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A randomized controlled trial of mifepristone 200mg vs balloon catheter for cervical ripening.
Artificial induction of labour is currently required in 25-30% of all pregnancies, in high-resource countries. While the pharmacological modifications to the collagen matrix of the cervix, that allow it to dilate (cervical ripening) occur spontaneously in many women, allowing labour to be induced with oxytocin, in others the process needs to be triggered artificially. Cervical ripening is traditionally accomplished with prostaglandins or mechanical agents, in processes that typically require 12-24 hours of hospital stay. More recently, a limited number of hospitals have shifted towards starting the process in house, but then allowing women to return home and be re-evaluated on the following day.
The main aims this study is to compare efficacy and patient satisfaction of mifepristone vs balloon catheter for cervical ripening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mifepristone | Experimental | Mifepristone 200mg 24hours before the induction day |
|
| Balloon catheter | Active Comparator | Balloon catheter with 40ml placed 24hours before the induction day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical ripening | Other | Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Bishop score ≥6 or spontaneous labour | Proportion of patients (%) with Bishop score ≥6 or spontaneous labour 24 hours after intervention | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mean of gain in Bishop score | Mean of gain in Bishop score from intervention to hospital admission | 24 hours |
| Time frame between intervention and active phase of labour | Time frame between intervention and active phase of labour (min) |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Intensive Care Unit admission | Rate of newborns admitted in Neonatal Intensive Care Unit (%) | 1-30 days |
| Postpartum haemorrhage | Rate of women with postpartum haemorrhage (%) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar Lisboa Norte | Lisbon | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29211328 | Background | Diederen M, Gommers J, Wilkinson C, Turnbull D, Mol B. Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review. BJOG. 2018 Aug;125(9):1086-1095. doi: 10.1111/1471-0528.15047. Epub 2018 Jan 10. | |
| 14698071 |
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| ID | Term |
|---|---|
| D020070 | Cervical Ripening |
| ID | Term |
|---|---|
| D007743 | Labor, Obstetric |
| D011247 | Pregnancy |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
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| 1-2 days |
| Time of Vaginal Delivery | Delivery time frame in mins from intervention | 2-4days |
| Number of Participants with vaginal delivery within 24hrs | Rate of vaginal deliveries within 24 hours since admission to hospital (%) | 1-2days |
| Vaginal delivery within 48hrs | Rate of vaginal deliveries within 48 hours since admission to hospital (%) | 1-2days |
| Pharmacological agents for labor induction (Prostaglandins, Oxytocin) | Rate of women that required pharmacological cervical ripening agents (%) requirement (%) | 1-2days |
| Operative deliveries | Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance. | 1-4days |
| Cesarean deliveries | Proportion of patients that delivered by cesarean (%). | 1-4days |
| Analgesia requirement | Rate of women who require any analgesia during cervical ripening process (%) | 24 hours |
| Vaginal bleeding | Rate of women who had vaginal bleeding during cervical ripening process (%) | 24 hours |
| Reduced fetal movements | Rate of women who had reduced fetal movements during cervical ripening process (%) | 24 hours |
| Non reassuring fetal status | Rate of women who had non reassuring fetal status(CTG) during cervical ripening process (%) | 24 hours |
| Patient Satisfaction: questionnaire | Patient satisfaction associated with intervention used for cervical ripening from patient questionnaire | 1-4days |
| 1-7 days |
| 5 minute apgar score <7 | Rate of newborns with 5 minute apgar score <7 (%) | 1-4 days |
| Metabolic acidosis(pH< 7.00 e BD > 12 mmol/l) | Rate of metabolic acidosis (pH< 7.00 e BD > 12 mmol/l) (%) | 1-4 days |
| Neonatal mortality | Rate of neonatal mortality (%) | 1-7days |
| Heikinheimo O, Kekkonen R, Lahteenmaki P. The pharmacokinetics of mifepristone in humans reveal insights into differential mechanisms of antiprogestin action. Contraception. 2003 Dec;68(6):421-6. doi: 10.1016/s0010-7824(03)00077-5. |
| 19258402 | Background | Smith R, Smith JI, Shen X, Engel PJ, Bowman ME, McGrath SA, Bisits AM, McElduff P, Giles WB, Smith DW. Patterns of plasma corticotropin-releasing hormone, progesterone, estradiol, and estriol change and the onset of human labor. J Clin Endocrinol Metab. 2009 Jun;94(6):2066-74. doi: 10.1210/jc.2008-2257. Epub 2009 Mar 3. |
| 22759411 | Background | Ceccaldi PF, Saada J, Nicolas M, Ducarme G, Blot P, Guibourdenche J, Luton D. Modulation of free corticotrophin-releasing hormone, adrenal and placental steroid hormone levels induced by mifepristone during pregnancy. Fetal Diagn Ther. 2012;32(4):267-70. doi: 10.1159/000338927. Epub 2012 Jul 4. |
| 2407284 | Background | Rodger MW, Baird DT. Pretreatment with mifepristone (RU 486) reduces interval between prostaglandin administration and expulsion in second trimester abortion. Br J Obstet Gynaecol. 1990 Jan;97(1):41-5. doi: 10.1111/j.1471-0528.1990.tb01714.x. |
| 2918074 | Background | Urquhart DR, Bahzad C, Templeton AA. Efficacy of the antiprogestin mifepristone (RU 486) prior to prostaglandin termination of pregnancy. Hum Reprod. 1989 Feb;4(2):202-3. doi: 10.1093/oxfordjournals.humrep.a136872. |
| 9794673 | Background | Elliott CL, Brennand JE, Calder AA. The effects of mifepristone on cervical ripening and labor induction in primigravidae. Obstet Gynecol. 1998 Nov;92(5):804-9. doi: 10.1016/s0029-7844(98)00284-1. |
| 26243986 | Background | Yelikar K, Deshpande S, Deshpande R, Lone D. Safety and Efficacy of Oral Mifepristone in Pre-induction Cervical Ripening and Induction of Labour in Prolonged Pregnancy. J Obstet Gynaecol India. 2015 Jul;65(4):221-5. doi: 10.1007/s13224-014-0584-6. Epub 2014 Jul 11. |
| 28898687 | Background | Baev OR, Rumyantseva VP, Tysyachnyu OV, Kozlova OA, Sukhikh GT. Outcomes of mifepristone usage for cervical ripening and induction of labour in full-term pregnancy. Randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2017 Oct;217:144-149. doi: 10.1016/j.ejogrb.2017.08.038. Epub 2017 Sep 1. |
| 28901007 | Background | Vogel JP, Osoti AO, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Pharmacological and mechanical interventions for labour induction in outpatient settings. Cochrane Database Syst Rev. 2017 Sep 13;9(9):CD007701. doi: 10.1002/14651858.CD007701.pub3. |
| D012101 |
| Reproductive and Urinary Physiological Phenomena |