Clinical trial · Interventional
Misoprostol With And Without Transcervical Balloon Catheter In Second Trimester Termination Of Pregnancy
Misoprostol With And Without Transcervical Balloon Catheter In Second Trimester Termination Of Pregnancy: A Randomized Controlled Trial
NCT03106389CI-TRIAL-00027445unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized controlled study will be performed to compare the benefits and risks associated with the administration of misoprostol with or without the use of a transcervical balloon catheter to terminate pregnancy in the second trimester (defined as gestational age between 14 and 28 weeks of gestation).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abortion, Second Trimester | — | UNRESOLVED | — |
| Catheters | — | UNRESOLVED | — |
| Misoprostol | — | UNRESOLVED | — |
| Pregnancy Trimester, Second | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Misoprostol | Drug | — | UNRESOLVED |
| Misoprostol/Transcervical catheter | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Misoprostol
- description
- This group will receive 400 micrograms of misoprostol administered vaginally for the first dose, followed after 6 hours by 400 micrograms administered orally, repeated every 6 hours.
- interventionNames
- Drug: Misoprostol
- type
- EXPERIMENTAL
- label
- Misoprostol/Transcervical catheter
- description
- This group will receive the same regimen, but will have in addition a transcervical balloon (Foleys') catheter that is inflated with 30 ml. of fluid; with weighted traction using a 1000 ml fluid-filled bag applying continuous pressure to the cervix
- interventionNames
- Drug: Misoprostol
- Device: Misoprostol/Transcervical catheter
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: pregnancy in the second trimester (defined as gestational age between 14 and 28 weeks of gestation) with a medical indication for termination of pregnancy. \- Exclusion Criteria: \-
References
Publications (0)
Data not yet available
No reference posted for this study.