Clinical trial · Interventional
Foley Balloon for Cervical Preparation Before Dilation and Evacuation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abortion, Medical | — | UNRESOLVED | — |
| Abortion, Second Trimester | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Foley Balloon Catheter | Device | — | UNRESOLVED |
| Laminaria | Device | — | UNRESOLVED |
| Misoprostol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Foley Balloon and misoprostol
- description
- Patients in the Foley Balloon arm will have a Foley balloon catheter placed trans-cervically and also receive misoprostol per protocol
- interventionNames
- Device: Foley Balloon Catheter
- Drug: Misoprostol
- type
- ACTIVE_COMPARATOR
- label
- Laminaria
- description
- Patients in the Laminaria arm will have a Laminaria placed in the cervix and it will be left in situ per protocol
- interventionNames
- Device: Laminaria
Primary outcomes (1)
- measure
- Total Procedure Time (TPT)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available