Labor; Forced or Induced, Affecting Fetus or Newborn, Labor Onset and Length Abnormalities
Conditions
Keywords
cervical ripening, mifepristone, balloon catheter
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.
Interventions
OTHERCervical 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.
Sponsors
Centro Hospitalar Lisboa Norte
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Bishop score ≥6 or spontaneous labour | 24 hours | Proportion of patients (%) with Bishop score ≥6 or spontaneous labour 24 hours after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean of gain in Bishop score | 24 hours | Mean of gain in Bishop score from intervention to hospital admission |
| Vaginal delivery within 48hrs | 1-2days | Rate of vaginal deliveries within 48 hours since admission to hospital (%) |
| Pharmacological agents for labor induction (Prostaglandins, Oxytocin) | 1-2days | Rate of women that required pharmacological cervical ripening agents (%) requirement (%) |
| Reduced fetal movements | 24 hours | Rate of women who had reduced fetal movements during cervical ripening process (%) |
| Non reassuring fetal status | 24 hours | Rate of women who had non reassuring fetal status(CTG) during cervical ripening process (%) |
| Patient Satisfaction: questionnaire | 1-4days | Patient satisfaction associated with intervention used for cervical ripening from patient questionnaire |
| Operative deliveries | 1-4days | Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance. |
| Cesarean deliveries | 1-4days | Proportion of patients that delivered by cesarean (%). |
| Analgesia requirement | 24 hours | Rate of women who require any analgesia during cervical ripening process (%) |
| Vaginal bleeding | 24 hours | Rate of women who had vaginal bleeding during cervical ripening process (%) |
| Time frame between intervention and active phase of labour | 1-2 days | Time frame between intervention and active phase of labour (min) |
| Time of Vaginal Delivery | 2-4days | Delivery time frame in mins from intervention |
| Number of Participants with vaginal delivery within 24hrs | 1-2days | Rate of vaginal deliveries within 24 hours since admission to hospital (%) |
Other
| Measure | Time frame | Description |
|---|---|---|
| 5 minute apgar score <7 | 1-4 days | Rate of newborns with 5 minute apgar score \<7 (%) |
| Metabolic acidosis(pH< 7.00 e BD > 12 mmol/l) | 1-4 days | Rate of metabolic acidosis (pH\< 7.00 e BD \> 12 mmol/l) (%) |
| Neonatal mortality | 1-7days | Rate of neonatal mortality (%) |
| Neonatal Intensive Care Unit admission | 1-30 days | Rate of newborns admitted in Neonatal Intensive Care Unit (%) |
| Postpartum haemorrhage | 1-7 days | Rate of women with postpartum haemorrhage (%) |
Countries
Portugal
Outcome results
None listed