Health TrialsbyHealthPanel

Cervical Ripening Balloons for Same-Day Cervical Prep

ConditionDilation and Evacuation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of New Mexico

About this trial

The goal of this clinical trial is to learn if a cervical ripening balloon (Foley balloon) works to prepare the cervix before same-day outpatient dilation and evacuation (D\&E). The main questions it aims to answer are:

* Is cervical preparation with cervical ripening balloon for same-day outpatient D\&E non-inferior to cervical preparation with osmotic dilators? * How feasible and safe is cervical preparation with cervical ripening balloon for same-day outpatient D\&E? * How acceptable is cervical preparation with cervical ripening balloon for same-day outpatient D\&E?

Participants will:

* Have cervical preparation with cervical ripening balloon (experimental group) or osmotic dilators (usual care group) * Complete two surveys, one about the cervical preparation and one about the D\&E procedure

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals who desire outpatient dilation and evacuation (D&E)

At least 18 years of age

Able and willing to consent

Gestational duration between 18 weeks 0 days and 19 weeks 6 days as determined by ultrasound

Disqualifiers

Medical conditions that require procedural management in the operating room

Preference for D&E procedure in the operating room

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cervical Ripening Balloon

    Device

    30 milliliter Foley balloon

  • Osmotic Dilators

    Device

    Dilapan-S

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Cervical Ripening BalloonExperimental treatment 1 intervention
Group B: Osmotic DilatorsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

D&E procedure length (minutes)

From insertion of first instrument to removal of speculum

Time frame
during procedure

Secondary outcomes

1

Starting dilation (French gauge)

Pratt dilator size in French gauge (sequential numbered instruments with size corresponding to diameter)

Time frame
during procedure
2

Additional dilation (French gauge)

Pratt dilator size in French gauge (sequential numbered instruments with size corresponding to diameter)

Time frame
during procedure
3

Estimated blood loss (milliliters)

Amount of blood loss, measured in milliliters throughout the procedure

Time frame
during procedure
4

Additional sedation medication administered

yes/no

Time frame
during procedure

Other outcomes

Sponsors and contacts

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

University of New Mexico

Lead sponsor

Source ClinicalTrials.gov
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