Obstetrics: induction of labor Pregnancy and Childbirth
Conditions
Interventions
Eligible patients fulfilling study criteria on weekdays (Monday to Friday inclusive) were approached for study participation. Study participation was induction with Dilapan-S versus routine induction
Sponsors
National Maternity Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women in their first pregnancy (nulliparous women) 2. Adequate English to understand the purpose of the study 3. Scheduled for induction of labor for post-dates (=41 weeks gestation) 4. Unfavorable cervix defined as Bishops Score =6 5. Not suitable for artificial rupture of membranes (ARM)
Exclusion criteria
Exclusion criteria: 1. Any pre-existing medical condition or medical condition of pregnancy 2. Pathological CTG prior to induction 3. Oligohydramnios on post-dates scan 4. 2 or more LLETZ treatments 5. Maternal age 40 years old 6. Body mass index =30kg/m2 7. Women with a closed cervix, insertion was not possible and so were unable to receive Dilapan-S
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Compliance with study protocol, quantified as the proportion of women who agreed to study participation and who completed the trial protocol of insertion of Dilapan-S. This occurred at time of insertion of the product 2. Safety: Maternal infection defined as maternal temperature greater than 38°C, endometritis, chorioamnionitis or antibiotic usage following study allocation until delivery of baby 3. Safety: Maternal hyperstimulation defined as > 7 contractions in 15 minutes at any time following study allocation until delivery of baby 4. Safety: Neonatal infection defined as fever, suspected or proven sepsis, or need for antibiotic use in the first 72 hours of life 5. Safety: Neonatal Apgar scores at 1 and 5 minutes of life | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Bishop’s score pre and post-induction (within 24 hours of insertion of induction agent) 2. Complications associated with induction agent (within 24 hours of insertion of induction agent): 2.1. Cervical injury 2.2. Bleeding during insertion or removal 2.3. Spontaneous expulsion 2.4. Retraction into cavity 2.5. Dilator entrapment 2.6. Dilator fragmentation 2.7. Rupture of membranes 2.8. Other 3. Median duration from induction to delivery in minutes 4. Median duration of induction agent in situ in minutes 5. Delivery within 24 hours of receiving induction of labor method 6. Cesarean delivery rate 7. Instrumental delivery rate 8. Additional use of prostaglandin (1 or 2 doses) after reassessment following removal of initial product (Dilapan-S or Dinoprostone) 9. Additional use of oxytocin for labour induction or augmentation 10. Epidural use in labor 11. 3rd and 4th degree tears 12. Manual removal of placenta 13. Postpartum hemorrhage > 1L and post-partum blood transfusion (within 72 hours of delivery) 14. Meconium at delivery 15. Neonatal intensive care unit (NICU) admission (within 72 hours of delivery) | — |
Countries
Ireland
Outcome results
None listed