Foley Balloon for Cervical Preparation Before Dilation and Evacuation
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
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
Treatments tested in this trial
- Foley Balloon Catheter
- Misoprostol
- Laminaria
Treatment groups
102 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov