Clinical Evaluation of Cervical Ripening in the Outpatient Setting

Labor Onset and Length Abnormalities Clinical Trial

Official title:

Clinical Evaluation of Cervical Ripening in the Outpatient Setting Using Mifepristone Versus Balloon Catheter: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04271722
• Other study ID #: 2020OBST1
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: August 2021
• Source: Centro Hospitalar Lisboa Norte
• Contact: Maria Afonso, MD
• Phone: 00351918210100
• Email: mariafonso[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Labor Onset and Length Abnormalities
• Labor; Forced or Induced, Affecting Fetus or Newborn

Intervention

Other:
• Cervical ripening
Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Lisboa Norte	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar Lisboa Norte

Country where clinical trial is conducted

Portugal, 

References & Publications (10)

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. — View Citation

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. — View 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. — View 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. — View Citation

Heikinheimo O, Kekkonen R, Lähteenmäki P. The pharmacokinetics of mifepristone in humans reveal insights into differential mechanisms of antiprogestin action. Contraception. 2003 Dec;68(6):421-6. — View Citation

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. — View 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. — View Citation

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. — View 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:CD007701. doi: 10.1002/14651858.CD007701.pub3. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neonatal Intensive Care Unit admission	Rate of newborns admitted in Neonatal Intensive Care Unit (%)	1-30 days
Other	Postpartum haemorrhage	Rate of women with postpartum haemorrhage (%)	1-7 days
Other	5 minute apgar score <7	Rate of newborns with 5 minute apgar score <7 (%)	1-4 days
Other	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
Other	Neonatal mortality	Rate of neonatal mortality (%)	1-7days
Primary	Number of Participants with Bishop score =6	Proportion of patients (%) with Bishop score =6 24 hours after intervention	24 hours
Secondary	Mean of gain in Bishop score	Mean of gain in Bishop score from intervention to hospital admission	24 hours
Secondary	Number of Participants in active phase of labour (=4 cm dilatation + = 80% effacement and regular contractions) without need of further medication	Proportion of patients (%) in active phase of labour (=4 cm dilatation + = 80% effacement and regular contractions) without need of further medication	1-2 days
Secondary	Time frame between intervention and active phase of labour	Time frame between intervention and active phase of labour (min)	1-2 days
Secondary	Time of Vaginal Delivery	Delivery time frame in mins from intervention	2-4days
Secondary	Number of Participants with vaginal delivery within 24hrs	Rate of vaginal deliveries within 24 hours since admission to hospital (%)	1-2days
Secondary	Vaginal delivery within 48hrs	Rate of vaginal deliveries within 48 hours since admission to hospital (%)	1-2days
Secondary	Pharmacological agents for labor induction (Prostaglandins, Oxytocin)	Rate of women that required pharmacological cervical ripening agents (%) requirement (%)	1-2days
Secondary	Operative deliveries	Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance.	1-4days
Secondary	Cesarean deliveries	Proportion of patients that delivered by cesarean (%).	1-4days
Secondary	Analgesia requirement	Rate of women who require any analgesia during cervical ripening process (%)	24 hours
Secondary	Vaginal bleeding	Rate of women who had vaginal bleeding during cervical ripening process (%)	24 hours
Secondary	Reduced fetal movements	Rate of women who had reduced fetal movements during cervical ripening process (%)	24 hours
Secondary	Non reassuring fetal status	Rate of women who had non reassuring fetal status(CTG) during cervical ripening process (%)	24 hours
Secondary	Patient Satisfaction: questionnaire	Patient satisfaction associated with intervention used for cervical ripening from patient questionnaire	1-4days