Abortion, Second TrimesterNCT06850974
Foley Balloon for Cervical Preparation Before Dilation and Evacuation
A study testing Foley Balloon Catheter, Misoprostol and Laminaria in people with Abortion, Second Trimester and Abortion, Medical, run by Stony Brook University at 1 site in Mozambique.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abortion, Second Trimester, Abortion, Medical
- What is being tested?
- Foley Balloon Catheter, Misoprostol and Laminaria
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteMozambique
- Study dates
- 10 Feb 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18 years and older presenting to Hospital Central de Maputo requiring abortion for any legal indication between 16-21 weeks gestation.
- Portuguese speaking
Who cannot join
- Less than age 18
- Incarcerated
- Chorioamnionitis
- Active heavy bleeding
- A known bleeding diathesis
- Hemodynamic instability
Show all 11Show fewer
- > 2 cm dilation
- History of cervical cerclage
- Allergy to any study medications
- Eclampsia
- Glasgow Coma Score Less than 15
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mozambique1 site, 1 recruiting
- Recruiting
Hospital Central De Maputo
Maputo
Sibone Mocumbi, MD PhD, +258 843250540, sibone@yahoo.com
Sierra Washington, MD Msc, +258 841477208, sierra.washington@stonybrook.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Abortion, Second Trimester, Abortion, Medical
- Being tested
- Foley Balloon Catheter, Misoprostol, Laminaria
- Keywords
- second, trimester, abortion, surgical, balloon, Foley
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley Balloon CatheterDevice
18 French Foley Balloon placed trans-cervically and inflated with 30-60ml of Normal Saline.
MisoprostolDrug
400 mcg of buccal misoprostol sublingual
LaminariaDevice
Laminaria will be placed in the cervix according to the following standard formula: Estimated gestational age -10 = number of 5mm laminaria.
| Study group | Role | What they receive |
|---|---|---|
| Foley Balloon and misoprostol | Experimental | Patients in the Foley Balloon arm will have a Foley balloon catheter placed trans-cervically and also receive misoprostol per protocol Receives: Device: Foley Balloon Catheter; Drug: Misoprostol |
| Laminaria | Active comparator | Patients in the Laminaria arm will have a Laminaria placed in the cervix and it will be left in situ per protocol Receives: Device: Laminaria |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through completion of D&E, approximately 15-20 minutes
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through completion of the D&E, an average of 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start10 Feb 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, Second TrimesterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single blind randomized controlled trial
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sierra Washington, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850974
- Sponsor's protocol ID
- IRB2023-00297
- Other IDs
- stony brook university
- Status last verified
- Apr 2026
- First submitted
- 11 Feb 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: de-identifed patient database will be shared
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foley Balloon for Cervical Preparation Before Dilation and Evacuation
- ClinicalTrials.gov ID
- NCT06850974
- Acronym / sponsor ID
- IRB2023-00297
- Conditions
- Abortion, Second Trimester, Abortion, Medical
- Keywords
- second, trimester, abortion, surgical, balloon, Foley
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- single blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Foley Balloon and misoprostol | Experimental | Device: Foley Balloon Catheter, Drug: MisoprostolPatients in the Foley Balloon arm will have a Foley balloon catheter placed trans-cervically and also receive misoprostol per protocol |
| Laminaria | Active comparator | Device: LaminariaPatients in the Laminaria arm will have a Laminaria placed in the cervix and it will be left in situ per protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women 18 years and older presenting to Hospital Central de Maputo requiring abortion for any legal indication between 16-21 weeks gestation.
- Portuguese speaking
Key exclusion criteria (11 listed)
- Less than age 18
- Incarcerated
- Chorioamnionitis
- Active heavy bleeding
- A known bleeding diathesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foley Balloon Catheter18 French Foley Balloon placed trans-cervically and inflated with 30-60ml of Normal Saline. | Device | Foley Balloon and misoprostol |
| Misoprostol400 mcg of buccal misoprostol sublingual | Drug | Foley Balloon and misoprostol |
| LaminariaLaminaria will be placed in the cervix according to the following standard formula: Estimated gestational age -10 = number of 5mm laminaria. | Device | Laminaria |
Primary outcome
Total Procedure Time (TPT)
Time frame: through completion of D&E, approximately 15-20 minutes
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.
6 secondary outcomes
D&E operative time (OT)
Time frame: through completion of D&E, approximately 15-20 minutes
Initial pre-operative cervical dilation
Time frame: through completion of D&E, approximately 15-20 minutes
Potential Complications
Time frame: through completion of the D&E, an average of 1-2 days
Visual Analogue Pain Scale
Time frame: through completion of the D&E, an average of 1-2 days.
Provider Satisfaction Questionnaire
Time frame: through study completion, an average of 1-2 days
Patient Satisfaction Questionnaire
Time frame: through completion of the D&E, an average of 1-2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Yes. de-identifed patient database will be shared
Related trials for Abortion, Second Trimester
Not yet recruitingPhase 1/2
Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone
Abortion Induced Complicated, Abortion
RecruitingPhase 2
Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement
Pain Management, Abortion
Recruiting
Cervical Preparation for Same-Day Dilation & Evacuation
Abortion, Second Trimester, Procedural Pain
RecruitingPhase 4
Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes
Abortion, Dilation and Evacuation
Not yet recruitingObservational study
Misoprostol in Missed Abortion
Abortion; Attempted
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foley Balloon Catheter, Misoprostol and Laminaria in people with Abortion, Second Trimester and Abortion, Medical, run by Stony Brook University at 1 site in Mozambique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sierra Washington, MD MSc (+258 84 147 7208, sierra.washington@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Procedure Time (TPT) (time frame: through completion of D&E, approximately 15-20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.