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Foley Balloon for Cervical Preparation Before Dilation and Evacuation

RecruitingNAAges 18 Years - anyFemaleStony Brook University
NCT06850974 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

To evaluate the Foley Balloon technique for cervical preparation before second trimester surgical abortion between 16 and 21 weeks estimated gestational age in combination with misoprostol to prepare the cervix before dilation and evacuation (D\&E) instead of osmotic dilators (Laminaria). Specific Aim One: Assess definitively whether using a Foley Balloon and Misoprostol is non-inferior to osmotic dilators for cervical preparation before D\&E. Specific Aim Two: Evaluate patient satisfaction with the two methods of second trimester abortion. Specific Aim Three: Evaluate provider satisfaction with the two methods of second trimester abortion.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Women 18 years and older presenting to Hospital Central de Maputo requiring abortion for any legal indication between 16-21 weeks gestation. * Portuguese speaking Exclusion Criteria: * Less than age 18 * Incarcerated * Chorioamnionitis * Active heavy bleeding * A known bleeding diathesis * Hemodynamic instability * \> 2 cm dilation * History of cervical cerclage * Allergy to any study medications * Eclampsia * Glasgow Coma Score Less than 15
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What it tests

  • Foley Balloon Catheter
  • Misoprostol
  • Laminaria
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Where

1 site
Hospital Central De Maputo
Maputo, Mozambique
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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