Clinical Evaluation of Cervical Ripening in the Outpatient Setting

August 24, 2021 updated by: Maria de Carvalho Afonso, Centro Hospitalar Lisboa Norte

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Portugal
      • Lisboa, Portugal
        • Recruiting
        • Centro Hospitalar Lisboa Norte
        • Contact:
        • Principal Investigator:
          • Maria Afonso, MD
        • Sub-Investigator:
          • Andreia Fonseca, MD
        • Sub-Investigator:
          • Diogo Ayres de Campos, PhD,MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mifepristone
Mifepristone 200mg 24hours before the induction day
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.
Active Comparator: Balloon catheter
Balloon catheter with 40ml placed 24hours before the induction day
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Bishop score ≥6
Time Frame: 24 hours
Proportion of patients (%) with Bishop score ≥6 24 hours after intervention
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean of gain in Bishop score
Time Frame: 24 hours
Mean of gain in Bishop score from intervention to hospital admission
24 hours
Number of Participants in active phase of labour (≥4 cm dilatation + ≥ 80% effacement and regular contractions) without need of further medication
Time Frame: 1-2 days
Proportion of patients (%) in active phase of labour (≥4 cm dilatation + ≥ 80% effacement and regular contractions) without need of further medication
1-2 days
Time frame between intervention and active phase of labour
Time Frame: 1-2 days
Time frame between intervention and active phase of labour (min)
1-2 days
Time of Vaginal Delivery
Time Frame: 2-4days
Delivery time frame in mins from intervention
2-4days
Number of Participants with vaginal delivery within 24hrs
Time Frame: 1-2days
Rate of vaginal deliveries within 24 hours since admission to hospital (%)
1-2days
Vaginal delivery within 48hrs
Time Frame: 1-2days
Rate of vaginal deliveries within 48 hours since admission to hospital (%)
1-2days
Pharmacological agents for labor induction (Prostaglandins, Oxytocin)
Time Frame: 1-2days
Rate of women that required pharmacological cervical ripening agents (%) requirement (%)
1-2days
Operative deliveries
Time Frame: 1-4days
Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance.
1-4days
Cesarean deliveries
Time Frame: 1-4days
Proportion of patients that delivered by cesarean (%).
1-4days
Analgesia requirement
Time Frame: 24 hours
Rate of women who require any analgesia during cervical ripening process (%)
24 hours
Vaginal bleeding
Time Frame: 24 hours
Rate of women who had vaginal bleeding during cervical ripening process (%)
24 hours
Reduced fetal movements
Time Frame: 24 hours
Rate of women who had reduced fetal movements during cervical ripening process (%)
24 hours
Non reassuring fetal status
Time Frame: 24 hours
Rate of women who had non reassuring fetal status(CTG) during cervical ripening process (%)
24 hours
Patient Satisfaction: questionnaire
Time Frame: 1-4days
Patient satisfaction associated with intervention used for cervical ripening from patient questionnaire
1-4days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Intensive Care Unit admission
Time Frame: 1-30 days
Rate of newborns admitted in Neonatal Intensive Care Unit (%)
1-30 days
Postpartum haemorrhage
Time Frame: 1-7 days
Rate of women with postpartum haemorrhage (%)
1-7 days
5 minute apgar score <7
Time Frame: 1-4 days
Rate of newborns with 5 minute apgar score <7 (%)
1-4 days
Metabolic acidosis(pH< 7.00 e BD > 12 mmol/l)
Time Frame: 1-4 days
Rate of metabolic acidosis (pH< 7.00 e BD > 12 mmol/l) (%)
1-4 days
Neonatal mortality
Time Frame: 1-7days
Rate of neonatal mortality (%)
1-7days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Hospitalar Lisboa Norte

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2020

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

January 30, 2022

Study Registration Dates

First Submitted

February 13, 2020

First Submitted That Met QC Criteria

February 14, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020OBST1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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