Pregnancy Related
Conditions
Keywords
induction of labor, unfavorable cervix, misoprostol, cytotec, double balloon device, cervical ripening
Brief summary
The aim of this study is to compare the rate of cesarean delivery between 3 methods of labor induction: double balloon device, oral misoprostol and combination of the two.
Detailed description
Induction of labor is a common obstetrical procedure. It accounts for 20% of laboring women worldwide. In the past, studies showed that cesarean delivery rates (CDR) are higher in women who are induced. These studies were comparing induction to spontaneous labor, which is not the management in practice, and when the comparison was made between induction and expectant management, the conclusion was that the induction does not increase CDR and can even reduce its' rate. Failure of induction depends on the definition, and even among randomized controlled trials, this definition may vary greatly. The decision whether to use a mechanical or pharmacological agent depends on Bishop score, parity, contraindications to one of the methods and patient-doctor preference. Recently, more data are available regarding induction with oral misoprostol (OM) and this method is becoming more popular because OM is effective, safe, convenient, cheap and easy to administer. If mechanical induction is preferable, either single or double balloon device (DBD) can be used. These methods have been previously studied and neither found to be superior. A recent study showed that, insertion of the DBD for 6 hours in nulliparous women, results in shorter time to delivery (26 hours vs. 31.4 hours, p=0.015), similar Bishop score after removal ( 5.74 vs. 5.26, p=0.2) without increasing the rate of cesarean deliveries (19% vs 32%, p=0.135) when compared to insertion of the DBD for 12 hours as instructed by the manufacturer. Several studies have shown that a combination of pharmacological and single balloon device results in higher rates to achieve vaginal delivery when compared to each method separately The investigators hypothesize that with the combination of DBD for 6 hours and OM we will be able to reduce the rate of cesarean deliveries when compared to each method separately. To date, there are no studies that compared double balloon device with oral misoprostol used concomitantly.
Interventions
50 mcg oral consumption
DEVICEdouble balloon device for cervical ripening
insertion for 6 hours and followed by the above mentioned protocol
Sponsors
Bnai Zion Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* unfavourable cervix (Bishop score ≤ 4), * indication for induction of labor (medical or obstetrical), * 37 completed gestational weeks, * vertex presentation, * singleton pregnancy * intact membranes.
Exclusion criteria
* previous cesarean delivery * previous uterine surgery (eg: myomectomy) * noncephalic presentation * multiple pregnancy * pre-eclampsia with severe features * oligohydramnios (Maximal vertical pocket ≤2) * estimated fetal weight \<10% percentile * any contraindication to Vaginal delivery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rate of cesarean delivery | from induction until delivery | percentage of cesarean delivery from all deliveries |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bishop score difference between groups | after 6 hours and after 24 hours | cervical change evaluation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of achieving active phase of labor (≥ 5 cm cervical dilatation) | within 24 hours of initiation | how many women had more than 5 cm cervical dilatation |
| Cesarean delivery indication (non progressive labor or non reassuring fetal heart rate NRFHR) | from initiation until cesarean delivery | what was the indication for surgery |
| Maternal morbidity | from initiation until delivery | advanced tears (3rd and 4th degree) post partum hemorrhage uterine rupture, amnionitis |
| Patient satisfaction - by questioner | within 5 days from delivery | question addressing pain (bearable or unbearable, was the treatment comfortable for the women and would she do it again if necessary |
| time to delivery | from induction to delivery and from ruptured membranes to delivery | Mean time to delivery |
| Neonatal morbidity: | within 5 days from delivery | neonatal care unit admission, meconium with\\without fetal heart rate changes, Apgar 5' \<7 , |
| use of oxytocin | within 24 hours | if it was in use at all (yes\\no) and if yes- so for how long (time from initiation until delivery) |
| use of emergent tocolysis | from induction until delivery | IV atosiban for tachysystole |
| how many doses of misoprostol | from induction until delivery | counting the number of administered doses |
| tachysystole | from initiation until delivery | more than 5 contractions in 10 min with or without fetal heart rate changes |
| Use of other ripening methods after failure of the allocated method | 24 hours after initiation of the treatment | if the allocated measure was defined as failed after 24 hours, other methods will be used to ripen the cervix. |
Countries
Israel
Outcome results
None listed