Induction of Labor
Conditions
Keywords
Induction of labor, Ripening, Single balloon catheter, Double balloon catheter
Brief summary
The purpose of this study is to compare between single balloon catheter and double balloon catheter for ripening the cervix among pregnant with unfavorable cervix.
Interventions
DEVICEFoley catheter
Single balloon catheter
DEVICEAtad catheter
Double balloon catheter
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
No
Inclusion criteria
* Induction of labor is indicated * Gestational age between 24 - 42 weeks * Singleton pregnancy * Bishop score less than 7
Exclusion criteria
* Any contraindication for vaginal delivery * Previous cesarean delivery * Low lying placenta * Rupture of membranes * Fetal malformations incompatible with life * intrauterine fetal death * Amnionitis * Genital viral infection (HIV, hepatitis C virus , hepatitis B virus) * Allergy to latex
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average Time in Hours From Insertion of the Catheter Until Delivery | At the end of the study |
Secondary
| Measure | Time frame |
|---|---|
| To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups | At the end of the study |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Balloon Catheter Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter) | 145 |
| Double Balloon Catheter Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter) | 148 |
| Total | 293 |
Baseline characteristics
| Characteristic | Single Balloon Catheter | Double Balloon Catheter | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 145 Participants | 148 Participants | 293 Participants |
| Region of Enrollment Israel | 145 participants | 148 participants | 293 participants |
| Sex: Female, Male Female | 145 Participants | 148 Participants | 293 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 145 | 0 / 148 |
| serious Total, serious adverse events | 0 / 145 | 0 / 148 |
Outcome results
Primary
Average Time in Hours From Insertion of the Catheter Until Delivery
Time frame: At the end of the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Balloon Catheter | Average Time in Hours From Insertion of the Catheter Until Delivery | 19.4 HOURS | Standard Deviation 6 |
| Double Balloon Catheter | Average Time in Hours From Insertion of the Catheter Until Delivery | 19.1 HOURS | Standard Deviation 6.8 |
Secondary
To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups
Time frame: At the end of the study