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Evaluating birth methods for women with low-lying placenta

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

Observational University of Milano Bicocca · NCT04827433

This study is testing whether women with a low-lying placenta can safely have vaginal births if their placenta is far enough away from the cervix, to help improve delivery options.

Quick facts

Study typeObservational
Enrollment2550 (estimated)
Ages18 Years and up
SexFemale
SponsorUniversity of Milano Bicocca Academic / other
Locations17 sites (Bergamo and 16 other locations)
Trial IDNCT04827433 on ClinicalTrials.gov

What this trial studies

This multicenter observational study aims to assess the mode of delivery in women diagnosed with a low-lying placenta. It focuses on proposing vaginal birth for women with an internal-os-distance (IOD) greater than 5 mm, as determined by transvaginal sonography in the late third trimester. Participants will be recruited from those with confirmed low-lying placenta or placenta previa, and the study will follow them over a period of 54 months, including 42 months for enrollment and 6 months for data analysis.

Who should consider this trial

Good fit: Ideal candidates include women aged 18 and older with a confirmed diagnosis of low-lying placenta or placenta previa during the second trimester.

Not a fit: Patients with invasive placentation or those requiring emergency delivery due to vaginal bleeding will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence supporting safe vaginal deliveries for women with low-lying placenta, potentially reducing the need for cesarean sections.

How similar studies have performed: While similar studies have explored modes of delivery in cases of placenta previa, this specific approach focusing on low-lying placenta with defined IOD measurements is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Bergamo and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Low-LyingPlacenta, Hemorrhage, Complicating Deliverylow-lying placentamode of birthlabor and birth
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.