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

December 29, 2023 updated by: University of Milano Bicocca

Mode of Delivery in Women With Low-lying Placenta: an Italian Multicentre Study

Multicentre study; observational, longitudinal prospective, case-control

Study Overview

Status

Recruiting

Conditions

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 between the inferior placental edge and the internal cervical os, called internal-os-distance (IOD) of > 5 mm, as assessed in the late III trimester using transvaginal sonography.

Duration of the study:

  • Duration of the study: 54 months
  • Duration of enrollment: 42 months
  • Duration of follow-up completion of enrolled cases: 6 months
  • Duration of data analysis: 6 months

Study Design:

During the II trimester scan, all women presenting a placenta located in the lower uterine segment will undergo evaluation by Transvaginal Sonography (TVS).

If a placenta previa or a low-lying placenta will be confirmed, the woman will be recruited and asked to participate in our study, by signing a written informed consent. In addition women attending the Maternity Triage with vaginal bleeding at < 316/7 weeks of gestation, with a diagnosis of placenta previa or low-lying placenta and not requiring an emergency delivery will be asked to participate and will be recruited after signing the informed consent.

An expert Obstetrician will perform the TVS as scheduled, after inviting the woman to void.

The assessment will include:

  • the measurement of the IOD (first caliper on the internal cervical os and second caliper on the inferior placental edge). In case of a marginal sinus, the distance between the internal cervical os and the marginal sinus will also be assessed;
  • the cervical length (defined as shortened if ≤25 mm);
  • the placental edge thickness, measured within 1 cm from the meeting point between the basal and the chorionic plate. The placental edge will be considered "thick" if > 1cm or if the angle is >45°.

All women with a resolution of a previa or low-lying placenta will be assessed in accordance with the protocol of each participating Maternity Unit, including a scan assessment at 38-39 weeks of gestation or within 28 days from the due date.

Calculation of sample size / power:

Considering that the incidence of previa and low-lying placenta is approximately 2% at the II trimester scan and 0.4% at birth, and assuming a C.I. of 19% in the probability of vaginal birth in women with low-lying placenta/resolved low-lying (> 20 mm), 27 women will be needed for each participating Maternity Unit at the late III trimester scan. Anticipating a 10% drop out, 30 women will be needed to achieve a 95% statistical power to identify a clinically relevant difference in the rate of vaginal birth. This leads to the need of recruiting 150 women at the II trimester scan.

CRF and data management:

All data will be recorded through CRF provided by the promoter center and the database will be based on Microsoft Excel.

A sample of about 20-30 patients for each enrollment center is necessary to have a statistical power of 95% in detecting a clinically relevant difference in outcomes in the various study groups.

Analysis plan:

Descriptive statistics will be performed for all variables evaluated in the study population. Variables will be described by mean and standard deviation if normally distributed, otherwise by median and interquantile range; proportions will be used for categorical variables. The quantitative variables, among the study groups defined by the IOD at the last TVS, will be compared by parametric and non-parametric tests, whereas the categorical variables will be compared using Pearson's chi2 test (Fisher exact test where appropriate). The analyses for the primary outcome measure will be performed among women admitted to labor. A multivariate analysis will be conducted to assess the association between obstetric variables and vaginal birth.

A p-value<0.05 will be considered significant.

Study Type

Observational

Enrollment (Estimated)

