Condition category
Pregnancy and Childbirth
Date applied
21/03/2015
Date assigned
30/03/2015
Last edited
21/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
About 15-20% of all women’s pregnancies last 41 gestational weeks or longer. This leads to greater risks for the woman and the child, but we still lack sufficient evidence how to manage these pregnancies. Nevertheless, worldwide, induction before 42 gestational weeks has been increasingly common. The standard care in Sweden today is induction at 42 gestational weeks. We are carrying out a study to investigate if a policy of induction of labour at 41 gestational weeks is better for the health of children and mothers, as compared to expectant management and induction at 42 gestational weeks. In addition, we also want to evaluate women’s attitudes and experiences of early induction and late induction of labour. Our goal is to find the optimal timing of offering induction of labour to women at late term (41 gestational weeks) or post-term (42 gestational weeks).
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Who can participate?
The study aims to recruit about 10,000 healthy pregnant women, age 18 years or over, with a normal singleton pregnancy at 41 gestational weeks across Sweden.

What does the study involve?
Over a period of three years pregnant women at 40 gestational weeks will be invited to participate in the study. Women who are interested in participating in the study are booked for a visit at the antenatal clinic at the respective hospital at 41 gestational weeks. Further information is given and after written consent an ultrasound examination is performed. The women will be randomly allocated to undergo either induction of labour at 41 gestational weeks or expectant management and induction at 42 gestational weeks. All inductions will be performed with the women staying at the hospital until delivery. The clinic’s protocol and guidelines for induction and surveillance during induction will be followed. At the end of the study, we will evaluate if induction of labour at 41 gestational weeks is better for the health of children and mothers, as compared to expectant management and induction at 42 gestational weeks. In addition, we also compare women’s attitudes and experiences of induction of labour at 41 gestational weeks and expectant management and induction at 42 gestational weeks.

What are the possible benefits and risks of participating?
A possible benefit is that an ultrasound examination is performed at 41 gestational weeks. If the result shows low or high foetal weight or abnormal levels of amniotic fluid the women will not be included in the study but followed-up according to clinical routine. Otherwise, there will be no immediate direct benefit to those taking part. However, there should be future benefits for the health of children and mothers because the results of the study are likely to stipulate the optimal timing of offering induction of labour to women at late term (41 gestational weeks) or post-term (42 gestational weeks). There are no risks of participating in this study

Where is the study run from?
The study has been set up by the Universities of Gothenburg, Stockholm, Uppsala and Lund in collaboration with SAS (South of Alvborgs community).

When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start in September 2016. Participants will be enrolled on the study for a period of 3 years; however, the study will extend beyond this as we intend to follow up the children’s health to the age of 4 years.

Who is funding the study?
Funding has been provided by the Foundation of the Health and Medical care committee of the Region of Vastra Gotaland, Sweden, the Health Technology Centre and grants from Swedish governmental grants to researchers in the public health service.

Who is the main contact?
Associate Professor, PhD Helen Elden

Trial website

Contact information

Type

Scientific

Primary contact

Prof Helen Elden

ORCID ID

Contact details

Perinatal centre
Department of Obstetrics and Gynecology
Institute of Clinical Sciences
Sahlgrenska Academy
East Hospital
Gothenburg
416 85
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

This study aims to investigate whether a policy of induction of labour at 41 gestational weeks is superior for the health of children and mothers, as compared to expectant management and induction at 42 gestational weeks. The literature lends some support to induction taking place in 41-42 gestational weeks may reduce the risk of perinatal death and mekonium aspiration without increasing the risk of caesarean section or negative childbirth experiences. However, a large number of women need to be induced to prevent a case of perinatal death (NNT=469). There are also significant methodological problems in both published individual studies and systematic reviews. This is because important adverse outcomes such as PNM and HIE are very rare in developed countries. Large multicentre studies are therefore needed.
The study we propose here will show if the optimal timing of induction of labour is at 41 gestational weeks or 42 gestational weeks, define any adverse effects for mother and child, ascertain whether women find the intervention acceptable, and will calculate the costs for the NHS.

Added 01/08/2013:
The aims of the qualitative research in the project are to describe the women's and their partners lifeworld experiences about post-term pregnancy. The target numbers of participants for the qualitative study are 10 women and 7 partners.
Overall trial start date of qualitative study: 19/08/2013
Recruitment start date of qualitative study: 10/08/2013
Recruitment end date of qualitative study: 15/12/2015

Ethics approval

1. The Regional Ethics Board in Gothenburg, Sweden, May 2014, Dnr: 285-14
2. Qualitative study: Regional Ethics Committee in Gothenburg, ref: 313-13

Study design

Multicentre register-based randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Post-term birth

Intervention

Intervention group: Women randomised to early induction will be induced the same day as randomisation or the next day after randomisation. Thus induction will take place at GW 41+0-41+2.

