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Clinical Evaluation of Cervical Ripening in the Outpatient Setting

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Cervical ripening
Sponsored by
Centro Hospitalar Lisboa Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor; Forced or Induced, Affecting Fetus or Newborn focused on measuring cervical ripening, mifepristone, balloon catheter

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Centro Hospitalar Lisboa NorteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mifepristone

Balloon catheter

Arm Description

Mifepristone 200mg 24hours before the induction day

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

Outcomes

Primary Outcome Measures

Number of Participants with Bishop score ≥6
Proportion of patients (%) with Bishop score ≥6 24 hours after intervention

Secondary Outcome Measures

Mean of gain in Bishop score
Mean of gain in Bishop score from intervention to hospital admission
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
Time frame between intervention and active phase of labour
Time frame between intervention and active phase of labour (min)
Time of Vaginal Delivery
Delivery time frame in mins from intervention
Number of Participants with vaginal delivery within 24hrs
Rate of vaginal deliveries within 24 hours since admission to hospital (%)
Vaginal delivery within 48hrs
Rate of vaginal deliveries within 48 hours since admission to hospital (%)
Pharmacological agents for labor induction (Prostaglandins, Oxytocin)
Rate of women that required pharmacological cervical ripening agents (%) requirement (%)
Operative deliveries
Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance.
Cesarean deliveries
Proportion of patients that delivered by cesarean (%).
Analgesia requirement
Rate of women who require any analgesia during cervical ripening process (%)
Vaginal bleeding
Rate of women who had vaginal bleeding during cervical ripening process (%)
Reduced fetal movements
Rate of women who had reduced fetal movements during cervical ripening process (%)
Non reassuring fetal status
Rate of women who had non reassuring fetal status(CTG) during cervical ripening process (%)
Patient Satisfaction: questionnaire
Patient satisfaction associated with intervention used for cervical ripening from patient questionnaire

Full Information

First Posted
February 13, 2020
Last Updated
August 24, 2021
Sponsor
Centro Hospitalar Lisboa Norte
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1. Study Identification

Unique Protocol Identification Number
NCT04271722
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
January 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Hospitalar Lisboa Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor; Forced or Induced, Affecting Fetus or Newborn, Labor Onset and Length Abnormalities
Keywords
cervical ripening, mifepristone, balloon catheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mifepristone
Arm Type
Experimental
Arm Description
Mifepristone 200mg 24hours before the induction day
Arm Title
Balloon catheter
Arm Type
Active Comparator
Arm Description
Balloon catheter with 40ml placed 24hours before the induction day
Intervention Type
Other
Intervention Name(s)
Cervical ripening
Intervention Description
Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
Primary Outcome Measure Information:
Title
Number of Participants with Bishop score ≥6
Description
Proportion of patients (%) with Bishop score ≥6 24 hours after intervention
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Mean of gain in Bishop score
Description
Mean of gain in Bishop score from intervention to hospital admission
Time Frame
24 hours
Title
Number of Participants in active phase of labour (≥4 cm dilatation + ≥ 80% effacement and regular contractions) without need of further medication
Description
Proportion of patients (%) in active phase of labour (≥4 cm dilatation + ≥ 80% effacement and regular contractions) without need of further medication
Time Frame
1-2 days
Title
Time frame between intervention and active phase of labour
Description
Time frame between intervention and active phase of labour (min)
Time Frame
1-2 days
Title
Time of Vaginal Delivery
Description
Delivery time frame in mins from intervention
Time Frame
2-4days
Title
Number of Participants with vaginal delivery within 24hrs
Description
Rate of vaginal deliveries within 24 hours since admission to hospital (%)
Time Frame
1-2days
Title
Vaginal delivery within 48hrs
Description
Rate of vaginal deliveries within 48 hours since admission to hospital (%)
Time Frame
1-2days
Title
Pharmacological agents for labor induction (Prostaglandins, Oxytocin)
Description
Rate of women that required pharmacological cervical ripening agents (%) requirement (%)
Time Frame
1-2days
Title
Operative deliveries
Description
Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance.
Time Frame
1-4days
Title
Cesarean deliveries
Description
Proportion of patients that delivered by cesarean (%).
Time Frame
1-4days
Title
Analgesia requirement
Description
Rate of women who require any analgesia during cervical ripening process (%)
Time Frame
24 hours
Title
Vaginal bleeding
Description
Rate of women who had vaginal bleeding during cervical ripening process (%)
Time Frame
24 hours
Title
Reduced fetal movements
Description
Rate of women who had reduced fetal movements during cervical ripening process (%)
Time Frame
24 hours
Title
Non reassuring fetal status
Description
Rate of women who had non reassuring fetal status(CTG) during cervical ripening process (%)
Time Frame
24 hours
Title
Patient Satisfaction: questionnaire
Description
Patient satisfaction associated with intervention used for cervical ripening from patient questionnaire
Time Frame
1-4days
Other Pre-specified Outcome Measures:
Title
Neonatal Intensive Care Unit admission
Description
Rate of newborns admitted in Neonatal Intensive Care Unit (%)
Time Frame
1-30 days
Title
Postpartum haemorrhage
Description
Rate of women with postpartum haemorrhage (%)
Time Frame
1-7 days
Title
5 minute apgar score <7
Description
Rate of newborns with 5 minute apgar score <7 (%)
Time Frame
1-4 days
Title
Metabolic acidosis(pH< 7.00 e BD > 12 mmol/l)
Description
Rate of metabolic acidosis (pH< 7.00 e BD > 12 mmol/l) (%)
Time Frame
1-4 days
Title
Neonatal mortality
Description
Rate of neonatal mortality (%)
Time Frame
1-7days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Afonso, MD
Phone
00351918210100
Email
mariafonso@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Andreia Fonseca, MD
Phone
00351963189460
Email
andreiafonseca@gmail.com
Facility Information:
Facility Name
Centro Hospitalar Lisboa Norte
City
Lisboa
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Afonso, MD
Phone
0035191210100
Email
mariafonso@yahoo.com
First Name & Middle Initial & Last Name & Degree
Maria Afonso, MD
First Name & Middle Initial & Last Name & Degree
Andreia Fonseca, MD
First Name & Middle Initial & Last Name & Degree
Diogo Ayres de Campos, PhD,MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
29211328
Citation
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Results Reference
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PubMed Identifier
14698071
Citation
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.
Results Reference
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PubMed Identifier
19258402
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
2407284
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. doi: 10.1111/j.1471-0528.1990.tb01714.x.
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Clinical Evaluation of Cervical Ripening in the Outpatient Setting

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