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Mode of Delivery in Women With Low-lying Placenta (MODEL-PLACENTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04827433
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
University of Milano Bicocca

Study Description
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Brief Summary:
Multicentre study; observational, longitudinal prospective, case-control

Condition or disease
Low-Lying; Placenta, Hemorrhage, Complicating Delivery

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Study Design
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Study Type : Observational
Estimated Enrollment : 2550 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Mode of Delivery in Women With Low-lying Placenta: an Italian Multicentre Study
Actual Study Start Date : October 28, 2020
Estimated Primary Completion Date : October 28, 2024
Estimated Study Completion Date : April 28, 2025
Groups and Cohorts
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Group/Cohort
Women having a persistent low-lying placenta with an IOD between 6 and 20 mm
Women having a persistent low-lying placenta with an IOD between 6 and 20 mm who will be offered a vaginal birth, considering 3 subgroups: 1) 6-10 mm; 2) 11-20mm; 3) > 20 mm (resolution of previa or low-lying placenta)
Women with normal located placenta
Women with a normally located placenta at the II trimester scan will represent the control group.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of vaginal delivery and urgent cesarean section [ Time Frame: Until the end of the study (approximately 54 months). ]
    Rate of vaginal birth and emergency cesarean section in labor due to vaginal bleeding


Secondary Outcome Measures :
  1. Frequency of resolution of placenta previa or low-lying [ Time Frame: Until the end of the study (approximately 54 months). ]
    Frequency of resolution of placenta previa or low-lying in relation to the placental location at the time of diagnosis and in relation to maternal history of hysterotomy

  2. Placental migration speed and its correlation with different variables [ Time Frame: Until the end of the study (approximately 54 months). ]
    Description of time needed for resolution of previa or low-lying placenta in relation to placental location at diagnosis (anterior/posterior; praevia/low-lying), and maternal history of hysterotomy, and its correlation to the mode of birth and risk of bleeding during pregnancy and in labor.

  3. Frequency of ultrasound visualization of the marginal breast in low-lying placentas and other variables [ Time Frame: Until the end of the study (approximately 54 months). ]
    Frequency of marginal sinus in women with low-lying placenta and its relation with mode of birth and risk of ante-, intra-, and post-partum bleeding.

  4. Refusal of elective caesarean section [ Time Frame: Until the end of the study (approximately 54 months). ]
    Rate of women declining the mode of birth suggested by clinicians during counselling.

  5. Morbidity associated with the various groups of placental distance analyzed by the antepartum hemorrhage incidence. [ Time Frame: Until the end of the study (approximately 54 months). ]
    Incidence of antepartum hemorrhage requiring hospital admission or immediate delivery.

  6. Morbidity associated with the various groups of placental distance studied with the intrapartum hemorrhage incidence. [ Time Frame: Until the end of the study (approximately 54 months). ]
    Incidence of intrapartum hemorrhage requiring emergency CS.

  7. Morbidity associated with the various groups of placental distance through the severe postpartum hemorrhage incidence. [ Time Frame: Until the end of the study (approximately 54 months). ]
    Incidence of severe postpartum hemorrhage, defined as bleeding ≥ 1000 ml following birth and administration of uterotonic drugs, use of balloon tamponade, uterine artery embolization, ligature of uterine arteries, hysterectomy, blood transfusion;

  8. Morbidity associated with the various groups of placental distance associated with the admission to Intensive Care Unit (ICU) [ Time Frame: Until the end of the study (approximately 54 months). ]
    The maternal admission to ICU.

  9. Morbidity associated with the various groups of placental distance described by the preterm bith incidence [ Time Frame: Until the end of the study (approximately 54 months). ]
    Incidence of preterm birth can described the morbidity associated wiith the various groups of placenta distance.

  10. Morbidity associated with the various groups of placental distance described through the preterm incidence less than 32 weeks. [ Time Frame: Until the end of the study (approximately 54 months). ]
    Incidence of preterm birth < 32 weeks.

  11. Morbidity associated with the various groups of placental distance according to the neonatal admission to ICU [ Time Frame: Until the end of the study (approximately 54 months). ]
    Neonatal admission to Neonatal ICU and length of stay.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Women having a persisten low-lying placenta with an IOD between 6 and 20 mm and women with a resolved previa or low-lying placenta with an IOD > 20 mm who will be offered a trial of labor.

A control group will be represented by women with a normal placental location at the II trimester scan.

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04827433


Contacts
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Contact: Elisabetta Colciago 0392332657 elisabetta.colciago@gmail.com
Contact: Isadora Vaglio Tessitore 0392332657 i.vagliotessitore@campus.unimib.it

Locations
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Sponsors and Collaborators
University of Milano Bicocca
Investigators
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Principal Investigator: Sara Ornaghi sara.ornaghi@unimib.it
Study Director: Patrizia Vergani patrizia.vergani@unimib.it
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT04827433    
Other Study ID Numbers: MODEL-PLACENTA STUDY
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Milano Bicocca:
low-lying placenta
mode of birth
labor and birth
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes