Clinical trial NCT04271722: Clinical Evaluation of Cervical Ripening in the Outpatient Setting
Official title: Clinical Evaluation of Cervical Ripening in the Outpatient Setting Using Mifepristone Versus Balloon Catheter: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor; Forced or Induced, Affecting Fetus or Newborn
Labor Onset and Length Abnormalities
Keywords: cervical ripening
mifepristone
balloon catheter
Lead sponsor: Centro Hospitalar Lisboa Norte
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial of mifepristone 200mg vs balloon catheter for cervical ripening.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Pregnant woman scheduled for induction of labor.
* Age between 18 and 45 years.
* Understanding and capable to sign informed consent.
* Singleton pregnancy.
* Gestational age ≥ 37 0/7 weeks.
* Live fetus in cephalic presentation.
* Intact membranes
* Bishop score \< 6
* Estimated fetal weight \< 4500g
* Without contraindication to vaginal delivery
* No major fetal anomaly

Exclusion Criteria:

* Previous cesarean section or myomectomy
* Hypertension
* Diabetes
* Thyroid disease
* Maternal conditions with high risk of placental insufficiency

Primary outcomes:
measure: Number of Participants with Bishop score ≥6 or spontaneous labour
timeFrame: 24 hours
Secondary outcomes:
measure: Mean of gain in Bishop score
timeFrame: 24 hours
measure: Time frame between intervention and active phase of labour
timeFrame: 1-2 days
measure: Time of Vaginal Delivery
timeFrame: 2-4days
measure: Number of Participants with vaginal delivery within 24hrs
timeFrame: 1-2days
measure: Vaginal delivery within 48hrs
timeFrame: 1-2days
measure: Pharmacological agents for labor induction (Prostaglandins, Oxytocin)
timeFrame: 1-2days
measure: Operative deliveries
timeFrame: 1-4days
measure: Cesarean deliveries
timeFrame: 1-4days
measure: Analgesia requirement
timeFrame: 24 hours
measure: Vaginal bleeding
timeFrame: 24 hours
measure: Reduced fetal movements
timeFrame: 24 hours
measure: Non reassuring fetal status
timeFrame: 24 hours
measure: Patient Satisfaction: questionnaire
timeFrame: 1-4days
Other outcomes:
measure: Neonatal Intensive Care Unit admission
timeFrame: 1-30 days
measure: Postpartum haemorrhage
timeFrame: 1-7 days
measure: 5 minute apgar score <7
timeFrame: 1-4 days
measure: Metabolic acidosis(pH< 7.00 e BD > 12 mmol/l)
timeFrame: 1-4 days
measure: Neonatal mortality
timeFrame: 1-7days
Locations:
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte
Study officials:
References:
citation: 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.
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.