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Completed

NCT Number: NCT04271722

Clinical Evaluation of Cervical Ripening in the Outpatient Setting

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

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar Lisboa Norte

Lisbon, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cervical ripening

Other

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 outcomes

  1. Number of Participants with Bishop score ≥6 or spontaneous labour

    Time frame: 24 hours

    Proportion of patients (%) with Bishop score ≥6 or spontaneous labour 24 hours after intervention

Secondary outcomes

  1. Mean of gain in Bishop score

    Time frame: 24 hours

    Mean of gain in Bishop score from intervention to hospital admission

  2. Time frame between intervention and active phase of labour

    Time frame: 1-2 days

    Time frame between intervention and active phase of labour (min)

  3. Time of Vaginal Delivery

    Time frame: 2-4days

    Delivery time frame in mins from intervention

  4. Number of Participants with vaginal delivery within 24hrs

    Time frame: 1-2days

    Rate of vaginal deliveries within 24 hours since admission to hospital (%)

  5. Vaginal delivery within 48hrs

    Time frame: 1-2days

    Rate of vaginal deliveries within 48 hours since admission to hospital (%)

  6. Pharmacological agents for labor induction (Prostaglandins, Oxytocin)

    Time frame: 1-2days

    Rate of women that required pharmacological cervical ripening agents (%) requirement (%)

  7. Operative deliveries

    Time frame: 1-4days

    Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance.

  8. Cesarean deliveries

    Time frame: 1-4days

    Proportion of patients that delivered by cesarean (%).

  9. Analgesia requirement

    Time frame: 24 hours

    Rate of women who require any analgesia during cervical ripening process (%)

  10. Vaginal bleeding

    Time frame: 24 hours

    Rate of women who had vaginal bleeding during cervical ripening process (%)

  11. Reduced fetal movements

    Time frame: 24 hours

    Rate of women who had reduced fetal movements during cervical ripening process (%)

  12. Non reassuring fetal status

    Time frame: 24 hours

    Rate of women who had non reassuring fetal status(CTG) during cervical ripening process (%)

  13. Patient Satisfaction: questionnaire

    Time frame: 1-4days

    Patient satisfaction associated with intervention used for cervical ripening from patient questionnaire

Other outcomes

  1. Neonatal Intensive Care Unit admission

    Time frame: 1-30 days

    Rate of newborns admitted in Neonatal Intensive Care Unit (%)

  2. Postpartum haemorrhage

    Time frame: 1-7 days

    Rate of women with postpartum haemorrhage (%)

  3. 5 minute apgar score <7

    Time frame: 1-4 days

    Rate of newborns with 5 minute apgar score <7 (%)

  4. 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) (%)

  5. Neonatal mortality

    Time frame: 1-7days

    Rate of neonatal mortality (%)

Sponsors and collaborators

Lead sponsor

Centro Hospitalar Lisboa Norte

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2020
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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