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Low-Lying; Placenta, Hemorrhage, Complicating DeliveryMODEL-PLACENTANCT04827433

Mode of Delivery in Women With Low-lying Placenta

An observational study of Low-Lying; Placenta, Hemorrhage, Complicating Delivery, run by University of Milano Bicocca at 17 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Multicentre study; observational, longitudinal prospective, case-control Read more about this study

Who is it for?
Ages 18 years and older, women only
How many people
2,550 participants
Where
17 sitesItaly
Study dates
28 Oct 2020to 28 Apr 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

17 sites in 1 country.

Elisabetta Colciago contact

0392332657

elisabetta.colciago@gmail.com

Isadora Vaglio Tessitore contact

0392332657

i.vagliotessitore@campus.unimib.it

17 sites in 1 country

Italy17 sites, 17 recruiting

  • Ospedale Papa Giovanni XXIII

    Bergamo

    Luisa Patane'

    Luigi Frigerio

    Not yet recruiting

  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia

    Edoardo Barbolini

    Anna Catalano

    Recruiting

  • Ospedale Spedali Civili

    Brescia

    Cristina Zanardini

    Valentina Parolin

    Not yet recruiting

  • Ospedale Vittorio Emanuele III

    Carate Brianza

    Annalisa Inversetti

    Anna Locatelli

    Recruiting

  • Ospedale M. Bufalini di Cesena

    Cesena

    Lucrezia Pignatti

    Patrizio Antonazzo

    Not yet recruiting

  • Ospedale Desio

    Desio

    Armando Pintucci

    Armando Pintucci

    Not yet recruiting

  • Ospedale Alessandro Manzoni

    Lecco

    Celia Callegari

    Antonio Pellegrino

    Not yet recruiting

  • Ospedale dei Bambini "Vittore Buzzi"

    Milan

    Elisa Fabbri

    Valentina Sala

    Not yet recruiting

  • Ospedale Mangiagalli

    Milan

    Enrico Ferrazzi

    Enrico Ferrazzi

    Not yet recruiting

  • Ospedale Niguarda

    Milan

    Grazia Volpe

    Mario Giuseppe Meroni

    Not yet recruiting

  • Ospedale San Raffaele

    Milan

    Luca Valsecchi

    Massimo Candiani

    Not yet recruiting

  • Ospedale Macedonio Melloni

    Milan

    Alice Guarano

    Giulia Dal Molin

    Not yet recruiting

  • Ospedale San Paolo

    Milan

    Federica Lagrasta

    Cinzia Paolini

    Not yet recruiting

  • Policlinico di Modena

    Modena

    Giuseppe Chiossi

    Fabio Facchinetti

    Not yet recruiting

  • Obstetrics and Gynecology, MBBM Foundation at San Gerardo Hospital

    Monza

    Alessandra Abbamondi

    Isadora VaglioTessitore, 3343200574, i.vagliotessitore@campus.unimib.it

    Recruiting

  • Ospedale Infermi di Rimini

    Rimini

    Lucrezia Pignatti

    Federico Spelzini

    Not yet recruiting

  • Ospedale Filippo Del Ponte

    Varese

    Antonella Cromi

    Fabio Ghezzi

    Not yet recruiting

Other trials in Italy

About this study

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

Multicentre study; observational, longitudinal prospective, case-control

Read the 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.

Keywords
low-lying placenta, mode of birth, labor and birth
Medical subject headings
Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04827433
Study groupRoleWhat they receive
Women having a persistent low-lying placenta with an IOD between 6 and 20 mmWomen 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 placentaWomen with a normally located placenta at the II trimester scan will represent the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of vaginal delivery and urgent cesarean section

    Rate of vaginal birth and emergency cesarean section in labor due to vaginal bleeding

    Measured: Until the end of the study (approximately 54 months).