2550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bergamo, Italy
        • Not yet recruiting
        • Ospedale Papa Giovanni XXIII
        • Contact:
          • Luisa Patane'
        • Principal Investigator:
          • Luigi Frigerio
      • Brescia, Italy
        • Recruiting
        • Fondazione Poliambulanza Istituto Ospedaliero
        • Contact:
          • Edoardo Barbolini
        • Principal Investigator:
          • Anna Catalano
      • Brescia, Italy
        • Not yet recruiting
        • Ospedale Spedali Civili
        • Contact:
          • Cristina Zanardini
        • Contact:
          • Valentina Parolin
        • Principal Investigator:
          • Federico Prefumo
      • Carate Brianza, Italy
        • Recruiting
        • Ospedale Vittorio Emanuele III
        • Contact:
          • Annalisa Inversetti
        • Principal Investigator:
          • Anna Locatelli
      • Cesena, Italy
        • Not yet recruiting
        • Ospedale M. Bufalini di Cesena
        • Contact:
          • Lucrezia Pignatti
        • Principal Investigator:
          • Patrizio Antonazzo
      • Desio, Italy
        • Not yet recruiting
        • Ospedale Desio
        • Contact:
          • Armando Pintucci
        • Principal Investigator:
          • Armando Pintucci
      • Lecco, Italy
        • Not yet recruiting
        • Ospedale Alessandro Manzoni
        • Contact:
          • Celia Callegari
        • Principal Investigator:
          • Antonio Pellegrino
      • MIlan, Italy
        • Not yet recruiting
        • Ospedale Niguarda
        • Contact:
          • Grazia Volpe
        • Principal Investigator:
          • Mario Giuseppe Meroni
      • Milan, Italy
        • Not yet recruiting
        • Ospedale dei Bambini "Vittore Buzzi"
        • Contact:
          • Elisa Fabbri
        • Contact:
          • Valentina Sala
        • Principal Investigator:
          • Irene Cetin
      • Milan, Italy
        • Not yet recruiting
        • Ospedale Mangiagalli
        • Contact:
          • Enrico Ferrazzi
        • Principal Investigator:
          • Enrico Ferrazzi
      • Milan, Italy
        • Not yet recruiting
        • Ospedale San Raffaele
        • Contact:
          • Luca Valsecchi
        • Principal Investigator:
          • Massimo Candiani
      • Milano, Italy
        • Not yet recruiting
        • Ospedale San Paolo
        • Contact:
          • Federica Lagrasta
        • Contact:
          • Cinzia Paolini
        • Principal Investigator:
          • Anna Maria Marconi
      • Milano, Italy
        • Not yet recruiting
        • Ospedale Macedonio Melloni
        • Contact:
          • Alice Guarano
        • Contact:
          • Giulia Dal Molin
        • Principal Investigator:
          • Michele Vignali
      • Modena, Italy
        • Not yet recruiting
        • Policlinico di Modena
        • Contact:
          • Giuseppe Chiossi
        • Principal Investigator:
          • Fabio Facchinetti
      • Monza, Italy
        • Recruiting
        • Obstetrics and Gynecology, MBBM Foundation at San Gerardo Hospital
        • Contact:
          • Alessandra Abbamondi
        • Contact:
        • Principal Investigator:
          • Sara Ornaghi
      • Rimini, Italy
        • Not yet recruiting
        • Ospedale Infermi di Rimini
        • Contact:
          • Lucrezia Pignatti
        • Principal Investigator:
          • Federico Spelzini
      • Varese, Italy
        • Not yet recruiting
        • Ospedale Filippo del Ponte
        • Contact:
          • Antonella Cromi
        • Principal Investigator:
          • Fabio Ghezzi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until the end of the study (approximately 54 months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until the end of the study (approximately 54 months).
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.
Until the end of the study (approximately 54 months).
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.
Until the end of the study (approximately 54 months).
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.
Until the end of the study (approximately 54 months).
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.
Until the end of the study (approximately 54 months).
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.
Until the end of the study (approximately 54 months).
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;
Until the end of the study (approximately 54 months).
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.
Until the end of the study (approximately 54 months).
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.
Until the end of the study (approximately 54 months).
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.
Until the end of the study (approximately 54 months).
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.
Until the end of the study (approximately 54 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Investigators

  • Principal Investigator: Sara Ornaghi, sara.ornaghi@unimib.it
  • Study Director: Patrizia Vergani, patrizia.vergani@unimib.it

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2020

Primary Completion (Estimated)

October 28, 2024

Study Completion (Estimated)

April 28, 2025

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MODEL-PLACENTA STUDY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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