Induction of Labor
Conditions
Brief summary
One of every four births in the Western world is induced, usually due to the risk of maternal and fetal morbidity. There are several methods of labor induction, pharmacological and mechanical. In cases of unfavorable cervix (Bishop score is below 5), cervical ripening can be induced by either prostaglandins E2 (slow release 10 mg dinoprostone insert (propess) or vaginal gel 1-2 mg) or mechanically by Foley catheter balloon (FCB). The efficacy of labor induction of propess versus vaginal gel combined with FCB was not studied previously. The goal of this randomized controlled trial is to compare the efficacy of propess versus PGE2 vaginal gel combined with FCB in women with singletons undergoing labor induction at term. The main question it aims to answer is to compare the time from the beginning of labor induction until delivery.
Interventions
DRUGDinoprostone vaginal insert
Described in the arm descriptions
COMBINATION_PRODUCTDinoprostone gel and Foley catheter balloon
Described in the arm descriptions
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant women at term (37 weeks of gestation or more) with singleton * pregnancies that are intended for IOL. * Initial bishop score \<5 * No contraindications to receive either treatment. * Women who will give informed consent to be included in the study. * Women at or over the age of 18.
Exclusion criteria
* Women with a known hypersensitivity or contraindications to Propess / PGE2. * Parity 5 or more * Labor contractions more than 4 in 20 min * Glaucoma * History of previous uterine surgery * Hypersensitivity to prostaglandins * Vaginal delivery is contraindicated * Active cardiac, renal, pulmonary, or hepatic disease * Severe asthma or pulmonary disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| comparing the duration of induction-to-vaginal delivery | from enrollment until final outcome - a month | measuring the duration of Induction-of-labor by Propess versus the combined use of PGE2 gel and balloon catheter by induction-to-vaginal delivery interval from the beginning of the induction according to the chosen patient protocol and until vaginal delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of vaginal delivery in 24 and 48 hours from IOL | from enrollment until final outcome - a month | the number of participants who had vaginal delivery in 24 and 48 hours from the beginning of the induction-of-labor for both protocols |
| Number of Participants with Treatment-Related Adverse Events | from enrollment until final outcome - a month | Maternal -gathering the numbers of participants who had adverse events such as chorioamnionitis, endometritis, postpartum hemorrhage, uterine rupture, Neonatal -gathering the numbers of participants who had adverse events such as uterine hypertonia (contractions exceeding more than two minutes in duration) and/or tachysystole (more than 5 contractions in 10 minutes, averaged over a 30-minute period) with and without decelerations, non-reassuring fetal heart rate according to fetal monitoring, meconium-stained amniotic liquor, umbilical artery pH less than 7.1, Apgar score less than 7 at 5 min, postpartum transfer to neonatal intensive care unit, infection of the newborn |
| rate of Induction success | from enrollment until final outcome - a month | the number of participants who had ceasarean section |
| rate o Cervical ripening success | from enrollment until final outcome - a month | the duration from the beginning of the induction to bishop score 5 |
Countries
Israel
Contacts
Primary ContactZohar Nachum, Professor
Outcome results
None listed