An interventional study of Foley Balloon Catheter and Misoprostol in Abortion, Second Trimester and Abortion, Medical, sponsored by Stony Brook University. Recruiting at 1 site in Mozambique. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Stony Brook University · Not applicable, Interventional, and Treatment
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.
Termination of pregnancy was legalized in Mozambique in 2016 for any reason until 12 weeks, and up 16 weeks in cases of rape, and at any time for cases of fetal demise, severe fetal anomaly, or to protect a woman's physical or mental health. It is also legal up until 24 weeks in the case of a chronic infectious or degenerative disease. Termination of pregnancy can be accomplished either by induction of labor or by Dilation and Evacuation (D\&E). Typically, D\&E after 16 weeks is a two-day procedure. The first day is devoted to cervical preparation, where osmotic dilators are placed into the cervix and allowed to slowly soften and dilate the cervix. On the second day of the procedure the uterus is evacuated. Osmotic dilators are expensive and unavailable in most of Sub-Saharan Africa. An alternative strategy to cervical preparation has recently been developed by Dr. Yashica Robinson and has been described in a retrospective cohort study. This new technique involves using a Foley Catheter balloon (FB) inserted into the cervix to dilate the cervix over several hours with buccal misoprostol as an adjunct medication. After which, the procedure is completed using the dilation and evacuation procedure. However, Foley Balloon for cervical preparation before dilation and evacuation is still considered investigational. Both Foley Balloon and misoprostol are low cost and widely available in Africa and thus may be a safe and efficacious alternative to osmotic dilators. These two strategies of cervical preparation have never been directly compared in a prospective randomized clinical trial. This study aims to conduct a randomized controlled trial to evaluate the Foley Balloon for cervical preparation before D\&E. Specifically, our objective is to evaluate the Foley Balloon technique for cervical preparation before second trimester surgical abortion between 16 and 21 weeks estimated gestational age. The investigators propose to conduct a randomized controlled non-inferiority trial to compare procedure difficulty, complication rates, provider satisfaction, and patient satisfaction with a novel technique to prove that the Foley Balloon and misoprostol method is safe, effective, and acceptable to providers and patients.
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Exclusion Criteria:
Patients in the Foley Balloon arm will have a Foley balloon catheter placed trans-cervically and also receive misoprostol per protocol
Device: Foley Balloon Catheter · Drug: Misoprostol
Patients in the Laminaria arm will have a Laminaria placed in the cervix and it will be left in situ per protocol
Device: Laminaria
18 French Foley Balloon placed trans-cervically and inflated with 30-60ml of Normal Saline.
400 mcg of buccal misoprostol sublingual
Laminaria will be placed in the cervix according to the following standard formula: Estimated gestational age -10 = number of 5mm laminaria.
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
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
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
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
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.
Provider Satisfaction Questionnaire
Providers will describe satisfaction by responding to questionnaire regarding cervical preparation.
Time frame: through study completion, an average of 1-2 days
Patient Satisfaction Questionnaire
Patients will describe satisfaction by responding to questionnaire regarding satisfaction with the cervical preparation procedure.
Time frame: through completion of the D&E, an average of 1-2 days
Plan to share: Yes — de-identifed patient database will be shared
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 1/2026-1/2046
Access criteria: Independent validated investigators, peer reviewed journal editors will be able to access the study protocol, the data analysis plan and the de-identified database should they wish to perform a meta- analysis.
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Studies of the drug tested here: Misoprostol