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

• Register: ISRCTN
• Last refreshed on: 19 April 2021
• Main ID: ISRCTN26113652
• Date of registration: 30/03/2015
• Prospective Registration: Yes
• Primary sponsor: Sahlgrenska University Hospital
• Public title: Induction of labor at 41 completed gestational weeks versus expectant management and induction at 42 completed gestational weeks
• Scientific title: 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
• Date of first enrolment: 20/05/2016
• Target sample size: 10038
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN26113652
• Study type: Interventional
• Study design: Current study design as of 14/04/2020: Multicentre open label randomised controlled superiority trial; Previous study design: Multicentre register-based randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Helen Elden

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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.
Control group: Women randomised to expectant management/late induction will be induced at 42+0 weeks (and no later than 42+1 weeks). After randomisation, the women are followed-up at the ordinary antenatal clinic according to clinical routine for 41+0-42+0 weeks.

Methods of labour induction (early at 41+0-41+2 weeks or late at 42+0-42+1 weeks) will be according to the clinics’ routine.

Qualitative study I:
Initially, we will recruit 10 women in gestational week 41+0 to 41+ 4 and 7 partners. If needed, more participants will be recruited. We will use open-ended interviews to collect the data. The interviews will take place in gestational week 41+0 to 41+ 4. The women will be asked to describe their experiences of prolonged pregnancy. The partners will be encouraged to describe experiences regarding everyday life with the partner with the prolonged pregnancy. The interviews will last about 60 minutes and will be tape-recorded. All interviews will be transcribed verbatim. The data will be analyzed using phenomenological analysis. The women and their partners will be re-interviewed within 4 weeks after delivery. The same questions will be asked. Thus, women will be asked to describe how they experienced their prolonged pregnancy. Consequently, the partners will be asked to describe experiences regarding everyday life with the partner with the prolonged pregnancy.

Qualitative study II:
The aim of the qualitative study II in the project is to gain a deeper understanding of women’s liv

Primary Outcome(s)

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 <7 at 5 minutes, metabolic acidosis defined as pH <7.05 and base excess >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.

Secondary Outcome(s)

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 <7 at 5 minutes, metabolic acidosis defined as pH <7.05 and base excess >12 mmol/l in umbilical artery or pH <7.00 in umbilical artery, HIE I-III, intracranial hemorrhage, neonatal convulsions, meconium aspiration syndrome (MAS), mechanical ventilation within the first 72 hours, and obstetric brachial plexus injury)
1.5. Neonatal health assessed by the Apgar score <7 at 5 minutes
1.6. Metabolic acidosis defined as pH <7.05 and base excess >12 mmol/l in umbilical artery or pH <7.00 in umbilical artery
1.7. Hypoxic-ischaemic encephalopathy assessed using HIE I-III
1.8. Intracranial hemorrhage
1.9. Neonatal convulsions
1.10. Meconium aspiration syndrome (MAS)
1.11. Mechanical ventilation within the first 72 hours
1.12. Obstetric brachial plexus injury
2. Other secondary neonatal outcomes
2.1. Admittance to neonatal intensive care unit
2.2. Birth weight (grams)
2.3. Macrosomia (=4500 g)
2.4. Therapeutic hypothermia
2.5. Neonatal jaundice requiring phototherapy or exchange transfusion
2.6. Pneumonia, Sepsis
2.7. Cerebral palsy
3. Exploratory neonatal outcomes
3.1. Neonatal hypoglycemia, defined as P-glucose concentration <2.6 mmol/L after three hours
3.2. Birth trauma (fracture of long bone, clavicle, or skull, other neurological injury, retinal hemorrhage, or facial nerve palsy)
3.3. Small for gestational age
3.4. Large for gestational age
4. Secondary maternal outcomes in the main study and the substudies
4.1. Chorioamnionitis
4.2. Use of oxytocin
4.3. Use of epidural anesthesia
4.4. Shoulder dystocia
4.5. Caesarean section
4.6. Assisted vaginal delivery (vacuum extraction or forceps)
4.8. Perineal lacerations III-IV
4.9. Postpartum hemorrhage (>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])
4.16.4 The Childbirth Experience Questionnaire (CEQ)
5. Exploratory maternal outcomes
5.1. Cervical tear
5.2. Uterine rupture
5.3. Hypertensive disorders of pregnancy (pre-eclampsia,
gestational hypertension, eclampsia)
5.4. Venous thromboembolism
5.5. Duration of stay in hospital
5.6. Admission to intensive care unit
5.7. Mortality within 42 days
5.8. For women from clinics outside Gothenburg, Falun and Örebro we will register data on satisfaction with delivery (VAS 1-10) from medical records
6. Women’s experiences of a prolonged pregnancy measured through open-ended interviews with women and their partners.
7. Cost-effectiveness analyses (sub study). Economic cost consequences (measured as the cost per birth) of early induction of labour at late term (at 41 GW) compared with expectant management and late induction (at 42+0 GW) in healthy women with a singleton foetus in cephalic presentation. Cost-effectiveness analyses will be performed based on the cost per life-year gained and cost per quality-adjusted life year (QALY) gained. Costs taken into consideration will be both costs for the woman and the child. For the women: visits to midwife/obstetrician and antenatal surveillance from randomisation to discharge from hospital after delivery, the delivery cost including length of stay at hospital (mother and infant), time and examinations, drugs used for induction of labor, other drugs, material use, treatments, costs for employees and hospital facilities. For the infant: treatment at neonatal ward/children's hospital if needed in connection to the time of delivery.


