Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Recruiting
N/A
Interventional Study
Abortion, Second Trimester
Abortion, Medical
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 102 (estimated)
- Sponsor
- Stony Brook University · Other
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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 osmoti…
Trial Locations
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Eligibility Criteria
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 bleed…
Contacts