Secondary outcomes (11)

  1. Frequency of resolution of placenta previa or low-lying

    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

    Measured: Until the end of the study (approximately 54 months).

  2. Placental migration speed and its correlation with different variables

    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.

    Measured: Until the end of the study (approximately 54 months).

  3. Frequency of ultrasound visualization of the marginal breast in low-lying placentas and other variables

    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.

    Measured: Until the end of the study (approximately 54 months).

  4. Refusal of elective caesarean section

    Rate of women declining the mode of birth suggested by clinicians during counselling.

    Measured: Until the end of the study (approximately 54 months).

  5. Morbidity associated with the various groups of placental distance analyzed by the antepartum hemorrhage incidence.

    Incidence of antepartum hemorrhage requiring hospital admission or immediate delivery.

    Measured: Until the end of the study (approximately 54 months).

  6. Morbidity associated with the various groups of placental distance studied with the intrapartum hemorrhage incidence.

    Incidence of intrapartum hemorrhage requiring emergency CS.

    Measured: Until the end of the study (approximately 54 months).

  7. Morbidity associated with the various groups of placental distance through the severe postpartum hemorrhage incidence.

    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;

    Measured: Until the end of the study (approximately 54 months).

  8. Morbidity associated with the various groups of placental distance associated with the admission to Intensive Care Unit (ICU)

    The maternal admission to ICU.

    Measured: Until the end of the study (approximately 54 months).

  9. Morbidity associated with the various groups of placental distance described by the preterm bith incidence

    Incidence of preterm birth can described the morbidity associated wiith the various groups of placenta distance.

    Measured: Until the end of the study (approximately 54 months).

  10. Morbidity associated with the various groups of placental distance described through the preterm incidence less than 32 weeks.

    Incidence of preterm birth < 32 weeks.

    Measured: Until the end of the study (approximately 54 months).

  11. Morbidity associated with the various groups of placental distance according to the neonatal admission to ICU

    Neonatal admission to Neonatal ICU and length of stay.

    Measured: Until the end of the study (approximately 54 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2021
  2. Study start28 Oct 2020
  3. Primary completion28 Oct 2024 (estimated)
  4. Study completion28 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
2,550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04827433
Sponsor's protocol ID
MODEL-PLACENTA STUDY
Acronym
MODEL-PLACENTA
Status last verified
Dec 2023
First submitted
22 Mar 2021
Last updated
2 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Committee on Obstetric Practice. Committee Opinion No. 713: Antenatal Corticosteroid Therapy for Fetal Maturation. Obstet Gynecol. 2017 Aug;130(2):e102-e109. doi: 10.1097/AOG.0000000000002237.

    PubMed 28742678

  • ACOG Committee Opinion No. 764: Medically Indicated Late-Preterm and Early-Term Deliveries. Obstet Gynecol. 2019 Feb;133(2):e151-e155. doi: 10.1097/AOG.0000000000003083.

    PubMed 30681545

  • Al Wadi K, Schneider C, Burym C, Reid G, Hunt J, Menticoglou S. Evaluating the safety of labour in women with a placental edge 11 to 20 mm from the internal cervical Os. J Obstet Gynaecol Can. 2014 Aug;36(8):674-677. doi: 10.1016/S1701-2163(15)30508-9.

    PubMed 25222161

  • Blackwell SC. Timing of delivery for women with stable placenta previa. Semin Perinatol. 2011 Oct;35(5):249-51. doi: 10.1053/j.semperi.2011.05.004.

    PubMed 21962622

  • Bhide A, Prefumo F, Moore J, Hollis B, Thilaganathan B. Placental edge to internal os distance in the late third trimester and mode of delivery in placenta praevia. BJOG. 2003 Sep;110(9):860-4.

    PubMed 14511970

  • Alouini S, Megier P, Fauconnier A, Huchon C, Fievet A, Ramos A, Megier C, Valery A. Diagnosis and management of placenta previa and low placental implantation. J Matern Fetal Neonatal Med. 2020 Oct;33(19):3221-3226. doi: 10.1080/14767058.2019.1570118. Epub 2019 Jan 27.

