OPTION – OutPatienT InductiON: Labour induction in an outpatient setting - a multicentre randomized controlled trial
- Conditions
- Induction of labourTherapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Registration Number
- CTIS2023-507164-39-00
- Lead Sponsor
- Vaestra Goetalandsregionen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 8891
Based on medical history: women 18-45 years old, Based on medical history: 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 medical history: able to communicate with the hospital, Based on medical history: uncomplicated live singleton pregnancy, Based on medical history: pregnancy week =37+0 to 41+6 according to crown rump length (CRL) or biparietal diameter (BPD<55 mm) at first or second trimester ultrasound, Based on medical history: Stable cephalic presentation, Based on clinical examination before start of induction including Leopold´s manoeuvres, digital cervical exam, abdominal ultrasound, blood pressure and CTG scan, if indicated temperature: Stable cephalic presentation., Based on clinical examination before start of induction including Leopold´s manoeuvres, digital cervical exam, abdominal ultrasound, blood pressure and CTG scan, if indicated temperature: Bishop score <6, Based on clinical examination before start of induction including Leopold´s manoeuvres, digital cervical exam, abdominal ultrasound, blood pressure and CTG scan, if indicated temperature: CTG classified as normal according to the antepartal Swedish Society of Obstetrics and Gynaecology (Svensk Förening för Obstetrik och Gynekologi, SFOG) criteria (www.ctgutbildning.se), Based on observation the first 45 min after start of induction: in case of induction with catheter method: CTG classified as normal according to the antepartal Swedish Society of Obstetrics and Gynaecology (Svensk Förening för Obstetrik och Gynekologi, SFOG) criteria (www.ctgutbildning.se)
Based on medical history: previous uterine surgery with uterine scar, e.g. caesarean section or myomectomy, Based on medical history: pregestational (diagnosis before pregnancy or before gestational week 25) or insulin treated gestational diabetes, 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, Based on observation the first 45 min after start of induction: start of contractions, Based on medical history: dietary or metformin treated gestational diabetes with small or large for gestational age foetus, Based on medical history: preeclampsia or instable hypertensive disease, Based on medical history: Intrahepatic cholestasis with serum bile acids =40 µmol/L, Based on medical history: intrauterine foetal death (IUFD) in previous pregnancy, Based on medical history: known foetal malformations or other foetal condition affecting the delivery or immediate care of the new-born, Based on medical history: congenital uterine malformation which may affect safety, Based on medical history: other condition requiring inpatient care, e.g. delivery within 60 min from arriving at the hospital in previous pregnancy, Based on medical history: Known small for gestational age (SGA) defined as <2 standard deviations according to Marsal et al or intrauterine growth restriction (IUGR), Based on clinical examination before start of induction including Leopold´s manoeuvres, digital cervical exam, abdominal ultrasound, blood pressure and CTG scan, if indicated temperature: •Small for gestational age (SGA) defined as <2 and in case of diabetes either large for gestational age (LGA) defined as >2 standard deviation according to Marsal et al or suspected growth acceleration., Based on medical history: known allergy to any of the components of the balloon catheter or Angusta® (for the respective method only), Based on clinical examination before start of induction including Leopold´s manoeuvres, digital cervical exam, abdominal ultrasound, blood pressure and CTG scan, if indicated temperature: If the criteria outlined below are not met in their respective situation, the patient shall be excluded from the study: 1) In case of late term =41+0 to 41+6 weeks abdominal ultrasound will be performed and mean abdominal diameter (MAD) must be =110 mm. In case MAD <110 mm, the foetal weight will be estimated to exclude SGA foetus defined as <2 standard deviations according to Marsal et al the patient should be excluded. 2) In case of dietary or metformin treated gestational diabetes foetal weight to be or have been estimated by abdominal ultrasound within the last three weeks before induction and the result needs to be within normal range. 3) In case of stable hypertension foetal weight needs to be estimated by abdominal ultrasound within the last two weeks before induction and showing no SGA/IUGR foetus. 4) In case of indication for induction being prolonged latent phase, maternal age, mild intrahepatic cholestasis, pelvic girdle pain, PROM or psychosocial, a normal fundal height measurement according to the Swedish reference curves must be normal. In case of not-normal fundal height measurement: foetal weight estimation must be performed and showing no SGA/IUGR. 5) For all other indications foetal weight is estimated by abdominal ultrasound at the discretion of the investigator., Based on clinical ex
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method