BridgeMD
New treatment option for Abortion, Second Trimester
Official title Foley Balloon for Cervical Preparation Before Dilation and Evacuation
ClinicalTrials.gov ID: NCT06850974
What this study is testing
What is Misoprostol?
Misoprostol is an investigational medicine, being studied as a potential treatment for abortion, second trimester.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Women 18 years and older presenting to Hospital Central de Maputo requiring abortion for any legal indication between 16-21 weeks gestation.
- Portuguese speaking
You likely can't join if
- Less than age 18
- Incarcerated
- Chorioamnionitis
- Active heavy bleeding
- A known bleeding diathesis
- Hemodynamic instability
See the full eligibility 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
- Less than age 18
- Incarcerated
- Chorioamnionitis
- Active heavy bleeding
- A known bleeding diathesis
- Hemodynamic instability
- \> 2 cm dilation
- History of cervical cerclage
- Allergy to any study medications
- Eclampsia
- Glasgow Coma Score Less than 15
The study team makes the final eligibility decision.
Where it's taking place
- Maputo, Mozambique
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Maputo, Mozambique. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.