    PubMed 30688129

  • Dashe JS. Toward consistent terminology of placental location. Semin Perinatol. 2013 Oct;37(5):375-9. doi: 10.1053/j.semperi.2013.06.017.

    PubMed 24176163

  • Farine D, Fox HE, Jakobson S, Timor-Tritsch IE. Vaginal ultrasound for diagnosis of placenta previa. Am J Obstet Gynecol. 1988 Sep;159(3):566-9. doi: 10.1016/s0002-9378(88)80009-7.

    PubMed 3048096

  • Bronsteen R, Valice R, Lee W, Blackwell S, Balasubramaniam M, Comstock C. Effect of a low-lying placenta on delivery outcome. Ultrasound Obstet Gynecol. 2009 Feb;33(2):204-8. doi: 10.1002/uog.6304.

    PubMed 19173234

  • Ginsberg Y, Goldstein I, Lowenstein L, Weiner Z. Measurements of the lower uterine segment during gestation. J Clin Ultrasound. 2013 May;41(4):214-7. doi: 10.1002/jcu.22023. Epub 2013 Mar 16.

    PubMed 23505018

  • Fukuda M, Fukuda K, Shimizu T, Bujold E. Ultrasound Assessment of Lower Uterine Segment Thickness During Pregnancy, Labour, and the Postpartum Period. J Obstet Gynaecol Can. 2016 Feb;38(2):134-40. doi: 10.1016/j.jogc.2015.12.009. Epub 2016 Mar 2.

    PubMed 27032737

  • Jansen C, de Mooij YM, Blomaard CM, Derks JB, van Leeuwen E, Limpens J, Schuit E, Mol BW, Pajkrt E. Vaginal delivery in women with a low-lying placenta: a systematic review and meta-analysis. BJOG. 2019 Aug;126(9):1118-1126. doi: 10.1111/1471-0528.15622. Epub 2019 Mar 10.

    PubMed 30663270

  • Nakamura M, Hasegawa J, Matsuaka R, Mimura T, Ichizuka K, Sekizawa A, Okai T. Amount of hemorrhage during vaginal delivery correlates with length from placental edge to external os in cases with low-lying placenta whose length between placental edge and internal os was 1-2 cm. J Obstet Gynaecol Res. 2012 Aug;38(8):1041-5. doi: 10.1111/j.1447-0756.2011.01776.x. Epub 2012 May 21.

    PubMed 22612540

  • Ohira S, Kikuchi N, Kobara H, Osada R, Ashida T, Kanai M, Shiozawa T. Predicting the route of delivery in women with low-lying placenta using transvaginal ultrasonography: significance of placental migration and marginal sinus. Gynecol Obstet Invest. 2012;73(3):217-22. doi: 10.1159/000333309. Epub 2012 Mar 1.

    PubMed 22378482

  • Jauniaux E, Alfirevic Z, Bhide AG, Belfort MA, Burton GJ, Collins SL, Dornan S, Jurkovic D, Kayem G, Kingdom J, Silver R, Sentilhes L; Royal College of Obstetricians and Gynaecologists. Placenta Praevia and Placenta Accreta: Diagnosis and Management: Green-top Guideline No. 27a. BJOG. 2019 Jan;126(1):e1-e48. doi: 10.1111/1471-0528.15306. Epub 2018 Sep 27. No abstract available.

    PubMed 30260097

Questions about this trial

What is this clinical trial studying?

An observational study of Low-Lying; Placenta, Hemorrhage, Complicating Delivery, run by University of Milano Bicocca at 17 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Elisabetta Colciago (0392332657, elisabetta.colciago@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of vaginal delivery and urgent cesarean section (time frame: Until the end of the study (approximately 54 months).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04827433, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.

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