Induction of labour
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Misoprostol
Other descriptive name: MISOPROSTOL
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-
Sponsors
Sahlgrenska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Based on medical history: • women 18-45 years old • able to communicate with the hospital • uncomplicated live singleton pregnancy • pregnancy week >=37+0 to 41+6 according to crown rump length (CRL) or biparietal diameter (BPD=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Based on medical history: • previous uterine surgery with uterine scar, e.g. caesarean section or myomectomy • pregestational or medically treated gestational diabetes (insulin or metformin) • dietary treated gestational diabetes with large for gestational age foetus • preeclampsia or instable hypertensive disease • multiple pregnancy • intrauterine foetal death (IUFD) in current or previous pregnancy • known foetal malformations or other foetal condition affecting the delivery or immediate care of the newborn • congenital uterine malformation which may affect safety • other condition requiring inpatient care, e.g. delivery within 60 min from arriving at the hospital in previous pregnancy • not able to reach the hospital in a reasonable time, at the discretion of the investigator with a maximum of 60 min as a benchmark Based on clinical examination before start of induction including Leopold's manoeuvres, digital cervical exam, abdominal ultrasound, temperature, blood pressure and cardiotocography (CTG) scan: • Small for gestational age (SGA/IUGR/FGA) Screened for as follows depending on the indication for induction: 1. late term >=41+0 to 41+6 weeks: abdominal ultrasound will be performed and mean abdominal diameter (MAD) needs to be >= 110 mm In case MAD 300 mm • maternal pyrexia >= 38 degrees Celsius • known low-lying placenta (less than 20 mm from internal os measured by vaginal ultrasound in week 36) • high head (>=4/5 palpable abdominally) Regarding premature rupture of membranes (PROM): • exclusion criteria for balloon method • exclusion criteria for prostaglandin method if: o PROM >30 hours o Known colonisation with group B streptococci or previous pregnancy complication linked to group B streptococcus Based on observation the first 45 min after start of induction: • any adverse events within the first 45 min after start of induction, e.g. heavy bleeding, pain, PROM in case PROM was not indication for induction of labour • start of contractions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To establish if induction in an outpatient setting is as safe for the child (composite outcome for mortality and severe morbidity) as induction in a hospital setting, including low-risk women only. 2. To investigate efficacy of outpatient induction by comparing proportions of women with vaginal delivery in the whole study population as well as in the group of women induced with either balloon or prostaglandin.;Secondary Objective: 1. To investigate if other pregnancy and delivery-related outcomes differ btwn women induced in an outpatient vs hospital setting including safety, e.g. mother admitted to ICU, post-partum bleeding >1000ml, proportion of women delivered vaginally within 24 or 48 hrs from induction start as well as for the children, e.g. variables part of the primary safety composite outcome will be studied individually in exploratory analyses 2. To increase the understanding of women with low-risk induction experiences of induction in an outpatient and a hospital setting by comparison of general self-efficacy (GSE), health-related quality of life (EQ-VAS, EQ-5D), pain catastrophizing (PCS), sense of coherence (SOC), anxiety and depression (HAD) before randomization and 3 mon post-delivery. Childbirth experiences (CEQ), induction experiences, EPDS and breastfeeding levels (BSES) will be compared btwn groups 3 mon post-delivery. Qualitative interviews with 20-25 women will be done 3-6 mon post-delivery;Primary end point(s): 1. Safety defined as a composite outcome of severe perinatal morbidity or mortality 2. Efficacy defined as proportion of women with vaginal delivery;Timepoint(s) of evaluation of this end point: 1. For the safety primary endpoint, neonatal mortality is defined between day 0-27 and thus the time point is day 27 after delivery. 2. For the efficacy primary endpoint, the time point is upon delivery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Pregnancy and delivery-related outcomes (including safety, e.g. mother admitted to the intensive care unit, post-partum bleeding >1000 ml, proportion of women delivered vaginally within 24 or 48 hours from start of induction as well as for the children, e.g. the different variables being part of the primary safety composite outcome will be studied individually in form of exploratory analyses). These secondary end points are descriptive and obtained via registry data. 2. Woman and partner's experience of self-efficacy, health-related quality of life, pain catastrophizing, anxiety and depression; women and partners' experience of childhood experiences and levels of breastfeeding; women and partners' experience as per qualitative interviews 3. Understanding of healthcare staff's experience of outpatient vs inpatient induction of low-risk pregnancies 4. Cost-effectiveness 5. Future pregnancy outcome;Timepoint(s) of evaluation of this end point: 1. Up to 42 days after delivery. These secondary end points are descriptive and obtained via registry data. 2. 3-6 months after delivery compared to at randomization (questionnaires will be send out three months after delivery, interviews will take place 3-6 months after delivery) 3. At the earliest 6 months after introduction of outpatient induction 4. Completion of follow-up 5. 10 years after completion of recruitment | — |
Countries
Sweden
Contacts
Public ContactOPTION study
Sahlgrenska University Hospital
Outcome results
None listed