Induction of labor at 41 completed gestational weeks versus expectant management and induction at 42 completed gestational weeks

Conditions

Prolonged pregnancy, post-term birth Pregnancy and Childbirth Prolonged pregnancy, post-term infant, not heavy for gestational age

Helena Nilvér, Anna Wessberg, Anna Dencker, Henrik Hagberg, Ulla‐Britt Wennerholm et al. (13 authors)

BMJ Open2021-04-0124 citations

10.1136/bmjopen-2020-042340

Induction of labour at 41 weeks versus expectant management and induction of labour at 42 weeks (SWEdish Post-term Induction Study, SWEPIS): multicentre, open label, randomised, superiority trial

Ulla‐Britt Wennerholm, Sissel Saltvedt, Anna Wessberg, Mårten Alkmark, Christina Bergh et al. (16 authors)

BMJ2019-11-20169 citations

10.1136/bmj.l6131

Study protocol of SWEPIS a Swedish multicentre register based randomised controlled trial to compare induction of labour at 41 completed gestational weeks versus expectant management and induction at 42 completed gestational weeks.

Elden H, Hagberg H, Wessberg A, Sengpiel V, Herbst A, Bullarbo M, Bergh C, Bolin K, Malbasic S, Saltvedt S, Stephansson O, Wikström AK, Ladfors L, Wennerholm UB.

2016-03-0718 citations

10.1186/s12884-016-0836-9

Interventions

Current interventions as of 14/04/2020: Intervention group: Women are randomised at 40+6 to 41+1 weeks and induction is planned to take place at 41+0 to 41+2 weeks. Con

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Healthy women =18 years old with a normal live singleton pregnancy in cephalic presentation at 41+0 GW, who is able to understand oral and written information

Exclusion criteria

Exclusion criteria: 1. Women with previous caesarean section or other uterine surgery 2. Pregestational and insulin-dependent gestational diabetes 3. Hypertensive disorders in pregnancy including preeclampsia 4. Multiple pregnancy 5. Foetus in breech or transverse position 6. Oligohydramniosis (amniotic fluid index <50 mm or deepest vertical pocket <20 mm) 7. Small for gestational age (<-22% according to a Swedish reference) 8. Antenatally detected foetal malformations and contraindications to vaginal delivery such as placenta previa

Design outcomes

Primary

Measure	Time frame
Primary outcome will be a composite of stillbirth, neonatal mortality and neonatal morbidity. Stillbirth is defined as intrauterine foetal death of a foetus that was alive at randomisation. Neonatal mortality is defined as live births with death day 0-27. Neonatal morbidity is defined as at least one of the following variables: Apgar score 12 mmol/l in umbilical artery or pH <7.00 in umbilical artery, HIE I-III, intracranial haemorrhage, neonatal convulsions, meconium aspiration syndrome (MAS), mechanical ventilation, obstetric brachial plexus injury.	—

Measure

Time frame

Primary outcome will be a composite of stillbirth, neonatal mortality and neonatal morbidity. Stillbirth is defined as intrauterine foetal death of a foetus that was alive at randomisation. Neonatal mortality is defined as live births with death day 0-27. Neonatal morbidity is defined as at least one of the following variables: Apgar score 12 mmol/l in umbilical artery or pH <7.00 in umbilical artery, HIE I-III, intracranial haemorrhage, neonatal convulsions, meconium aspiration syndrome (MAS), mechanical ventilation, obstetric brachial plexus injury.

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Secondary

Measure	Time frame
Current secondary outcome measures as of 14/04/2020: 1. Secondary neonatal outcomes 1.1. Perinatal mortality, stillbirths and neonatal mortality assessed from patient notes on live births with death at 0 to 27 days 1.2. Stillbirths assessed from patient notes at 0 days 1.3. Neonatal mortality assessed from patient notes on live births with death at 0 to 27 days 1.4. Neonatal morbidity (at least one of the following variables: Apgar score 12 mmol/l in umbilical artery or pH 12 mmol/l in umbilical artery or pH 1000 ml) 4.10. Duration of labour (minutes) 4.11. Wound infection 4.12. Urinary tract infection 4.13. Endometritis, sepsis 4.14. Breastfeeding at discharge and 4 weeks after childbirth 4.15. Women’s attitudes and experiences at randomisation (Sub study) The following data on women’s attitudes, experiences and health-related quality of life will be collected by questionnaires (web based or postal): at randomisation in subpopulations in Gothenburg, Falun and Örebro 4.15.1 Personality (Big Five) 4.15.2 Health related quality of life (Euro-Qol –VAS & Euro-Qol-5D) 4.15.3 Depression/anxiety (HADS), 4.15.4 Self-efficacy (The General Self-Efficacy Scale [GES]) 4.16. Women’s attitudes and experiences 3 months after randomisation. The following data on women’s attitudes, experiences and health-related quality of life will be collected by questionnaires (web-based or postal) 3 months after randomisation in subpopulations in Gothenburg, Falun and Örebro 4.16.1 Health-related quality of life (Euro-Qol –VAS & Euro-Qol-5D) 4.16.2 Depression/anxiety (HADS) 4.16.3 Self-efficacy (The General Self-Efficacy Scale [GES])	—

Measure

Time frame

Current secondary outcome measures as of 14/04/2020: 1. Secondary neonatal outcomes 1.1. Perinatal mortality, stillbirths and neonatal mortality assessed from patient notes on live births with death at 0 to 27 days 1.2. Stillbirths assessed from patient notes at 0 days 1.3. Neonatal mortality assessed from patient notes on live births with death at 0 to 27 days 1.4. Neonatal morbidity (at least one of the following variables: Apgar score 12 mmol/l in umbilical artery or pH 12 mmol/l in umbilical artery or pH 1000 ml) 4.10. Duration of labour (minutes) 4.11. Wound infection 4.12. Urinary tract infection 4.13. Endometritis, sepsis 4.14. Breastfeeding at discharge and 4 weeks after childbirth 4.15. Women’s attitudes and experiences at randomisation (Sub study) The following data on women’s attitudes, experiences and health-related quality of life will be collected by questionnaires (web based or postal): at randomisation in subpopulations in Gothenburg, Falun and Örebro 4.15.1 Personality (Big Five) 4.15.2 Health related quality of life (Euro-Qol –VAS & Euro-Qol-5D) 4.15.3 Depression/anxiety (HADS), 4.15.4 Self-efficacy (The General Self-Efficacy Scale [GES]) 4.16. Women’s attitudes and experiences 3 months after randomisation. The following data on women’s attitudes, experiences and health-related quality of life will be collected by questionnaires (web-based or postal) 3 months after randomisation in subpopulations in Gothenburg, Falun and Örebro 4.16.1 Health-related quality of life (Euro-Qol –VAS & Euro-Qol-5D) 4.16.2 Depression/anxiety (HADS) 4.16.3 Self-efficacy (The General Self-Efficacy Scale [GES])

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Countries

Sweden

Outcome results

None listed