NCT04271722

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

3 years

First QC Date

February 13, 2020

Last Update Submit

May 30, 2024

Conditions

Labor; Forced or Induced, Affecting Fetus or NewbornLabor Onset and Length Abnormalities

Keywords

cervical ripeningmifepristoneballoon catheter

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (13)

  • Mean of gain in Bishop score

    24 hours

  • Time frame between intervention and active phase of labour

    1-2 days

  • Time of Vaginal Delivery

    2-4days

  • Number of Participants with vaginal delivery within 24hrs

    1-2days

  • Vaginal delivery within 48hrs

    1-2days

  • +8 more secondary outcomes

Other Outcomes (5)

  • Neonatal Intensive Care Unit admission

    1-30 days

  • Postpartum haemorrhage

    1-7 days

  • 5 minute apgar score <7

    1-4 days

  • +2 more other outcomes

Study Arms (2)

Mifepristone

EXPERIMENTAL

Mifepristone 200mg 24hours before the induction day

Other: Cervical ripening

Balloon catheter

ACTIVE COMPARATOR

Balloon catheter with 40ml placed 24hours before the induction day

Other: Cervical ripening

Interventions

Cervical ripeningOTHER

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

Balloon catheterMifepristone

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar Lisboa Norte

Lisbon, Portugal

Location

Related Publications (10)

  • 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.

    PMID: 29211328BACKGROUND

  • 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.

    PMID: 14698071BACKGROUND

  • 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.

    PMID: 19258402BACKGROUND

  • 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.

    PMID: 22759411BACKGROUND

  • 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.

    PMID: 2407284BACKGROUND

  • 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.

    PMID: 2918074BACKGROUND

  • 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.

    PMID: 9794673BACKGROUND

  • 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.

    PMID: 26243986BACKGROUND

  • 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.

    PMID: 28898687BACKGROUND

  • 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.

    PMID: 28901007BACKGROUND

MeSH Terms

Interventions

Cervical Ripening

Intervention Hierarchy (Ancestors)

Labor, ObstetricPregnancyReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Phd Student

Study Record Dates

First Submitted

February 13, 2020

First Posted

February 17, 2020

Study Start

January 15, 2020

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

May 31, 2024

Record last verified: 2024-05

Locations

PT(1)