Previous secondary outcome measures:
1. Data on background variables and secondary maternal outcomes will be obtained from the Pregnancy Register about 3 months after delivery (the Pregnancy Registry is a Certified National Quality Registry initiated by the Swedish Healthcare that collect and process information all the way from early pregnancy to a few months after birth).
1.1. Chorioamnionitis
1.2. Use of oxytocin
1.3. Use of epidural anesthesia
1.4. Shoulder dystocia
1.5. Caesarean section
1.6. Assisted vaginal delivery
1.7. Forceps
1.8. Vacuum extraction
1.9. Perineal lacerations III-IV
1.10. Postpartum hemorrhage (>1000 ml) (no/yes)
1.11. Duration of labour (minutes)
1.12. Wound infection
1.13. Urinary tract infection
1.14. Endometritis, sepsis (no/yes)
2. Breastfeeding at 3 months and 6 months
3. Patient-, Cause of Death-, and Prescribed Drug Registers after delivery
4. The following data on women’s attitudes, experiences and health-related quality of life will be collected, only in the Region Vastra Götaland subpopulation, by questionnaires (web based or postal) after randomisation:
4.1. Personality (Big Five)
4.2. Depression/anxiety (HADS)
4.3. Health related quality of life (Euro-Qol –VAS & Euro-Qol-5D)
4.4. Self-efficacy (The General Self-Efficacy Scale (GES)
5. The following data on women’s attitudes, experiences and health-related quality of life will be collected, only in the Region Vastra Götaland subpopulation, by quest

Secondary ID(s)

N/A

Source(s) of Monetary Support

The Foundation of the Health and Medical Care Committee of the Region Vastra Gotaland, Stiftelsen Handlanden Hjalmar Svenssons, Health Technology Centre (HTA) at Sahlgrenska University Hospital, Stiftelsen Mary von Sydows, född Wijk, donationsfond, Uppsala-Örebro Regional Research Council, Centre for Clinical Research Dalarna-Uppsala University, ALF-agreement Region Vastra Gotaland, ALF-agreement Region Stockholm, ALF-agreement for Region Örebro County, Regional Research Council Uppsala-Örebro and Region Örebro Research Council

Results

• Results available: Yes
• Date Completed: 31/05/2020