Health Trials

Foley Balloon for Cervical Preparation Before Dilation and Evacuation

ConditionsAbortion, Second TrimesterAbortion, Medical
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorStony Brook University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women 18 years and older presenting to Hospital Central de Maputo requiring abortion for any legal indication between 16-21 weeks gestation.

Portuguese speaking

Disqualifiers

Less than age 18

Incarcerated

Chorioamnionitis

Active heavy bleeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Foley Balloon Catheter

    Device

    18 French Foley Balloon placed trans-cervically and inflated with 30-60ml of Normal Saline.

  • Misoprostol

    Drug

    400 mcg of buccal misoprostol sublingual

  • Laminaria

    Device

    Laminaria will be placed in the cervix according to the following standard formula: Estimated gestational age -10 = number of 5mm laminaria.

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Foley Balloon and misoprostolExperimental treatment 2 interventions
Group B: LaminariaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total Procedure Time (TPT)

Determine if Foley Balloon arm (misoprostol and foley balloon) is different to Laminaria arm (Laminaria only) in changing Total Procedure Time (TPT) of dilation and evacuation (D\&E) procedure.

Time frame
through completion of D&E, approximately 15-20 minutes

Secondary outcomes

1

D&E operative time (OT)

Determine if Foley Balloon arm (misoprostol and foley balloon) is different to Laminaria arm (Laminaria only) in changing D\&E operative time (OT) of dilation and evacuation (D\&E) procedure.

Time frame
through completion of D&E, approximately 15-20 minutes
2

Initial pre-operative cervical dilation

Determine if Foley Balloon arm (misoprostol and foley balloon) is different to Laminaria arm (Laminaria only) in changing the initial pre-operative cervical dilation during the dilation and evacuation (D\&E) procedure.

Time frame
through completion of D&E, approximately 15-20 minutes
3

Potential Complications

Determine any potential same day complication rates between the foley balloon arm (foley balloon and misoprostol) versus the laminaria arm (laminaria only).

Time frame
through completion of the D&E, an average of 1-2 days
4

Visual Analogue Pain Scale

Determine if Foley Balloon arm (misoprostol and foley balloon) is different to Laminaria arm (Laminaria only) in changing the pain rating before and after dilation and evacuation (D\&E) procedure. Patient will complete a short survey, the Visual Analogue Pain Scale to rate their pain. The Minimum value of 0 and Maximum value of 10 where the higher value indicates more pain or worse outcome.

Time frame
through completion of the D&E, an average of 1-2 days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stony Brook University

Lead sponsor

Source ClinicalTrials.gov
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