Not provided
Not provided
Not provided
Not provided
RECRUTIMENT DIFICULTIES
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MISOPROSTOL | Active Comparator |
|
|
| DOUBLE BALLOON | Active Comparator |
|
|
| MISOPROSTOL+DOUBLE BALLOON | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol Oral Tablet | Drug | 50 mcg oral consumption |
|
| Measure | Description | Time Frame |
|---|---|---|
| the rate of cesarean delivery | percentage of cesarean delivery from all deliveries | from induction until delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Bishop score difference between groups | cervical change evaluation | after 6 hours and after 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| time to delivery | Mean time to delivery | from induction to delivery and from ruptured membranes to delivery |
| Use of other ripening methods after "failure" of the allocated method | if the allocated measure was defined as "failed" after 24 hours, other methods will be used to ripen the cervix. |
Inclusion Criteria:
Exclusion Criteria:
pregnant population
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bnai Zion Mc | Haifa | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19623003 | Background | ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available. | |
| 24565430 | Background | American College of Obstetricians and Gynecologists (College); Society for Maternal-Fetal Medicine; Caughey AB, Cahill AG, Guise JM, Rouse DJ. Safe prevention of the primary cesarean delivery. Am J Obstet Gynecol. 2014 Mar;210(3):179-93. doi: 10.1016/j.ajog.2014.01.026. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| double balloon device for cervical ripening | Device | insertion for 6 hours and followed by the above mentioned protocol |
|
| 24 hours after initiation of the treatment |
| Rate of achieving active phase of labor (≥ 5 cm cervical dilatation) | how many women had more than 5 cm cervical dilatation | within 24 hours of initiation |
| Cesarean delivery indication (non progressive labor or non reassuring fetal heart rate NRFHR) | what was the indication for surgery | from initiation until cesarean delivery |
| Maternal morbidity | advanced tears (3rd and 4th degree) post partum hemorrhage uterine rupture, amnionitis | from initiation until delivery |
| Patient satisfaction - by questioner | question addressing pain (bearable or unbearable, was the treatment comfortable for the women and would she do it again if necessary | within 5 days from delivery |
| tachysystole | more than 5 contractions in 10 min with or without fetal heart rate changes | from initiation until delivery |
| Neonatal morbidity: | neonatal care unit admission, meconium with\without fetal heart rate changes, Apgar 5' <7 , | within 5 days from delivery |
| use of oxytocin | if it was in use at all (yes\no) and if yes- so for how long (time from initiation until delivery) | within 24 hours |
| use of emergent tocolysis | IV atosiban for tachysystole | from induction until delivery |
| how many doses of misoprostol | counting the number of administered doses | from induction until delivery |
| 30089070 | Background | Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566. |
| 26341068 | Background | Schoen C, Navathe R. Failed induction of labor. Semin Perinatol. 2015 Oct;39(6):483-7. doi: 10.1053/j.semperi.2015.07.013. Epub 2015 Sep 2. |
| 29138035 | Background | Grobman WA, Bailit J, Lai Y, Reddy UM, Wapner RJ, Varner MW, Thorp JM Jr, Leveno KJ, Caritis SN, Prasad M, Tita ATN, Saade G, Sorokin Y, Rouse DJ, Blackwell SC, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Defining failed induction of labor. Am J Obstet Gynecol. 2018 Jan;218(1):122.e1-122.e8. doi: 10.1016/j.ajog.2017.11.556. Epub 2017 Nov 11. |
| 29078939 | Background | Penfield CA, Wing DA. Labor Induction Techniques: Which Is the Best? Obstet Gynecol Clin North Am. 2017 Dec;44(4):567-582. doi: 10.1016/j.ogc.2017.08.011. |
| 28342186 | Background | Weeks AD, Navaratnam K, Alfirevic Z. Simplifying oral misoprostol protocols for the induction of labour. BJOG. 2017 Oct;124(11):1642-1645. doi: 10.1111/1471-0528.14657. Epub 2017 May 15. No abstract available. |
| 29203813 | Background | Salim R, Schwartz N, Zafran N, Zuarez-Easton S, Garmi G, Romano S. Comparison of single- and double-balloon catheters for labor induction: a systematic review and meta-analysis of randomized controlled trials. J Perinatol. 2018 Mar;38(3):217-225. doi: 10.1038/s41372-017-0005-7. Epub 2017 Dec 4. |
| 28561987 | Background | Husain S, Husain S, Izhar R. Oral misoprostol alone versus oral misoprostol and Foley's catheter for induction of labor: A randomized controlled trial. J Obstet Gynaecol Res. 2017 Aug;43(8):1270-1277. doi: 10.1111/jog.13354. Epub 2017 May 31. |
|
| 27824758 | Background | Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778. |
| 22419277 | Background | Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2. |
| 36996264 | Derived | de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4. |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |