Status:
UNKNOWN
Mode of Delivery in Women With Low-lying Placenta
Lead Sponsor:
University of Milano Bicocca
Conditions:
Low-Lying; Placenta, Hemorrhage, Complicating Delivery
Eligibility:
FEMALE
18+ years
Brief Summary
Multicentre study; observational, longitudinal prospective, case-control
Detailed Description
This is a new protocol to evaluate the mode of birth in women with a low-lying placenta. In particular, we intend to propose a vaginal birth in women having a low-lying placenta with a distance betwee...
Eligibility Criteria
Inclusion
- Minimum age of 18
- Women with placenta previa or low-lying placenta confirmed by TVS at 19-23 6/7 weeks of gestation.
- Women attending Maternity Triage with vaginal bleeding at \< 32 weeks of gestation, with a diagnosis of placenta previa or low-lying placenta and not requiring an emergency delivery.
- Women with a normally located placenta at the II trimester ultrasound scan, at 19-23 6/7 week of gestation (control group)
- Single pregnancy
- Signature of the informed consent to participate in the study
- Note: Women of the "control group" will be recruited in a 1:3 ratio. After the inclusion of 1 case, 3 women with a normally located placenta will be recruited, according to the parity of the woman representing the case (e.g.: 1 CASE= nulliparous woman, 3 CONTROLS= 3 nulliparous women).
Exclusion
- Suspected or confirmed invasive placentation (i.e., placenta accreta)
- Vaginal bleeding requiring emergency delivery
- Inability to meet the conditions set out in the study protocol
Key Trial Info
Start Date :
October 28 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 28 2025
Estimated Enrollment :
2550 Patients enrolled
Trial Details
Trial ID
NCT04827433
Start Date
October 28 2020
End Date
April 28 2025
Last Update
January 2 2024
Active Locations (17)
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1
Ospedale Papa Giovanni XXIII
Bergamo, Italy
2
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy
3
Ospedale Spedali Civili
Brescia, Italy
4
Ospedale Vittorio Emanuele III
Carate Brianza, Italy