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Tests treatment safety and results for Induction of Labor
Official title Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP)
ClinicalTrials.gov ID: NCT07414771
What this study is testing
- What it's testing
- The goal of this clinical study is to evaluate a new mechanical balloon catheter (INGA) used to prepare the cervix for labor induction in pregnant women at term. The study aims to assess the safety, usability, and performance of the INGA catheter when used for cervical ripening before labor.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 56, women only
You may be able to join if
- Pregnant women aged ≥18 and ≤56 years
- An unripe cervix, ≤6 points according to the Bishop assessment (0-10 point scale)
- Planned induction of labor by mechanical balloon catheter method
- Examples of diagnoses as the basis for labor induction:
- Post-term pregnancy (≥41 weeks of gestation)
You likely can't join if
- Preterm induction of labor (\<37 weeks of gestation)
- Pathological CTG at inclusion
- Spontaneous rupture of membranes at inclusion
- Clinically significant vaginal bleeding with need of hospitalization in the third trimester
- Clinically active vaginal or uterine infection
- Maternal HIV, hepatitis C, or hepatitis B
See the full eligibility criteria
- Pregnant women aged ≥18 and ≤56 years
- An unripe cervix, ≤6 points according to the Bishop assessment (0-10 point scale)
- Planned induction of labor by mechanical balloon catheter method
- Examples of diagnoses as the basis for labor induction:
- Post-term pregnancy (≥41 weeks of gestation)
- Maternal request for labor induction
- Gestational diabetes
- Preeclampsia (with blood pressure \<150/100)
- Well-controlled hypertension
- Cholestasis of pregnancy
- Humanitarian or psychosocial reasons
- Gestational age at the time of the study ≥ 37 weeks (gestational age confirmed by ultrasound before the 21st week of pregnancy)
- Singleton pregnancy
- Cephalic presentation
- The subject understands the study information and signs the consent form
- Preterm induction of labor (\<37 weeks of gestation)
- Pathological CTG at inclusion
- Spontaneous rupture of membranes at inclusion
- Clinically significant vaginal bleeding with need of hospitalization in the third trimester
- Clinically active vaginal or uterine infection
- Maternal HIV, hepatitis C, or hepatitis B
- Uterine scar (including previous cesarean section)
- Condition of the fetus or mother requiring immediate delivery
- Presence of eclampsia
- Severe Pre-eclampsia (Blood pressure ≥160/110 and any of the following: low platelet count (\<100 × 10 9/L), HELLP, progressive renal insufficiency, pulmonary edema)
- Severe fetal growth restriction (FGR, fetal growth \< -2 SD)
- Estimated fetal weight ≥ 2SD or ≥ 95th percentile
- Breech or transverse fetal position
- Multiple pregnancy
- Vasa previa or placenta previa
- Umbilical cord prolapse
- Maternal refusal to participate in the study and/or insufficient language skills to understand the study information and/or consent form
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, HUS, Finland
- Jyväskylä, Finland
- Tampere, Finland
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 to 56 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, HUS, Finland; Jyväskylä, Finland; Tampere, Finland. 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.