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

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

Added 17/08/2015:
Qualitative study:
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 a postterm pregnancy.
The partners will be encouraged to describe experiences regarding everyday life with the postterm pregnant partner. The interviews will last about 60 minutes and will be tape-recorded. All interviews will be transcribed verbatim. The data will be analysed using phenomenological analysis.
The women and their partners will be re-interviewed within 4 weeks after delivery. The same questions will be asked. Thus, the women will be asked to describe how they experienced their postterm pregnancy. Consequently, the partners will be asked to describe experiences regarding everyday life with the postterm pregnant partner.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

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 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 questionnaires (web-based or postal) 3 months after randomisation:
5.1. Health-related quality of life (Euro-Qol –VAS & Euro-Qol-5D)
5.2. The General Self-Efficacy Scale (GES)
5.3. Depression/anxiety (HADS)
5.4. The Childbirth Experience Questionnaire (CEQ)
6. For counties with the same Obstetrix record we will register data on satisfaction with delivery (VAS 0-10)
7. Cost-effectiveness analyses will be performed comparing induction at GW 41+0 with induction at GW 42+0. For example: the woman’s visits to midwife and obstetrician, antenatal surveillance, sick leave, quality-adjusted life year (QUALY), 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: visits to neonatal ward/children's hospital and to nurse and MD at Swedish Child Health care during the first 3 months after birth.
8. Data on neonatal outcomes will be obtained from the SNQ (Swedish Neonatal Quality Register) after delivery:
8.1. Admittance to neonatal intensive care unit,(no/yes)
8.2. Birth weight (grams)
8.3. Macrosomia (no/yes)
8.4. Shoulder dystocia ,(no/yes),
8.5. Apgar score <4 at 5 minutes ,(no/yes)
8.6. Therapeutic hypothermia ,(no/yes)
8.7. Neonatal jaundice (no/yes)
8.8. Treatment for neonatal jaundice for example: light therapy (no/yes), bloodtransfusion ,(no/yes),
8.9. Pneumonia ,(no/yes)
8.10. Sepsis ,(no/yes)
8.11. Cerebral palsy (no/yes)
9. The Swedish Child Health Quality Register will be used for collection of data on breastfeeding at 6 months and 1 year. We intend to follow neurodevelopment at childhood at 2 years and 4 years and death during the first 4 years of life.

Added 17/08/2015:
Qualitative study:
Open-ended interviews will be conducted with 10 women and 7 partners before the start of the RCT. This part of the study will be focused of the women’s experiences of a postterm pregnancy. Their partners will be interviewed of their experiences regarding everyday life with the postterm pregnant partner.

Overall trial start date

01/09/2015

Overall trial end date

31/12/2019

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 10,038 women

Participant 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

Recruitment start date

01/09/2016

Recruitment end date

31/08/2019

Locations

Countries of recruitment

Sweden

Trial participating centre

Sahlgrenska University Hospital
Perinatal Centre Department of Obstetrics and Gynecology Institute of Clinical Sciences Sahlgrenska Academy East Hospital
Gothenburg
416 85
Sweden

Trial participating centre

Karolinska University Hospital
Karolinska vägen
Stockholm
171 76
Sweden

Trial participating centre

Skane University Hospital
Sodra Förstadsgatan 101
Malmo
214 28
Sweden

Trial participating centre

Uppsala University hospital
Akademiska sjukhuset
Uppsala
751 85
Sweden

Trial participating centre

South Alvsborgs Hospital, Boras
Brämhultsvägen 53
Boras
-
Sweden

Sponsor information

Organisation

Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University

Sponsor details

Perinatal centre
Department of Obstetrics and Gynecology
East Hospital
Gothenburg
S-416 85
Sweden

Sponsor type

Hospital/treatment centre

Website

http//www.sahlgrenska.se

Funders

Funder type

Government

Funder name

The Foundation of the Health and Medical care committee of the Region of Vastra Gotaland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swedish governmental grants to researchers in the public health service

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Health Technology Centre (HTA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study protocol is published (see below). Date for publishing of results to be confirmed at a later date.

Intention to publish date

Participant level data

Other

Results - basic reporting

Publication summary

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/26951777

Publication citations

Additional files

Editorial Notes

21/11/2016: The following changes were made to the trial record: 1. The recruitment start date was changed from 01/09/2015 to 01/09/2016. 2. The recruitment end date was changed from 31/08/2018 to 31/08/2019. 3. The overall trial end date was changed from 31/12/2018 to 31/12/2019. 03/10/2016: Publication reference added. 17/08/2015: This record was updated to include details of a qualitative study that started on 01/08/2013. All details of this qualitative study can be found in the relevant sections under the above title.