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NCT06850974
Foley Balloon for Cervical Preparation Before Dilation and Evacuation
NA trial testing Foley Balloon Catheter in Abortion, Second Trimester in 102 participants. Currently enrolling.
1 March 2027
Quick facts
| Lead sponsor | Stony Brook University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 102 |
| Start date | 10 February 2025 |
| Primary completion | 1 March 2027 |
| Estimated completion | 1 March 2027 |
| Sites | 1 location across Mozambique |
Drugs / interventions tested
- Foley Balloon Catheter
- Misoprostol (Misoprostol) — full drug profile →
- Laminaria
Conditions studied
- Abortion, Second Trimester — all drugs for Abortion, Second Trimester →
- Abortion, Medical — all drugs for Abortion, Medical →
Sponsor
Stony Brook University
Who can join
18 and older, female only, with Abortion, Second Trimester or Abortion, Medical. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06850974
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06850974 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Stony Brook University
- Last refreshed: 26 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06850974.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing