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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

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Placenta Previa

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Multiple pregnancy
* Refuses to consent
Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maternal and Child Health Hospital of Foshan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maternal and Child Health Hospital of Foshan

Foshan, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhengping Liu, MD

Role: CONTACT

86 757 82969772

Dazhi Fan, MD

Role: CONTACT

86 757 82969772

Facility Contacts

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Zhengping Liu, MD

Role: primary

86 757 82969772

Dazhi Fan, MD

Role: backup

86 757 82969772

Other Identifiers

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MCHHFoshan-1901

Identifier Type: -

Identifier Source: org_study_id

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