Mode of Delivery in Women With Low-lying Placenta

Launched by UNIVERSITY OF MILANO BICOCCA · Mar 29, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the best way to deliver babies for women who have a low-lying placenta or placenta previa, which is when the placenta is positioned too close to or over the cervix. The trial is looking for women aged 18 and older who are pregnant and have been diagnosed with either of these conditions through an ultrasound. The researchers want to understand how different delivery methods might affect outcomes for both mothers and babies. Women with a normally placed placenta will also be included as a comparison group.

If you decide to participate, you'll be asked to sign consent to join the study. You'll be monitored over time, and if you have any vaginal bleeding before 32 weeks of pregnancy but do not need an emergency delivery, you may be eligible. The study is currently recruiting participants, and being part of this research could help improve care for future mothers facing similar pregnancy issues.

Gender

FEMALE

Eligibility 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