OPTION – OutPatienT InductiON: Labour induction in an outpatient setting - a multicentre randomized controlled trial

Conditions

Induction of labour

Brief summary

Safety defined as a composite outcome of severe perinatal morbidity or mortality, Efficacy defined as proportion of women with vaginal delivery

Detailed description

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., 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, Understanding of healthcare staff's experience of outpatient vs inpatient induction of low-risk pregnancies, Cost-effectiveness, Future pregnancy outcome

Verena Sengpiel, Heléne Sangskär, Ulla‐Britt Wennerholm, Helen Elden, Kristina Gemzell‐Danielsson et al. (14 authors)

BMJ Open2025-08-01

10.1136/bmjopen-2024-093972

Interventions

DRUGAngusta 25 mikrogram tabletter

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Secondary

Measure	Time frame
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., 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, Understanding of healthcare staff's experience of outpatient vs inpatient induction of low-risk pregnancies, Cost-effectiveness, Future pregnancy outcome	—

Measure

Time frame

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., 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, Understanding of healthcare staff's experience of outpatient vs inpatient induction of low-risk pregnancies, Cost-effectiveness, Future pregnancy outcome

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Primary

Measure	Time frame
Safety defined as a composite outcome of severe perinatal morbidity or mortality, Efficacy defined as proportion of women with vaginal delivery	—

Countries

Sweden

Outcome results

None listed